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This program is sponsored by and the speaker is presenting on behalf of Lilly USA, LLC.
It is being presented consistent with FDA guidelines and is not approved for continuing education credit. Note to Speaker: Please read disclaimer.

The goal of this program is to review information pertinent to the topic and answer your questions.
For questions that directly relate to this topic and/or are consistent with product labeling, I will respond during the program. For all other questions, I will be glad to talk with you individually at the conclusion of the program. Note to Speaker: Review the goal of the program and the questions policy.

WELCOME Trulicity: A case study in treating adult patients with type 2 diabetes DG / ©Lilly USA, LLC All rights reserved. In the Participant Guide, please see Important Safety Information, including Boxed Warning about possible thyroid tumors including thyroid cancer, the Full Prescribing Information, and Medication Guide.

Indication Trulicity™ (dulaglutide) is a glucagon-like peptide-1 receptor agonist (GLP-1 RA) that is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use Not recommended as first-line therapy for patients inadequately controlled on diet and exercise because of the uncertain relevance of rodent C-cell tumor findings to humans. Prescribe only if potential benefits outweigh potential risks. Has not been studied in patients with a history of pancreatitis. Consider other antidiabetic therapy. Not for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis. Not a substitute for insulin. Has not been studied in patients with severe gastrointestinal disease, including severe gastroparesis. Not for patients with pre‐existing severe gastrointestinal disease. Has not been studied in combination with basal insulin. Note to Speaker: Please read Indication Statement and Limitations of Use. Trulicity [Prescribing Information]. Indianapolis, IN: Lilly USA, LLC; 2015.

Important Safety Information—Boxed Warning
WARNING: RISK OF THYROID C-CELL TUMORS In male and female rats, dulaglutide causes a dose-related and treatment-duration-dependent increase in the incidence of thyroid C-cell tumors (adenomas and carcinomas) after lifetime exposure. It is unknown whether Trulicity causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans as human relevance of dulaglutide-induced rodent thyroid C-cell tumors has not been determined. Trulicity is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Counsel patients regarding the potential risk of MTC with use of Trulicity and inform them of symptoms of thyroid tumors (eg, mass in the neck, dysphagia, dyspnea, persistent hoarseness). Routine monitoring of serum calcitonin or using thyroid ultrasound is of uncertain value for early detection of MTC in patients treated with Trulicity. Note to Speaker: Please read Boxed Warning. Trulicity [Prescribing Information]. Indianapolis, IN: Lilly USA, LLC; 2015.

Important Safety Information (continued)
Trulicity is contraindicated in patients with a personal or family history of MTC or in patients with MEN 2, and in patients with a prior serious hypersensitivity reaction to dulaglutide or any of the product components. Risk of Thyroid C-cell Tumors: Cases of MTC in patients treated with liraglutide, another GLP-1 receptor agonist, have been reported in the postmarketing period; the data in these reports are insufficient to establish or exclude a causal relationship between MTC and GLP-1 RA use in humans. If serum calcitonin is measured and found to be elevated or thyroid nodules are noted on physical examination or neck imaging, the patient should be further evaluated. Pancreatitis: Has been reported in clinical trials. Observe patients for signs and symptoms including persistent severe abdominal pain. If pancreatitis is suspected, discontinue Trulicity promptly. Do not restart if pancreatitis is confirmed. Consider other antidiabetic therapies in patients with a history of pancreatitis. Hypoglycemia: The risk of hypoglycemia is increased when Trulicity is used in combination with insulin secretagogues (eg, sulfonylureas) or insulin. Patients may require a lower dose of the sulfonylurea or insulin to reduce the risk of hypoglycemia. Note to Speaker: Please read Important Safety Information for once-weekly Trulicity™ (dulaglutide). Trulicity [Prescribing Information]. Indianapolis, IN: Lilly USA, LLC; 2015.

Pathogenesis of type 2 diabetes
The pathogenesis of diabetes is multifactorial Insulin resistance in muscle and liver and β-cell failure represent the core pathophysiologic defects in type 2 diabetes In addition to the fat cell, the GI tract, the α-cell, kidneys, and brain all play important roles in developing glucose intolerance Decreased incretin effect Islet α-cell Increased glucagon secretion Increased hepatic glucose production Increased lipolysis Increased glucose reabsorption Decreased glucose uptake Neurotransmitter dysfunction Decreased insulin secretion Hyperglycemia Note to Speaker: This slide is animated. Main Point Glucose control is a multi-organ process, involving the ominous octet1 Additional Points The pathophysiology of type 2 diabetes involves characteristic defects in several main organ systems that collaborate to produce abnormal glucose metabolism1 Peripheral tissues1,2 Lipolysis (increased in adipose tissue)1 Glucose uptake and utilization (eg, skeletal muscle)1-3 Gluconeogenesis1 Pancreas3,4 β-cells: insufficient insulin secretion3,4 α-cells: glucagon secretion increased4 Central nervous system4 Food intake and satiety Hormone regulation Digestive system5 Glucose absorption Incretin hormones Glucagon-like peptide-1 (GLP-1) has specific effects on pancreatic α-cells and β-cells, the hypothalamus, and the gastrointestinal (GI) system4 By inhibiting glucagon secretion and delaying gastric emptying (contributing to glucose absorption), GLP-1 plays an important role in glucose homeostasis4 and regulation of food intake and satiety5; under normal circumstances, the collaboration of these organ systems ensures a tight regulation of an individual’s glycemic state References DeFronzo RA. Banting Lecture. From the triumvirate to the ominous octet: a new paradigm for the treatment of type 2 diabetes mellitus. Diabetes. 2009;58(4): DeFronzo RA, Gunnarsson R, Björkman O, Olsson M, Wahren J. Effects of insulin on peripheral and splanchnic glucose metabolism in noninsulin-dependent (type II) diabetes mellitus. J Clin Invest. 1985;76(1): DeFronzo RA, Tripathy D. Skeletal muscle insulin resistance is the primary defect in type 2 diabetes. Diabetes Care. 2009;32(suppl 2):S157- S163. Girard J. The incretins: from the concept to their use in the treatment of type 2 diabetes. Part A: incretins: concept and physiological functions. Diabetes Metab. 2008;34(6 Pt 1): Flint A, Raben A, Astrup A, Holst JJ. Glucagon-like peptide 1 promotes satiety and suppresses energy intake in humans. J Clin Invest ;101(3): GI = gastrointestinal. Defronzo RA. Diabetes. 2009;58(4):

American Diabetes Association/EASD and AACE: Recommend reviewing treatment ~3 months
Treatment guidelines recommend assessing patient progress in reaching goal approximately every 3 months and then1-3: treatment when A1C goal not reached Modify Maintain treatment when A1C goal is reached Note to Speaker: This slide is animated. Main Point1-3 The American Diabetes Association/EASD and American Association of Clinical Endocrinologists (AACE) recommend assessing progress toward reaching glycemic goals approximately every 3 months and then either modifying the therapy if the goal is not met or maintaining the therapy if the goal has been reached References Inzucchi SE, Bergenstal RM, Buse JB, et al. Management of hyperglycemia in type 2 diabetes: a patient-centered approach. Position statement of the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD) [published correction appears in Diabetes Care. 2013;36(2):490] Diabetes Care ;35(6): American Association of Clinical Endocrinologists and American College of Endocrinology. Clinical Practice Guidelines for Developing a Diabetes Mellitus Comprehensive Care Plan Endocr Pract. 2015;21(suppl 1):1-87. Inzucchi SE, Bergenstal RM, Buse JB, et al. Management of hyperglycemia in type 2 diabetes, 2015: a patient- centered approach: update to a position statement of the American Diabetes Association (ADA) and the European Association for the Study of Diabetes. Diabetes Care. 2015;38(1): AACE = American Association of Clinical Endocrinologists. 1. Inzucchi SE, et al. Diabetes Care. 2012;35(6): AACE/ACE Diabetes Guidelines, Endocr Pract. 2015;21(Suppl 1): Inzucchi SE, et al. Diabetes Care. 2015;38(1):

Patients are reluctant to initiate injectable therapies1-3
Patient beliefs surrounding injectable therapies Lifestyle burdens4,5 Indication of disease progression1,4 Feelings of failure and guilt for not adhering to previous treatment1,4 Note to Speaker: This slide is animated on clicks. Main Point Once patients have reached the point in their treatment continuum where it is time to add an injectable therapy, many pre-existing beliefs make them reluctant to initiate injectable therapies1-4 Additional Points Patient beliefs surrounding injectable therapies Lifestyle burdens7,8 Indication of disease progression5,7 Feelings of failure and guilt for not adhering to previous treatment5,7 Fearful and anxious about injections5,6 Fear of needles6 Fear of painful injections6,8 References Garber AJ, Abrahamson MJ, Barzilay JI, et al. AACE comprehensive diabetes management algorithm Endocr Pract. 2013;19(2): American Diabetes Association. Standards of medical care in diabetes Diabetes Care. 2015;38(suppl 1):S1-S93. Inzucchi SE, Bergenstal RM, Buse JB, et al. Management of hyperglycemia in type 2 diabetes: a patient- centered approach. Position statement of the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD) [published correction appears in Diabetes Care. 2013;36(2):490] Diabetes Care. 2012;35(6): Ost LG. Acquisition of blood and injection phobia and anxiety response patterns in clinical patients. Behav Res Ther. 1991;29(4): Joy SV. Clinical pearls and strategies to optimize patient outcomes. Diabetes Educ. 2008;34 (suppl 3):54S-59S. Rubin RR, Peyrot M, Kruger DF, Travis LB. Barriers to insulin injection therapy: patient and health care provider perspectives. Diabetes Educ. 2009;35(6): Korytkowski M. When oral agents fail: practical barriers to starting insulin. Int J Obes Relat Metab Disord ;26(suppl 3):S18-S24. Karter A, Subramanian U, Saha C, et al. Barriers to insulin initiation: the Translating Research into Action for Diabetes Insulin Starts Project. Diabetes Care. 2010;33(4): Fearful and anxious about injections1,3 Fear of needles3 Fear of painful injections3,5 1. Joy SV. Diabetes Educ. 2008;34(suppl 3):54S-59S. 2. Öst LG. Behav Res Ther. 1991;29(4): Rubin RR, et al. Diabetes Educ. 2009;35(6): Korytkowski M. Int J Obesity. 2002;26(suppl 3):S18-S Karter AJ, et al. Diabetes Care. 2010;33(4):

Once-weekly Trulicity™: the molecule
A recombinant GLP-1 Fc fusion protein linking a human GLP-1 peptide analog and a variant of a human IgG4-Fc fragment result in a 63-kDa molecule1 that met the following development goals2,3 Once-weekly dosing1 Extended plasma half-life (~5 days) Minimal renal clearance1 GLP-1 analog Linker Does not require reconstitution4 Low immunogenicity1,2 Percentage of patients who developed Trulicity antidrug antibodies in clinical studies was 1.6%1 Note to Speaker: This slide is animated on clicks. Main Points The goals of Trulicity molecular development were to1 Offer extended incretin activity to allow once-weekly administration Be soluble to eliminate the need for reconstitution and allow delivery via a small-gauge needle Have low potential for immunogenicity4 These goals were achieved through the molecular engineering of Trulicity, a 63-kDa molecule2 that Is administered once weekly2 The extended plasma half-life is approximately 5 days Does not require reconstitution3 Has minimal renal clearance4 Has low immunogenicity1,2 Percentage of patients who developed Trulicity antidrug antibodies in clinical studies was 1.6%2 References Data on File. Eli Lilly and Company; 2014, TRU A. Trulicity [Prescribing Information]. Indianapolis, IN: Lilly USA, LLC; 2015. Trulicity [Instructions for Use]. Indianapolis, IN: Lilly USA, LLC; 2014. Umpierrez G, Blevins T, Rosenstock J, Cheng C, Anderson JH, Bastyr EJ 3rd. The effects of LY , a long- acting glucagon-like peptide-1 analogue, in a randomized, placebo-controlled, double-blind study of overweight/obese patients with type 2 diabetes: the EGO study. Diabetes Obes Metab. 2011;13(5): Modified IgG4-Fc domain Fc = fragment crystallization; IgG = immunoglobulin G. 1. Trulicity [Prescribing Information]. Indianapolis, IN: Lilly USA, LLC; Data on File. Eli Lilly and Company; 2014, TRU A. 3. Umpierrez G, et al. Diabetes Obes Metab. 2011;13(5): Trulicity [Instructions for Use]. Indianapolis, IN: Lilly USA, LLC; 2014.

Hypersensitivity Reactions: Systemic reactions were observed in patients receiving Trulicity in clinical trials. Instruct patients who experience symptoms to discontinue Trulicity and promptly seek medical advice. Renal Impairment: In patients treated with GLP-1 RAs, there have been postmarketing reports of acute renal failure and worsening of chronic renal failure, sometimes requiring hemodialysis. A majority of reported events occurred in patients who had experienced nausea, vomiting, diarrhea, or dehydration. In patients with renal impairment, use caution when initiating or escalating doses of Trulicity and monitor renal function in patients experiencing severe adverse gastrointestinal reactions. Severe Gastrointestinal Disease: Use of Trulicity may be associated with gastrointestinal adverse reactions, sometimes severe. Trulicity has not been studied in patients with severe gastrointestinal disease, including severe gastroparesis, and is therefore not recommended in these patients. Note to Speaker: Please read Important Safety Information for once-weekly Trulicity™ (dulaglutide). Trulicity [Prescribing Information]. Indianapolis, IN: Lilly USA, LLC; 2015.

Treatment considerations
Case study Jim* Meet Jim* Treatment considerations He is reluctant to move to injectable therapy Frustrated he is not achieving diabetes goals Takes small steps to manage diabetes Currently on dual OAM Busy man in his mid‑50s Time to add therapy but… Diabetes duration: 7 years Family and career keep him going Goal A1C: 7.0% Last visit A1C: 8.2% Note to Speaker: This slide is animated on clicks. *Hypothetical patient. OAM = oral antihyperglycemic medication. Trulicity is not indicated for weight loss. Weight change was a secondary endpoint in clinical trials. In the Participant Guide, please see Important Safety Information, including Boxed Warning about possible thyroid tumors including thyroid cancer, the Full Prescribing Information, and Medication Guide.

Given these considerations, what therapy might you add?
Efficacy Hypoglycemia Weight Major adverse reaction(s) Cost Add a DPP-4 inhibitor Add a GLP-1 RA Add insulin Note to Speaker: This slide is animated. Speaker Direction Given your most important considerations and the guidelines, what additional therapy will you recommend for Jim? Encourage the audience to come to a consensus on which therapy they would recommend If they add a DPP-4 inhibitor, jump to that efficacy section by clicking on the text or the associated colored button If they choose to add a GLP-1 RA, jump to that efficacy section by clicking on the text or the associated colored button If they choose insulin, jump to that efficacy section by clicking on the text or the associated colored button If the audience doesn’t come to a consensus, that’s okay; simply choose 1 treatment option to consider first, and follow up with the others later; there will be a navigation option at the end of each section to return to this screen DPP-4 = dipeptidyl peptidase-4.

Once-weekly Trulicity compared to Januvia® (sitagliptin): AWARD-5
Design: 104‐week, randomized, placebo‐controlled, double‐blind phase 3 study of adult patients with type 2 diabetes Primary outcome measure: Noninferiority of Trulicity 1.5 mg to Januvia 100 mg on A1C change from baseline at 52 weeks Dose finding Primary time point Final time point Trulicity (mg) 0.25 0.50 Diabetes Duration Years (Mean) Metformin 7 Trulicity 0.75 mg 1.0 7 Trulicity 1.5 mg Safety follow-up 2.0 3.0 7 Januvia 100 mg 7 Januvia 100 mg Placebo Lead-in Treatment period Follow-up Main Points1,2 Assessment of Weekly AdministRation of LY in Diabetes (AWARD)-5 was a 104‐week, randomized, placebo‐controlled, double‐blind phase 3 study of adult patients with type 2 diabetes treated with metformin 1500 mg/day Primary objective was to demonstrate noninferiority of Trulicity 1.5 mg vs Januvia on A1C change from baseline at 52 weeks (‐1.1% vs ‐0.4%, respectively; difference of ‐0.7%; 95% confidence interval [CI] [‐0.9, ‐0.5]; multiplicity‐adjusted 1-sided alpha level of for noninferiority with 0.25% margin; analysis of covariance using last observation carried forward [LOCF]); primary objective met Secondary efficacy measures included change from baseline in A1C at other time points; percentage of patients with A1C 7.0% (53 mmol/mol) or 6.5% (48 mmol/mol); body weight, fasting plasma glucose (FPG; central laboratory measure), and fasting insulin; β-cell function and insulin sensitivity indices (updated homeostasis model assessment 2 [HOMA2]); and lipids Eligible patients were those years of age, had type 2 diabetes (6 months) with an A1C value of 8% and 9.5% on diet and exercise alone or 7% and 9.5% on oral antihyperglycemic medication (OAM) monotherapy or combination therapy (metformin plus another OAM), a body mass index (BMI) between 25 and 40 kg/m2, and a stable weight during the 3-month period before entering the study Patients were excluded if they were taking GLP-1 RAs during the 6 months prior to screening or were on chronic insulin therapy All patients underwent a metformin run-in period that lasted up to 11 weeks and continued throughout the study; other OAMs were discontinued; during a dose-finding portion of the study, seven doses of Trulicity were evaluated along with sitagliptin and placebo; Trulicity 1.5 mg and 0.75 mg were selected for further evaluation and those patients assigned to the doses and comparators continued forward in the study Patients in the Januvia arms received 100 mg once daily References Trulicity [Prescribing information]. Indianapolis, IN: Lilly USA, LLC; 2015. Nauck M, Weinstock RS, Umpierrez GE, Guerci B, Skrivanek Z, Milicevic Z. Efficacy and safety of dulaglutide versus sitagliptin after 52 weeks in type 2 diabetes in a randomized controlled trial (AWARD-5). Diabetes Care ;37(8): -11 26 52 104 108 Weeks All patients underwent a metformin run-in period that lasted up to 11 weeks and continued throughout the study; other oral antihyperglycemic medications were discontinued. During a dose-finding portion of the study, seven doses of Trulicity were evaluated along with sitagliptin and placebo. Trulicity 1.5 mg and 0.75 mg were selected for further evaluation and those patients assigned to the doses and comparators continued forward in the study. Recommended starting dose is 0.75 mg. Dose can be increased to 1.5 mg for additional glycemic control. AWARD = Assessment of Weekly AdministRation of LY in Diabetes. Nauck M, et al. Diabetes Care. 2014;37(8):

Trulicity showed superior A1C reduction* vs Januvia®1-3
Week 52 Trulicity (0.75 mg) (n=281; Baseline A1C: 8.2%) Januvia® (100 mg) (n=273; Baseline A1C: 8.0%) Trulicity (1.5 mg) (n=279; Baseline A1C: 8.1%) -0.4 -0.9† -1.1† -0.2 -0.4 -0.6 Mean A1C change from baseline (%) -0.8 The most commonly reported treatment-emergent adverse events were gastrointestinal-related.1 -1.0 -1.2 -1.4 -1.6 Data represent least-squares (LS) mean ± standard error (SE). Note to Speaker: This slide is animated. Main Point Trulicity showed clinically significant A1C reduction1 Additional Points At the 52‐week primary endpoint, mean A1C reductions were Trulicity 1.5 mg: 1.1%; Trulicity 0.75 mg: 0.9%; Januvia: 0.4%1 Study groups Januvia 100 mg (n=273; Baseline A1C: 8.0%) Trulicity 0.75 mg (n=281; Baseline A1C: 8.2%) Trulicity 1.5 mg (n=279; Baseline A1C: 8.1%) Study description 104‐week, randomized, placebo‐controlled, double‐blind phase 3 study of adult patients with type 2 diabetes treated with metformin 1500 mg Primary objective was to demonstrate noninferiority of Trulicity 1.5 mg vs Januvia on A1C change from baseline at 52 weeks (‐1.1% vs ‐0.4%, respectively; difference of ‐0.7%; 95% CI [‐0.9, ‐0.5]; multiplicity‐adjusted 1‐sided alpha level of for noninferiority with 0.25% margin2; analysis of covariance using LOCF); primary objective met References Trulicity [Prescribing information]. Indianapolis, IN: Lilly USA, LLC; 2015. Data on file, Lilly USA, LLC. TRU A. *In clinical studies, the range of A1C reduction from baseline was 0.7% to 1.6% for the 0.75 mg dose and 0.8% to 1.6% for the 1.5 mg dose.1,4 Select Important Safety Information: Counsel patients regarding the risk of medullary thyroid carcinoma with Trulicity and the symptoms of thyroid tumors (eg, a mass in the neck, dysphagia, dyspnea, persistent hoarseness). Patients with elevated serum calcitonin (if measured) and patients with thyroid nodules noted on physical examination or neck imaging should be referred to an endocrinologist for further evaluation. †Multiplicity-adjusted 1-sided P value .001, for superiority of Trulicity compared to Januvia. Analysis of covariance using last observation carried forward (LOCF). 1. Trulicity [Prescribing Information]. Indianapolis, IN: Lilly USA, LLC; Data on file, Lilly USA, LLC. TRU B. 3. Data on file, Lilly USA, LLC. TRU A. 4. Dungan et al. Lancet. 2014;384:

Data presented are secondary endpoints.
Trulicity 1.5 mg helped 59% of patients, and Trulicity 0.75 mg helped 49% of patients achieve A1C 7%1,2 100 Trulicity (1.5 mg) (n=279; Baseline A1C: 8.1%) Trulicity (0.75 mg) (n=281; Baseline A1C: 8.2%) Januvia® (100 mg) (n=273; Baseline A1C: 8.0%) 90 80 70 59%* *P<0.001 Trulicity compared to Januvia.1 60 49%* Patients achieving A1C 7.0% (%) 50 40 33% 30 20 10 Note to Speaker: This slide is animated. Main Point In a clinical study, once‐weekly Trulicity 1.5 mg helped 59% of patients, and 0.75 mg helped 49% of patients achieve A1C 7% Additional Points After 52 weeks of treatment, the percentage of patients attaining the target A1C goal of 7.0% (53 mmol/mol) was higher in the Trulicity 1.5 mg and Trulicity 0.75 mg arms (59% and 49%, respectively) compared with Januvia (33%) At the same endpoint, 42% and 29% of patients in the Trulicity 1.5 and 0.75 mg arms, respectively, achieved A1C targets of 6.5% (48 mmol/mol) compared with 19% in the Januvia arm (data not shown) Primary objective was to demonstrate noninferiority of Trulicity 1.5 mg vs Januvia on A1C change from baseline at 52 weeks (-1.1% vs -0.4%, respectively; difference of -0.7%; 95% CI [-0.9, -0.5]; multiplicity-adjusted 1-sided alpha level of for noninferiority with 0.25% margin; analysis of covariance using LOCF); primary objective met Data presented are secondary endpoints Secondary efficacy measures included change from baseline in A1C at other time points; percentage of patients with A1C 7.0% (53 mmol/mol) or 6.5% (48 mmol/mol); body weight, fasting plasma glucose (FPG; central laboratory measure), and fasting insulin; β-cell function and insulin sensitivity indices (updated HOMA2); and lipids References Trulicity [Prescribing Information]. Indianapolis, IN: Lilly USA, LLC; 2015. Nauck M, Weinstock RS, Umpierrez GE, Guerci B, Skrivanek Z, Milicevic Z. Efficacy and safety of dulaglutide versus sitagliptin after 52 weeks in type 2 diabetes in a randomized controlled trial (AWARD-5). Diabetes Care ;37(8): Data on file, Lilly USA, LLC. TRU A. 52 weeks Data presented are secondary endpoints. In clinical studies, the percentage of patients achieving A1C 7% ranged from 37% to 69% for 0.75 mg and 53% to 78% for 1.5 mg.1,3-6 Select Important Safety Information: There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with Trulicity or any other antidiabetic drug. 1. Trulicity [Prescribing Information]. Indianapolis, IN: Lilly USA, LLC; Data on file, Lilly USA, LLC. TRU A. 3. Dungan KM et al. Lancet. 2014;384: Umpierrez G. et al. Diabetes Care. 2014;37: Giorgino F, et al. Presented at: American Diabetes Association Conference; San Francisco, CA: June 13-17, Jendle J, et al. Presented at: American Diabetes Association Conference; San Francisco, CA; June 13-17, 2014.

Once-weekly Trulicity showed weight reduction compared to Januvia® at 52 weeks1-3
Trulicity (1.5 mg) (n=279; Baseline Weight: lb) Trulicity (0.75 mg) (n=281; Baseline Weight: lb) Januvia (100 mg) (n=273; Baseline Weight: lb) -3.3 -6.0 -6.8 -1 -2 -3 -4 Mean weight change from baseline (lb) -5 -6 -7 -8 -9 -10 Note to Speaker: This slide is animated. Main Points This slide demonstrates the weight change associated with Trulicity 1.5 mg and 0.75 mg compared to Januvia1 Trulicity vs Januvia: The LS mean change from baseline in body weight at 52 weeks was -6.8 lb (-3.03 kg) for Trulicity 1.5 mg, -6.0 lb (-2.60 kg) for Trulicity 0.75 mg, and -3.3 lb (-1.53 kg) for Januvia1 Additional Point Trulicity is not indicated for weight loss; weight change was a secondary endpoint in clinical trials; mean weight change was -6.8 lb to -2.0 lb at the 1.5 mg dose and -6.0 lb to +0.4 lb at the 0.75 mg dose1,2 References Trulicity [Prescribing Information]. Indianapolis, IN: Lilly USA, LLC; 2015. Dungan KM, Povedano ST, Forst T, et al. Once-weekly dulaglutide versus once-daily liraglutide in metformin- treated patients with type 2 diabetes (AWARD-6): a randomised, open-label, phase 3, non-inferiority trial. Lancet. 2014;384(9951): Data represent LS mean ± SE. Trulicity is not indicated for weight loss. In AWARD studies 1-5, weight change was a secondary endpoint. Mean weight change was lb to -2.0 lb at the 1.5 mg dose and -6.0 lb to +0.4 lb at the 0.75 mg dose.1 Select Important Safety Information: Pancreatitis has been reported in clinical trials. Observe patients for signs and symptoms including persistent severe abdominal pain. If pancreatitis is suspected discontinue Trulicity promptly. Do not restart if pancreatitis is confirmed. Consider other antidiabetic therapies in patients with a history of pancreatitis. 1. Trulicity [Prescribing Information]. Indianapolis, IN: Lilly USA, LLC; Data on file, Lilly USA, LLC. TRU A. 3. Data on file, Lilly USA, LLC. TRU A.

Incidence of hypoglycemia*
Trulicity 1.5 mg (n=304) Trulicity™ 0.75 mg (n=302) Placebo (n=177) In a head-to-head study with Januvia Add-on to metformin (26 weeks) Documented symptomatic 1.1% 2.6% 5.6% Severe hypoglycemia† *For study description, see slide 14. Main Point The table shows the incidence of documented symptomatic hypoglycemia (70 mg/dL glucose threshold) and severe hypoglycemia in a head-to-head study with Januvia (add-on to metformin; 26 weeks) Additional Points1 Hypoglycemia was more frequent when Trulicity was used in combination with sulfonylurea or insulin Severe hypoglycemia occurred in 0% and 0.7% of patients when Trulicity 0.75 mg and 1.5 mg, respectively, were co-administered with a sulfonylurea; severe hypoglycemia occurred in 2.4% and 3.4% of patients when Trulicity 0.75 mg and 1.5 mg, respectively, were co-administered with prandial insulin The n numbers for the hypoglycemia data represent patients in the placebo-controlled 26-week period of the clinical trial; after 26 weeks, patients on placebo were given Januvia (100 mg) to keep blinding2 References Trulicity [Prescribing Information]. Indianapolis, IN: Lilly USA, LLC; 2015. Nauck M, Weinstock RS, Umpierrez GE, Guerci B, Skrivanek Z, Milicevic Z. Efficacy and safety of dulaglutide versus sitagliptin after 52 weeks in type 2 diabetes in a randomized controlled trial (AWARD-5). Diabetes Care ;37(8): Documented symptomatic hypoglycemia was defined as 70 mg/dL glucose threshold. †Severe hypoglycemia is defined as an episode requiring the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Select Important Safety Information: The risk of hypoglycemia is increased when Trulicity is used in combination with insulin secretagogues (eg, sulfonylureas) or insulin. Patients may require a lower dose of sulfonylurea or insulin to reduce the risk of hypoglycemia. Trulicity [Prescribing Information]. Indianapolis, IN: Lilly USA, LLC; 2015.

Trulicity 1.5 mg compared to Victoza® (liraglutide) 1.8 mg: AWARD-6
Design: 26‐week, randomized, open‐label comparator phase 3 study of adult patients with type 2 diabetes Primary outcome measure: Noninferiority of Trulicity 1.5 mg vs Victoza 1.8 mg on A1C change from baseline at 26 weeks Randomization Final time point Diabetes Duration Years (Mean) Metformin 7 Trulicity 1.5 mg once weekly + metformin Safety follow-up 7 Victoza 1.8 mg once daily + metformin Lead-in Treatment period Follow-up Main Points Assessment of Weekly AdministRation of LY in Diabetes (AWARD)-6 was a 26‐week, randomized, open‐label comparator phase 3 study of adult patients with type 2 diabetes treated with metformin 1500 mg/day Primary objective was to demonstrate noninferiority of Trulicity 1.5 mg vs Victoza 1.8 mg on A1C change from baseline at 26 weeks (‐1.42% vs ‐1.36%, respectively; difference of ‐0.06%; 95% CI [‐0.19, 0.07]; 2‐sided alpha level of 0.05 for noninferiority margin 0.4%; mixed model repeated measures analysis) Primary objective of noninferiority for A1C reduction was met; secondary endpoint of superiority was not met Consistent with product labeling, patients randomized to Victoza were initiated at 0.6 mg/day, uptitrated to 1.2 mg/day after week 1, and then to 1.8 mg/day after week 2 Reference Dungan KM, Povedano ST, Forst T, et al. Once-weekly dulaglutide versus once-daily liraglutide in metformin- treated patients with type 2 diabetes (AWARD-6): a randomised, open-label, phase 3, non-inferiority trial. Lancet. 2014;384(9951): -2 26 30 Week Victoza titration period Recommended starting dose is 0.75 mg. Dose can be increased to 1.5 mg for additional glycemic control. Dungan KM, et al. Lancet. 2014;384(9951):

Trulicity 1. 5 mg demonstrated comparable A1C reduction to Victoza® 1
Trulicity 1.5 mg demonstrated comparable A1C reduction to Victoza® 1.8 mg at 26 weeks1 8.2 Trulicity (1.5 mg) (n=299; Baseline A1C: 8.1%) Victoza (1.8 mg) (n=300; Baseline A1C: 8.1%) Primary objective was noninferiority vs Victoza 1.8 mg at 26 weeks; MMRM analysis. Primary objective met: P Secondary endpoint of superiority was not met. 8.0 7.8 Most common side effects were gastrointestinal. They were nausea, diarrhea, vomiting, and dyspepsia. 7.6 7.4 LS mean A1C (%) ±SE 7.2 * 7.0 85% fewer injections2 6.8 -1.36 -1.42 6.6 6.4 Note to Speaker: This slide is animated. Main Point Trulicity 1.5 mg demonstrated comparable A1C reduction to Victoza 1.8 mg at 26 weeks Additional Points Both Trulicity and Victoza significantly reduced A1C from baseline; the A1C reduction with Trulicity was noninferior to that achieved with Victoza Between-group difference in A1C reduction from baseline of -0.06% (95% CI [-0.19, 0.07], P.0001 for noninferiority) Decreases in A1C over time were similar between groups Reference Dungan KM, Povedano ST, Forst T, et al. Once-weekly dulaglutide versus once-daily liraglutide in metformin- treated patients with type 2 diabetes (AWARD-6): a randomised, open-label, phase 3, non-inferiority trial. Lancet. 2014;384(9951): Week 0 Week 8 Week 12 Week 26 Recommended starting dose of Trulicity is 0.75 mg. Dose can be increased to 1.5 mg for additional glycemic control. In clinical studies the range of A1C reduction from baseline was 0.7% to 1.6% for the 0.75 mg dose and 0.8% to 1.6% for the 1.5 mg dose.1,3 Select Important Safety Information: Use of Trulicity may be associated with gastrointestinal adverse reactions, sometimes severe. Trulicity has not been studied in and is not recommended for patients with a history of severe gastrointestinal disease (eg, severe gastroparesis). Consistent with product labeling, patients randomized to Victoza started at 0.6 mg/day in week 1, then were up-titrated to 1.2 mg/day in week 2 and to 1.8 mg/day in week 3. *American Diabetes Association recommended target goal. Treatment should be individualized.4 MMRM = mixed models, repeated measures. 1. Dungan KM, et al. Lancet. 2014;384(9951): Data on file, Lilly USA, LLC. TRU B. 3. Trulicity [Prescribing Information]. Indianapolis, IN: Lilly USA, LLC; American Diabetes Association. Diabetes Care 2015;38(Suppl. 1):S1-S93.

Trulicity 1.5 mg helped 68% of patients achieve A1C 7% at 26 weeks1
100 Trulicity (1.5 mg) (n=299; Baseline A1C: 8.1%) Victoza® (1.8 mg) (n=300; Baseline A1C: 8.1%) 90 80 68% 68% Most common side effects were gastrointestinal. They were nausea, diarrhea, vomiting, and dyspepsia. 70 60 Percentage of patients achieving A1C 7% 50 40 30 20 10 Data presented are secondary endpoints. Note to Speaker: This slide is animated. Main Point In a clinical study, Trulicity 1.5 mg helped 68% of patients achieve A1C 7% at 26 weeks Additional Point Both Trulicity and Victoza significantly reduced A1C from baseline; the A1C reduction with Trulicity was noninferior to that achieved with Victoza Reference Dungan KM, Povedano ST, Forst T, et al. Once-weekly dulaglutide versus once-daily liraglutide in metformin- treated patients with type 2 diabetes (AWARD-6): a randomised, open-label, phase 3, non-inferiority trial. Lancet. 2014;384(9951): Recommended starting dose of Trulicity is 0.75 mg. Dose can be increased to 1.5 mg. In clinical studies, the percentage of patients achieving A1C 7% ranged from 37% to 69% for 0.75 mg and 53% to 78% for 1.5 mg.1-5 Select Important Safety Information: Systemic hypersensitivity reactions were observed in patients receiving Trulicity in clinical trials. Instruct patients who experience symptoms to discontinue Trulicity and promptly seek medical advice. Consistent with product labeling, patients randomized to Victoza started at 0.6 mg/day in week 1, then were up-titrated to 1.2 mg/day in week 2 and to 1.8 mg/day in week 3. 1. Dungan KM, et al. Lancet. 2014;384(9951): Trulicity [Prescribing Information]. Indianapolis, IN: Lilly USA, LLC; Umpierrez G. et al. Diabetes Care. 2014;37: Giorgino F, et al. Presented at: American Diabetes Association Conference; San Francisco, CA: June 13-17, Jendle J, et al. Presented at: American Diabetes Association Conference; San Francisco, CA; June 13-17, 2014.

Once-weekly Trulicity 1.5 mg showed weight reduction at 26 weeks1
Trulicity (1.5 mg) (n=299; Baseline weight: lb) Victoza® (1.8 mg) (n=300; Baseline weight: lb) -7.96 -6.39 -1 -2 Weight change was a secondary endpoint -3 -4 Mean weight change from baseline (lb) -5 -6 -7 -8 -9 -10 Data represent LS mean ± SE. Note to Speaker: This slide is animated. Main Points This slide demonstrates the weight change associated with Trulicity 1.5 mg compared to Victoza 1.8 mg1 Trulicity 1.5 mg vs Victoza 1.8 mg: the least-squares (LS) mean change from baseline in body weight at 26 weeks was lb (-2.90 kg) for Trulicity 1.5 mg and lb (-3.61 kg) for Victoza 1.8 mg; mean difference 1.57 lb (0.71 kg)1 Additional Point Trulicity is not indicated for weight loss; weight change was a secondary endpoint in clinical trials; mean weight change was -6.8 lb to -2.0 lb at the 1.5 mg dose and -6.0 lb to +0.4 lb at the 0.75 mg dose1,2 References Dungan KM, Povedano ST, Forst T, et al. Once-weekly dulaglutide versus once-daily liraglutide in metformin- treated patients with type 2 diabetes (AWARD-6): a randomised, open-label, phase 3, non-inferiority trial. Lancet. 2014;384(9951): Trulicity [Prescribing Information]. Indianapolis, IN: Lilly USA, LLC; 2015. Trulicity is not indicated for weight loss. In AWARD studies 1-5, weight change was a secondary endpoint. Mean weight change was -6.8 lb to -2.0 lb at the 1.5 mg dose and -6.0 lb to +0.4 lb at the 0.75 mg dose.2 Select Important Safety Information: There have been postmarketing reports of acute renal failure and worsening of chronic renal failure, sometimes requiring hemodialysis, in patients treated with GLP‐1 receptor agonists. A majority of reported events occurred in patients who had experienced nausea, vomiting, diarrhea, or dehydration. In patients with renal impairment, use caution when initiating or escalating doses of Trulicity and monitor renal function in patients experiencing severe adverse gastrointestinal reactions. Consistent with product labeling, patients randomized to Victoza started at 0.6 mg/day in week 1, then were up-titrated to 1.2 mg/day in week 2 and to 1.8 mg/day in week 3. 1. Dungan KM, et al. Lancet. 2014;384(9951): Trulicity [Prescribing Information]. Indianapolis, IN: Lilly USA, LLC; 2015.

Trulicity™ 1.5 mg (n=299) Victoza 1.8 mg (n=300) In a head-to-head study with Victoza® 1.8 mg Add-on to metformin (26 weeks) Total hypoglycemia 6% 9% Total hypoglycemia: Events/patient/year 0.5 0.3 Severe hypoglycemia† *For study description, see slide 19. Main Point1 The table shows the incidence of total hypoglycemia (70 mg/dL glucose threshold), events per patient per year, and severe hypoglycemia in a head-to-head study with Victoza (add-on to metformin, 26 weeks) Additional Points2 Hypoglycemia occurred more frequently when Trulicity was used in combination with sulfonylurea or insulin Severe hypoglycemia occurred in 0% and 0.7% of patients when Trulicity 0.75 mg and 1.5 mg, respectively, were co-administered with a sulfonylurea; severe hypoglycemia occurred in 2.4% and 3.4% of patients when Trulicity 0.75 mg and 1.5 mg, respectively, were co-administered with prandial insulin References Dungan KM, Povedano ST, Forst T, et al. Once-weekly dulaglutide versus once-daily liraglutide in metformin- treated patients with type 2 diabetes (AWARD-6): a randomised, open-label, phase 3, non-inferiority trial. Lancet. 2014;384(9951): Trulicity [Prescribing Information]. Indianapolis, IN: Lilly USA, LLC; 2015. Documented symptomatic hypoglycemia was defined as 70 mg/dL glucose threshold. †Severe hypoglycemia is defined as an episode requiring the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Select Important Safety Information: The risk of hypoglycemia is increased when Trulicity is used in combination with insulin secretagogues (eg, sulfonylureas) or insulin. Patients may require a lower dose of sulfonylurea or insulin to reduce the risk of hypoglycemia. Dungan KM, et al. Lancet. 2014;384(9951):

Setting expectations and starting once-weekly Trulicity
Note to Speaker: This section will cover adverse reactions, Trulicity effect on fasting and postprandial glucose, and information about resources available to get patients started on Trulicity.

Macrovascular Outcomes: There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with Trulicity or any other antidiabetic drug. The most common adverse reactions reported in 5% of Trulicity-treated patients in placebo- controlled trials (placebo, Trulicity 0.75 mg, and Trulicity 1.5 mg) were nausea (5.3%, 12.4%, 21.1%), diarrhea (6.7%, 8.9%, 12.6%), vomiting (2.3%, 6.0%, 12.7%), abdominal pain (4.9%, 6.5%, 9.4%), decreased appetite (1.6%, 4.9%, 8.6%), dyspepsia (2.3%, 4.1%, 5.8%), and fatigue (2.6%, 4.2%, 5.6%). Gastric emptying is slowed by Trulicity, which may impact absorption of concomitantly administered oral medications. Use caution when oral medications are used with Trulicity. Drug levels of oral medications with a narrow therapeutic index should be adequately monitored when concomitantly administered with Trulicity. In clinical pharmacology studies, Trulicity did not affect the absorption of the tested, orally administered medications to a clinically relevant degree. Note to Speaker: Please read Important Safety Information for once-weekly Trulicity™ (dulaglutide). Trulicity [Prescribing Information]. Indianapolis, IN: Lilly USA, LLC; 2015.

Trulicity reduced fasting glucose levels1-3
Weeks 2 4 8 12 26 39 52 Trulicity (1.5 mg) (n=279; Baseline FPG: 173 mg/dL) Trulicity (0.75 mg) (n=281; Baseline FPG: 174 mg/dL) Placebo (n=139; Baseline FPG: 179 mg/dL) Januvia® (100mg) (n=273; Baseline FPG: 171 mg/dL) 10 A -10 FPG change from baseline (mg/dL, LS mean ± SE) -20 Data presented are secondary endpoints. Placebo was replaced with Januvia after 26 weeks to keep blinding. -30 -40 -50 104-week, randomized, placebo-controlled, double-blind phase 3 study of adult patients with type 2 diabetes treated with metformin 1500 mg. Primary objective was to demonstrate noninferiority of Trulicity 1.5 mg vs Januvia on A1C change from baseline at 52 weeks (-1.1% vs -0.4%, respectively; difference of -0.7%; 95% CI [-0.9, -0.5]; multiplicity-adjusted 1-sided alpha level of for noninferiority with 0.25% margin; analysis of covariance using last observation carried forward); primary objective met Note to Speaker: This slide is animated. Main Point Once-weekly Trulicity reduced mean fasting glucose levels1 Additional Points1 104-week, randomized, placebo-controlled, double-blind, phase 3 study of adult patients with type 2 diabetes treated with metformin 1500 mg Primary objective was to demonstrate noninferiority of Trulicity 1.5 mg vs Januvia on A1C change from baseline at 52 weeks (-1.1% vs -0.4%), respectively; difference of -0.7%; 95% CI (-0.9, -0.5); multiplicity-adjusted 1-sided alpha level of for noninferiority with 0.25% margin2; analysis of covariance using LOCF; primary objective met Data presented are secondary endpoints References Trulicity [Prescribing Information]. Indianapolis, IN: Lilly USA, LLC; 2015. Data on file, Lilly USA, LLC. TRU A. Data on file, Lilly USA, LLC. TRU A. Select Important Safety Information: Use of Trulicity may be associated with gastrointestinal adverse reactions, sometimes severe. Trulicity has not been studied in and is not recommended for patients with a history of severe gastrointestinal disease (eg, severe gastroparesis). FPG = fasting plasma glucose. 1. Trulicity [Prescribing Information]. Indianapolis, IN: Lilly USA, LLC; Data on file, Lilly USA, LLC. TRU A. 3. Data on file, Lilly USA, LLC. TRU A.

Trulicity reduced 2-hour postprandial glucose levels1,2
Trulicity (0.75 mg) (n=11) Trulicity (1.5 mg) (n=9) -39.8 -59.5 -10 -20 Placebo-adjusted LS mean change from baseline in PPG (mg/dL) -30 -40 -50 -60 -70 6-week, multicenter, parallel-design, double-blind, part-randomized, placebo-controlled, multiple-dose, phase 1 study in patients 65 years old with type 2 diabetes treated with oral antihyperglycemic medications except sulfonylureas, disaccharidase inhibitors, and meglitinides. Study arms included placebo (n=8); Trulicity 0.5 mg (n=9), not a marketed dose; Trulicity 0.75 mg (n=11); and Trulicity 1.5 mg (n=9). Primary objective was to evaluate the safety and tolerability of Trulicity 0.5 mg, 0.75 mg, and 1.5 mg for 6 weeks; mixed effect linear model; primary objective met. Data presented are secondary endpoints and show change in 2-hour postprandial plasma glucose concentration 48 hours after the first dose of Trulicity. Note to Speaker: This slide is animated. Main Point Once-weekly Trulicity reduced 2-hour postprandial glucose levels1 Additional Points2 6-week, multicenter, parallel-design, double-blind, part-randomized, placebo-controlled, multiple-dose, phase 1 study in patients 65 years old with type 2 diabetes treated with OAMs except sulfonylureas, disaccharidase inhibitors, and meglitinides Study arms included placebo (n=8); Trulicity 0.5 mg (n=9), not a marketed dose; Trulicity 0.75 mg (n=11); and Trulicity 1.5 mg (n=9) Primary objective was to evaluate the safety and tolerability of Trulicity 0.5 mg, 0.75 mg, and 1.5 mg for 6 weeks; mixed effect linear model; primary objective met Data presented are secondary endpoints and show change in 2-hour postprandial plasma glucose concentration 48 hours after the first dose of Trulicity References Trulicity [Prescribing Information]. Indianapolis, IN: Lilly USA, LLC; 2015. Data on file, Lilly USA, LLC. TRU F. Select Important Safety Information: Trulicity slows gastric emptying, which may impact absorption of concomitantly administered oral medications. Use caution when oral medications are administered with Trulicity. Monitor drug levels of oral medications with a narrow therapeutic index when concomitantly administered. In clinical pharmacology studies, Trulicity did not affect the absorption of the tested, orally administered medications to a clinically relevant degree. PPG = postprandial glucose. 1. Data on file, Lilly USA, LLC. TRU F. 2. Trulicity [Prescribing Information]. Indianapolis, IN: Lilly USA, LLC; 2015.

Adverse reactions in placebo-controlled studies through 26 weeks, reported in 5% of Trulicity-treated patients Trulicity 1.5 mg (N=834) Trulicity 0.75 mg (N=836) Placebo (N=568) Adverse reaction (through 26 weeks) Nausea (%) 5.3 12.4 21.1 Vomiting (%)* 2.3 6.0 12.7 Diarrhea (%)* 6.7 8.9 12.6 Abdominal pain (%)* 4.9 6.5 9.4 Decreased appetite (%) 1.6 8.6 Dyspepsia (%) 4.1 5.8 Fatigue (%)* 2.6 4.2 5.6 Main Points The chart shows adverse reactions reported in 5% of Trulicity-treated patients across placebo-controlled studies through 26 weeks Percentages reflect the number of patients that reported at least 1 treatment-emergent occurrence of the adverse reaction Adverse reactions in placebo‐controlled studies through 26 weeks, reported in 5% of Trulicity‐treated patients, were nausea, vomiting, diarrhea, abdominal pain, decreased appetite, dyspepsia, and fatigue Additional Points In the pool of placebo-controlled trials, gastrointestinal adverse reactions occurred more frequently among patients receiving Trulicity than placebo (placebo 21.3%, 0.75 mg 31.6%, 1.5 mg 41.0%); more patients receiving Trulicity 0.75 mg (1.3%) and Trulicity 1.5 mg (3.5%) discontinued treatment due to gastrointestinal adverse reactions than patients receiving placebo (0.2%) Concomitant therapies included metformin, sulfonylurea, TZDs, and mealtime insulin with or without metformin Reference Trulicity [Prescribing Information]. Indianapolis, IN: Lilly USA, LLC; 2015. *Adverse reaction term represents 1 preferred MedDRA terms, clustered under a single, common term. Note: Percentages reflect the number of patients that reported at least 1 treatment-emergent occurrence of the adverse reaction. Select Important Safety Information: Pancreatitis has been reported in clinical trials. Observe patients for signs and symptoms including persistent severe abdominal pain. If pancreatitis is suspected discontinue Trulicity promptly. Do not restart if pancreatitis is confirmed. Consider other antidiabetic therapies in patients with a history of pancreatitis. Trulicity [Prescribing Information]. Indianapolis, IN: Lilly USA, LLC; 2015.

Common side effects your patient may experience
The most common adverse reactions in clinical trials were GI in nature GI events were usually reported as mild or moderate Discontinuation rates due to GI adverse reactions 32% for 0.75 mg 93% for 0.75 mg 1.3% for 0.75 mg 41% for 1.5 mg 90% for 1.5 mg 3.5% for 1.5 mg 21% for placebo N/A 0.2% for placebo Main Point GI adverse reactions were usually reported as mild to moderate1 Additional Points In placebo‐controlled trials, GI side effects among patients receiving Trulicity 0.75 mg, 1.5 mg, and placebo were 32%, 41%, and 21%, respectively1 Of patients who reported GI side effects, 58% and 48% reported them as mild and 35% and 42% reported them as moderate at the Trulicity 0.75 mg and 1.5 mg doses, respectively1 Discontinuation rates due to GI adverse reactions were 1.3% for 0.75 mg and 3.5% for 1.5 mg1 Discontinuation rates due to nausea were 1.0% for 0.75 mg and 1.9% for 1.5 mg2 Nausea rates across clinical trials were 8% to 18% at the 0.75 mg dose and 15% to 29% at the 1.5 mg dose3 References Trulicity [Prescribing Information]. Indianapolis, IN: Lilly USA, LLC; 2015. Data on file, Lilly USA, LLC. TRU B. Data on file, Lilly USA, LLC. TRU A. Select Important Safety Information: There have been postmarketing reports of acute renal failure and worsening of chronic renal failure, sometimes requiring hemodialysis, in patients treated with GLP-1 receptor agonists. A majority of reported events occurred in patients who had experienced nausea, vomiting, diarrhea, or dehydration. In patients with renal impairment, use caution when initiating or escalating doses of Trulicity and monitor renal function in patients experiencing severe adverse gastrointestinal reactions. Use of Trulicity may be associated with gastrointestinal adverse reactions, sometimes severe. Trulicity has not been studied in and is not recommended for patients with a history of severe gastrointestinal disease (eg, severe gastroparesis). Trulicity [Prescribing Information]. Indianapolis, IN: Lilly USA, LLC; 2015.

When patients need additional A1C control, consider adding Trulicity along with diet and exercise
Trulicity offers your patients1 Once-weekly dosing The Trulicity pen Proven glycemic control* Recommended starting dose is 0.75 mg. Dose can be increased to 1.5 mg for additional glycemic control. Main Points Trulicity is an option for your adult patients with type 2 diabetes who need more control than oral medications are providing Trulicity is a GLP-1 RA therapy that offers once-weekly dosing, an easy-to-use pen, and proven glycemic control1,2 References Trulicity (dulagutide) [Prescribing Information]. Indianapolis, IN: Lilly USA, LLC; 2015. Trulicity [Instructions for Use]. Indianapolis, IN: Lilly USA, LLC; 2014. *In clinical studies, the range of A1C reduction from baseline was 0.7% to 1.6% for the 0.75 mg dose and 0.8% to 1.6% for the 1.5 mg dose; the percentage of patients achieving A1C 7% ranged from 37% to 69% for 0.75 mg and 53% to 78% for 1.5 mg.1-5 Select Important Safety Information: Trulicity is contraindicated in patients with a personal or family history of medullary thyroid carcinoma or in patients with Multiple Endocrine Neoplasia syndrome type 2. 1. Trulicity [Prescribing Information]. Indianapolis, IN: Lilly USA, LLC; Dungan KM et al. Lancet. 2014;384: Umpierrez G. et al. Diabetes Care. 2014;37: Giorgino F, et al. Presented at: American Diabetes Association Conference; San Francisco, CA: June 13-17, Jendle J, et al. Presented at: American Diabetes Association Conference; San Francisco, CA; June 13-17, 2014.

Designed with your patients in mind1-3
Trulicity offers Once-weekly dosing No reconstitution required Hidden 29-gauge needle4 No need to dial a dose In a study of 128 patients, caregivers, and healthcare providers, most people agreed the Trulicity pen was overall easy to use.5 Easy to use 94% Note to Speaker: This slide is animated. Main Points1-3 For patients who may be reluctant to start injectable therapy, Trulicity offers Once-weekly dosing No reconstitution required Hidden 29-gauge needle4 No need to dial a dose Additional Points5 People with type 2 diabetes, caregivers of people with diabetes, and healthcare professionals who treat diabetes participated in a study on the safe and effective use of the Trulicity pen and the instructions for the Trulicity pen 128 people completed a questionnaire on their experience using the pen and the instructions; one of the questions asked in the questionnaire included, “overall easy to use the medication delivery device” 94% of the people who used the Trulicity pen said it was easy to use References Trulicity [Prescribing Information]. Indianapolis, IN: Lilly USA, LLC; 2015. Trulicity [Instructions for Use]. Indianapolis, IN: Lilly USA, LLC; 2014. Glaesner W, Vick AM, Millican R, et al. Engineering and characterization of the long-acting glucagon-like peptide-1 analogue LY , an Fc fusion protein. Diabetes Metab Res Rev. 2010;26(4): Data on file, Lilly USA, LLC. TRU A. Data on file, Lilly USA, LLC. TRU L. Select Important Safety Information: Safety and effectiveness of Trulicity have not been established in pediatric patients. It is not recommended for use in patients younger than 18 years. Please see Instructions for Use included with the pen. 1. Trulicity [Prescribing Information]. Indianapolis, IN: Lilly USA, LLC; Trulicity [Instructions for Use]. Indianapolis, IN: Lilly USA, LLC; Glaesner W, et al. Diabetes Metab Res Rev. 2010;26(4): Data on file, Lilly USA, LLC. TRU A. 5. Data on file, Lilly USA, LLC. TRU L.

Prescribing once-weekly Trulicity
There are 2 efficacious doses available The recommended starting dosage of Trulicity is 0.75 mg once a week For patients requiring additional glycemic control, the dosage may be increased to 1.5 mg once a week 0.75 mg dose [NDC: ] Recommended starting dose 1.5 mg dose [NDC: ] Should your patient need more glycemic control Note to Speaker: This slide is animated. Main Point Review the 2 efficacious doses of once-weekly Trulicity available for your patients Select Important Safety Information: There are no adequate and well-controlled studies of Trulicity in pregnant women. Use only if the potential benefit outweighs potential risk to the fetus. It is not known whether Trulicity is excreted in human milk. A decision should be made whether to discontinue nursing or to discontinue Trulicity, taking into account the importance of the drug to the mother. Trulicity [Prescribing Information]. Indianapolis, IN: Lilly USA, LLC; 2015.

Pregnancy: There are no adequate and well-controlled studies of Trulicity in pregnant women. Use only if potential benefit outweighs potential risk to fetus. Nursing Mothers: It is not known whether Trulicity is excreted in human milk. A decision should be made whether to discontinue nursing or to discontinue Trulicity, taking into account the importance of the drug to the mother. Pediatric Use: Safety and effectiveness of Trulicity have not been established and use is not recommended in patients less than 18 years of age. Please see accompanying Participant Guide for Prescribing Information, including Boxed Warning about possible thyroid tumors including thyroid cancer, and Medication Guide. Please see Instructions for Use included with the pen. DG HCP ISI 20APR2015 Note to Speaker: Please read Important Safety Information for once-weekly Trulicity™ (dulaglutide). Byetta® is a registered trademark of the AstraZeneca group of companies. Januvia® is a registered trademark of Merck & Co., Inc. Lantus® is a registered trademark of sanofi-aventis U.S. LLC. Trulicity™ is a trademark owned or licensed by Eli Lilly and Company, its subsidiaries or affiliates. Trulicity is available by prescription only. Victoza® is a registered trademark of Novo Nordisk A/S. Trulicity [Prescribing Information]. Indianapolis, IN: Lilly USA, LLC; 2015.

THANK YOU In the Participant Guide, please see Important Safety Information, including Boxed Warning about possible thyroid tumors including thyroid cancer, the Full Prescribing Information, and Medication Guide.

Appendix: overview of efficacy

Clinical trial program
Monotherapy 2-drug combinations 3-drug combinations Insulin Active Comparator Metformin ( mg) Januvia® (sitagliptin) 100 mg/d Victoza® (liraglutide) 1.8 mg/d Byetta® (exenatide) 10 mcg BID Lantus® (insulin glargine) Lantus Background therapy None (monotherapy) Met 1500 mg (titrated over 11-week lead-in) Met 1500 mg Met + Pio (maximally tolerated doses) Met + SU (maximally tolerated doses) Prandial insulin lispro (titrated to BG targets) ± met Primary objective Noninferiority of Trulicity 1.5 mg vs metformin on A1C change from baseline at 26 weeks Noninferiority of highest selected dose vs Januvia on A1C change from baseline at 52 weeks Noninferiority of Trulicity 1.5 mg vs Victoza on A1C change from baseline at Superiority of Trulicity 1.5 mg vs placebo on A1C change from baseline at Noninferiority of Trulicity 1.5 mg vs Lantus* on A1C change from baseline at Noninferiority of Trulicity 1.5 mg vs Lantus* on A1C change from baseline at Study design Randomized, double-blind study Randomized, placebo-controlled, double-blind study Randomized, open-label comparator study Randomized, placebo-controlled study with open-label assignments to Byetta or blinded assignment to Trulicity or placebo Randomized, open-label comparator study (double-blind with respect to Trulicity dose assignment) Randomized, open-label comparator study (double-blind with respect to Trulicity dose assignment) Trial AWARD-31 (N=807) AWARD-51 (N=972) AWARD-62 (N=599) AWARD-11 (N=976) AWARD-21 AWARD-41 (N=884) Main Point A summary of AWARD clinical trials is presented here; in our discussions today, we will focus primarily on AWARD-2, AWARD-5, and AWARD-6 Additional Points Planned/ongoing studies include the following REWIND: event-driven (~9800 patients) study to assess cardiovascular risk Phase 3b studies: AWARD-7 (head-to-head vs Lantus® [insulin glargine] in patients with chronic kidney disease), AWARD-8 (add-on to sulfonylurea), AWARD-9 (add-on to basal insulin) Study Background AWARD-1 Study1,2 AWARD-1 was a 52-week, randomized, placebo-controlled, phase 3 study (open-label assignment to Byetta® [exenatide BID] or blinded assignment to Trulicity or placebo) of adult patients with type 2 diabetes treated with maximally tolerated (1500 mg/day) metformin and pioglitazone (up to 45 mg/day) Primary objective was to demonstrate superiority of Trulicity 1.5 mg vs placebo on mean change in A1C from baseline at 26 weeks (-1.5% vs -0.5%; 95% CI [-1.2, -0.9] for a difference of -1.1%; multiplicity-adjusted 1- sided alpha level of 0.025; analysis of covariance using LOCF); primary objective met Secondary objectives were to examine change in A1C from baseline to 52 weeks, percentage of patients with A1C 7% or 6.5%, changes in central lab fasting serum glucose (FSG), 8-point self-monitored plasma glucose (SMPG) profiles, change in body weight, and β-cell and insulin sensitivity indices Byetta-treated patients received 5 µg BID for first 4 weeks and then 10 µg BID for remainder of study Baseline A1C=8.1% in each treatment group; baseline age=56 years for both Trulicity groups and 55 years for Byetta and placebo groups; baseline weight=96 kg for the Trulicity arms, 97 kg for the Byetta group, and 94 kg for the placebo group Lead-in period lasted up to 12 weeks, and previous OAMs were discontinued (except metformin and pioglitazone) Patients were uptitrated to maximally tolerated doses of metformin and pioglitazone At randomization, 86% of patients received 2500 mg/day of metformin and 45 mg/day of pioglitazone Patients were then stabilized for approximately 8 weeks prior to randomization, at which time A1C 6.5% was required for ongoing eligibility Patients who discontinued study drug due to an AE were allowed to remain in study for safety follow-up; add-on rescue therapy was allowed for patients who met prespecified criteria for severe, persistent hyperglycemia Patient disposition Intent-to-treat (ITT) population at randomization: Trulicity 1.5 mg n=279; Trulicity 0.75 mg n=280; Byetta n=276 (there were an additional 2 patients randomized to Byetta who did not receive study drug and were not included in the ITT population); placebo n=141 Discontinued at 26 weeks: Trulicity 1.5 mg n=19; Trulicity 0.75 mg n=17; Byetta n=26; placebo n=17 At 26 weeks, total hypoglycemia incidence rates were 10.4% with Trulicity 1.5 mg, 10.7% with Trulicity 0.75 mg, and 15.9% with Byetta (P=.007 Trulicity 1.5 mg vs Byetta) and 3.5% with placebo; no Trulicity-treated patients and 2 Byetta-treated patients reported severe hypoglycemia Most common GI AEs for Trulicity were nausea, vomiting, and diarrhea; events were mostly mild to moderate and transient AWARD-2 Study1,3 78‐week, randomized, open‐label comparator phase 3 study (double‐blind with respect to Trulicity dose assignment) of adult patients with type 2 diabetes treated with maximally tolerated metformin and glimepiride Lantus titration was based on SMPG utilizing an algorithm with a target of 100 mg/dL Primary objective was to demonstrate noninferiority of Trulicity 1.5 mg vs Lantus titrated to target on A1C change from baseline at 52 weeks (‐1.1% vs ‐0.6%, respectively; analysis of covariance using LOCF); primary objective met Baseline A1C was 8.1%; baseline age 57 years; baseline weight=86.3 kg Patients received 1500 mg/day of metformin and 4 mg/day of glimepiride during the lead-in period; the doses were titrated up to maximum tolerated dose, then remained stable for 6-8 weeks ITT population at randomization: N=807; Trulicity 1.5 mg n=273; Trulicity 0.75 mg n=272; Lantus n=262 The most common GI AEs were nausea, vomiting, and diarrhea AWARD-3 Study1,4 Although this was a monotherapy study, Trulicity is not recommended as a first-line therapy 52‐week, randomized, double‐blind, phase 3 study of adult patients with type 2 diabetes treated with monotherapy Primary objective was to demonstrate noninferiority of Trulicity 1.5 mg vs metformin on A1C change from baseline at 26 weeks (‐0.8% vs ‐0.6%, respectively; analysis of covariance using LOCF); primary objective met The secondary objectives were to compare A1C change from baseline at 52 weeks and the following measures at 26 and 52 weeks: percentage of patients achieving A1C 7% and 6.5%, central laboratory measured FSG, body weight change from baseline, 8-point SMPG profiles, and measures of β-cell function, insulin sensitivity, and fasting glucagon Treatment period was 26 weeks for the primary endpoint with an extension to 52 weeks Baseline A1C=7.6%, baseline age 55 to 56 years; baseline weight 92 to 93 kg OAMs were discontinued at the beginning of the lead-in period Patients received either an oral placebo and Trulicity or an injectable placebo and metformin ITT population at 26 weeks: N=807; Trulicity 1.5 mg n=269; Trulicity 0.75 mg n=270; metformin n=268 Discontinued at 26 weeks: Trulicity 1.5 mg n=36; Trulicity 0.75 mg n=28; metformin n=42 At 26 weeks, total hypoglycemia incidence was as follows: Trulicity 1.5 mg (12.3%), Trulicity 0.75 mg (11.1%), metformin (12.7%); no patients reported severe hypoglycemia The most common GI AEs were nausea, diarrhea, vomiting, decreased appetite, and constipation AWARD-4 Study1,5 52‐week, randomized, open‐label comparator phase 3 study (double‐blind with respect to Trulicity dose assignment) of adult patients with type 2 diabetes treated with insulin lispro Insulin lispro was titrated based on preprandial and bedtime glucose, and Lantus was titrated based on fasting glucose Primary objective was to demonstrate noninferiority of Trulicity 1.5 mg vs Lantus titrated to target on A1C change from baseline at 26 weeks (‐1.6% vs ‐1.4%, respectively; analysis of covariance using LOCF); primary objective met The secondary objective was to show noninferiority, then superiority of Trulicity 0.75 mg to Lantus on A1C change at 26 and superiority of Trulicity 1.5 mg to Lantus on A1C change at week 26 Patients received 1500 mg/day of metformin Baseline A1C=8.4% to 8.5%; weight 91 to 92 kg; age=59 to 60 years ITT population at 26 weeks: N=884; Trulicity 1.5 mg n=295; Trulicity 0.75 mg n=293; metformin n=296 Discontinued at 26 weeks: Trulicity 1.5 mg n=73; Trulicity 0.75 mg n=69; Lantus n=60 AWARD-5 Study1,6 104‐week, randomized, placebo‐controlled, double‐blind, phase 3 study of adult patients with type 2 diabetes treated with metformin 1500 mg/day Primary objective was to demonstrate noninferiority of Trulicity 1.5 mg vs Januvia® (sitagliptin) on A1C change from baseline at 52 weeks (‐1.1% vs ‐0.4%, respectively; difference of ‐0.7%; 95% CI [‐0.9, ‐0.5]; multiplicity‐adjusted 1‐sided alpha level of for noninferiority with 0.25% margin; analysis of covariance using LOCF); primary objective met The secondary objectives included noninferiority comparison of Trulicity 0.75 mg to Januvia at 52 weeks, superiority comparison of Trulicity 1.5 mg and 0.75 mg to placebo at 26 weeks and to Januvia at 52 weeks, percentage of patients achieving A1C 7% or 6.5%, change in fasting plasma glucose, change in body weight, and safety measures A1C changes for Trulicity 0.75 mg vs Januvia at 52 weeks were -0.9% vs -0.4% (difference of -0.5%; 95% CI [-0.6 to -0.3%]) P.025 Treatment period was 52 weeks for the primary endpoint with an extension to 104 weeks; after 26 weeks, all patients in the placebo arm transitioned to Januvia in a blinded fashion Baseline A1C 8.0 to 8.2%; baseline age=54 years in all active treatment groups and 55 in the placebo group; baseline weight=87 kg for Trulicity 1.5 mg and placebo and 86 kg for Trulicity 0.75 mg and Januvia No patients reported severe hypoglycemia The most common GI AEs were nausea, diarrhea, and vomiting AWARD-6 Study7 26‐week, randomized, open‐label comparator, phase 3 study of adult patients with type 2 diabetes treated with metformin 1500 mg/day Primary objective was to demonstrate noninferiority of Trulicity 1.5 mg vs Victoza® (liraglutide) 1.8 mg on A1C change from baseline at 26 weeks (‐1.42% vs ‐1.36%, respectively; difference of ‐0.06%; 95% CI [‐0.19, 0.07]; 2‐sided alpha level of 0.05 for noninferiority margin 0.4%; mixed model repeated measures analysis); primary objective met Primary objective of noninferiority for A1C reduction was met; secondary endpoint of superiority was not met According to product labeling, patients randomized to Victoza were initiated at 0.6 mg/day, uptitrated to 1.2 mg/day after week 1, and then to 1.8 mg/day after week 2 Baseline A1C=8.1% for both treatment groups; baseline age=57 years; baseline weight=94 kg Patients who could not tolerate the full dose of study drug were required to discontinue study drug but encouraged to remain in study to collect safety data; rescue therapy was initiated for patients who experienced prespecified thresholds of severe, persistent hyperglycemia ITT population at 26 weeks: Trulicity 1.5 mg n=299; Victoza 1.8 mg n=300 Discontinued at 26 weeks: Trulicity 1.5 mg n=30; Victoza 1.8 mg n=31 At 26 weeks, total hypoglycemia incidence = Trulicity 1.5 mg (9%), Victoza 1.8 mg (6%); no patients reported severe hypoglycemia The most common GI AEs were nausea, diarrhea, vomiting, dyspepsia and constipation References Trulicity [Prescribing Information]. Indianapolis, IN: Lilly USA, LLC; 2014. Wysham C, Blevins T, Arakaki R, et al. Efficacy and safety of dulaglutide added on to pioglitazone and metformin versus exenatide in type 2 diabetes in a randomized controlled trial (AWARD-1) [published correction appears in Diabetes Care. 2014;37:2895]. Diabetes Care. 2014;37: Giorgino F, Benroubi M, Sun J H, Zimmermann A G, Pechtner V. Efficacy and safety of once weekly dulaglutide versus insulin glargine in combination with metformin and glimepiride in type 2 diabetes patients (AWARD-2). Presented at: American Diabetes Association Conference; San Francisco, CA: June 13-17, 2014. Umpierrez G, Povedano ST, Manghi FP, Shurzinske L, Pechtner V. Efficacy and safety of dulaglutide monotherapy versus metformin in type 2 diabetes in a randomized controlled trial (AWARD-3). Diabetes Care ;37(8): Jendle J, Rosenstock J, Blonde L, Woo V, Gross J, Jiang H, Milicevic Z. Better glycemic control and less weight gain with once weekly dulaglutide versus once daily insulin glargine both combined with pre-meal insulin lisproin type 2 diabetes patients (AWARD-4). Presented at: American Diabetes Association Conference; San Francisco, CA; June 13-17, 2014. Nauck M, Weinstock RS, Umpierrez GE, Guerci B, Skrivanek Z, Milicevic Z. Efficacy and safety of dulaglutide versus sitagliptin after 52 weeks in type 2 diabetes in a randomized controlled trial (AWARD-5) Diabetes Care ;37(8): Dungan KM, Povedano ST, Forst T, et al. Once-weekly dulaglutide versus once-daily liraglutide in metformin- treated patients with type 2 diabetes (AWARD-6): a randomised, open-label, phase 3, non-inferiority trial [published correction appears in Lancet. 2014;384:1348]. Lancet. 2014;384: *Titrated to FPG target of 100 mg/dL. Met = metformin; Pio = pioglitazone; SU = sulfonylurea; BG = blood glucose. 1. Trulicity [Prescribing Information]. Indianapolis, IN: Lilly USA, LLC; Dungan KM, et al. Lancet. 2014;384(9951):

A1C reduction across trials at primary endpoint
Compared to Januvia®1-3 Add-on to metformin (52 weeks) Compared to Byetta®1,5 Add-on to metformin and pioglitazone (26 weeks) Compared to Lantus®1,6,7,8 Add-on to metformin and glimepiride (52 weeks) Compared to Victoza®4 Add-on to metformin (26 weeks) -1.10 -0.39 -0.87 -1.42 -1.36 -1.51 -1.30 -0.99 -0.46 -1.08 -0.76 -0.63 -0.2 -0.4 -0.6 -0.8 A1C change from baseline (%) -1.0 -1.2 -1.4 -1.6 -1.8 Trulicity (1.5 mg) (n=279; Baseline A1C: 8.1%) Trulicity (0.75 mg) (n=280; Baseline A1C: 8.1%) Byetta (10 mcg BID) (n=276; Baseline A1C: 8.1%) Placebo (n=141; Baseline A1C: 8.1%) Data represent LS mean±SE Trulicity (1.5 mg) (n=279; Baseline A1C: 8.1%) Trulicity (0.75 mg) (n=281; Baseline A1C: 8.2%) Januvia (100 mg) (n=273; Baseline A1C: 8.0%) Trulicity (1.5 mg) (n=299; Baseline A1C: 8.1%) Victoza (1.8 mg) (n=300; Baseline A1C: 8.1%) Trulicity (1.5 mg) (n=273; Baseline A1C: 8.2%) Trulicity (0.75 mg) (n=272; Baseline A1C: 8.1%) Lantus (n=262; Baseline A1C: 8.1%) Note to Speaker: This slide is animated. Main Point1,2 Across clinical trials, Trulicity provided A1C reduction from 0.7% to 1.6% when used in combination with orals or with prandial insulin Additional Points AWARD-5 Study1 The baseline A1C was 8.0 to 8.2%; the change from baseline in A1C at 52 weeks was -1.1% for Trulicity 1.5 mg, -0.9% for Trulicity 0.75 mg, and -0.4% for Januvia; Trulicity 1.5 mg mean difference -0.7% (95% CI: -0.9 to -0.5); multiplicity adjusted 1- sided P-value 0.001, for superiority of Trulicity compared to sitagliptin for both 0.75 and 1.5 mg AWARD-6 Study2 The baseline A1C was 8.1%; the change from baseline in A1C at 26 weeks was -1.42% for Trulicity 1.5 mg, -1.36% for Victoza; Trulicity 1.5 mg mean difference -0.06% (95% CI: to 0.07) (P.0001, noninferior to Victoza) AWARD-1 Study1 The baseline A1C was 8.1%; the change from baseline in A1C at 26 weeks was -1.5% for Trulicity 1.5 mg, -1.3% for Trulicity mg, -1.0% for Byetta, and -0.5% for placebo; Trulicity 1.5 mg mean difference -0.5% (95% CI: -0.7 to -0.4); multiplicity adjusted 1-sided P-value 0.001, for superiority of Trulicity compared to exenatide for both 0.75 and 1.5 mg AWARD-2 Study1 The baseline A1C was 8.1 to 8.2%; the change from baseline in A1C at 52 weeks was -1.1% for Trulicity 1.5 mg, -0.8% for Trulicity 0.75 mg, and -0.6% for Lantus References Trulicity [Prescribing Information]. Indianapolis, IN: Lilly USA, LLC; 2015. Dungan KM, Povedano ST, Forst T, et al. Once-weekly dulaglutide versus once-daily liraglutide in metformin-treated patients with type 2 diabetes (AWARD-6): a randomised, open-label, phase 3, non-inferiority trial. Lancet. 2014;384(9951): *In clinical studies, the range of A1C reduction from baseline was 0.7% to 1.6% for the 0.75 mg dose and 0.8% to 1.6% for the 1.5 mg dose.1,4 Select Important Safety Information: Systemic hypersensitivity reactions were observed in patients receiving Trulicity in clinical trials. Instruct patients who experience symptoms to discontinue Trulicity and promptly seek medical advice. 1. Trulicity [Prescribing Information]. Indianapolis, IN: Lilly USA, LLC; Data on file, Lilly USA, LLC. TRU A. 3. Data on file, Lilly USA, LLC. TRU B. 4. Dungan KM, et al. Lancet. 2014;384: Wysham C, et al. Diabetes Care. 2014;37: Giorgino F, et al. Presented at: American Diabetes Association Conference; San Francisco, CA: June 13-17, Data on file, Lilly USA, LLC. TRU A. 8. Data on file, Lilly USA, LLC. TRU A.

Patients may have the opportunity to lose weight while taking Trulicity to lower their A1C1
Compared to Januvia®1-3 Add-on to metformin (52 weeks) Compared to Victoza®4 Add-on to metformin (26 weeks) Compared to Byetta®1,5 Add-on to metformin and pioglitazone (26 weeks) Compared to Lantus®1,6-8 Add-on to metformin and glimepiride (52 weeks) -4.2 -2.9 +3.1 4 -2.9 +0.4 -2.4 +2.6 3 2 1 -3.3 -6.8 -6.0 -6.39 -7.96 -1 -2 -3 Mean weight change from baseline (lb) -4 -5 -6 -7 -8 -9 -10 Data represent LS mean±SE. Trulicity (1.5 mg) (n=279; Baseline weight: lb) Trulicity (0.75 mg) (n=280; Baseline weight: lb) Byetta (10 mcg BID) (n=276; Baseline weight: lb) Placebo (n=141; Baseline weight: lb) Trulicity (1.5 mg) (n=279; Baseline weight:190.7 lb) Trulicity (0.75 mg) (n=281; Baseline weight:188.5 lb) Januvia (100 mg) (n=273; Baseline weight:189.2 lb) Trulicity (1.5 mg) (n=299; Baseline weight: lb) Victoza (1.8 mg) (n=300; Baseline weight: lb) Trulicity (1.5 mg) (n=273; Baseline weight: lb) Trulicity (0.75 mg) (n=272; Baseline weight: lb) Lantus (n=262; Baseline weight: lb) Note to Speaker: Use this slide ONLY if slides 36 and 37 are reviewed first. This slide is animated. Main Point This slide demonstrates the weight change associated with Trulicity 1.5 mg and 0.75 mg across phase 3 trials1-5 Additional Points Weight loss was ~2.0 to 6.8 lb at the 1.5 mg dose1-5 Trulicity vs Januvia: the LS mean change from baseline in body weight at 52 weeks was -6.8 lb (-3.03 kg) for Trulicity 1.5 mg, -6.0 lb (-2.60 kg) for Trulicity 0.75 mg, and -3.3 lb (-1.53 kg) for Januvia2 Trulicity 1.5 mg vs Victoza 1.8 mg: the least-squares (LS) mean change from baseline in body weight at 26 weeks was lb (-2.90 kg) for Trulicity 1.5 mg and lb (-3.61 kg) for Victoza 1.8 mg; mean difference 1.57 lb (0.71 kg)1 Trulicity vs Byetta: the LS mean change from baseline in body weight at 26 weeks was -2.9 lb (-1.30 kg) for Trulicity 1.5 mg, 0.4 lb (0.20 kg) for Trulicity 0.75 mg, -2.4 lb (-1.07 kg) for Byetta, and 2.6 lb (1.24 kg) for placebo; Trulicity 1.5 mg mean difference vs Byetta -0.5 lb (-0.24 kg), Trulicity 0.75 mg mean difference vs Byetta 2.8 lb (1.27 kg)3 Trulicity vs Lantus: the LS mean change from baseline in body weight at week 52 was -4.2 lb (-1.87 kg) for Trulicity 1.5 mg, lb (-1.33 kg) for Trulicity 0.75 mg and 3.1 lb (1.44 kg) for Lantus5 References Dungan KM, Povedano ST, Forst T, et al. Once-weekly dulaglutide versus once-daily liraglutide in metformin-treated patients with type 2 diabetes (AWARD-6): a randomised, open-label, phase 3, non-inferiority trial. Lancet ;384(9951): Nauck M, Weinstock RS, Umpierrez GE, Guerci B, Skrivanek Z, Milicevic Z. Efficacy and safety of dulaglutide versus sitagliptin after 52 weeks in type 2 diabetes in a randomized controlled trial (AWARD-5). Diabetes Care. 2014;37(8): Wysham C, Blevins T, Arakaki R, et al. Efficacy and safety of dulaglutide added on to pioglitazone and metformin versus exenatide in type 2 diabetes in a randomized controlled trial (AWARD-1). Diabetes Care. 2014;37(8): Wysham C, Blevins T, Arakaki R, et al. Efficacy and safety of dulaglutide versus placebo and exenatide in type 2 diabetes (AWARD-1). Presented at: European Association for the Study of Diabetes 49th Annual Meeting; Barcelona, Spain: September 23-27, 2013. Giorgino F, Benroubi M, Sun J H, Zimmermann A G, Pechtner V. Efficacy and safety of once weekly dulaglutide versus insulin glargine in combination with metformin and glimepiride in type 2 diabetes patients (AWARD-2). Presented at: American Diabetes Association Conference; San Francisco, CA: June 13-17, 2014. Trulicity is not indicated for weight loss. In AWARD studies 1-5, weight change was a secondary endpoint. Mean weight change was -6.8 lb to lb at the 1.5 mg dose and -6.0 lb to +0.4 lb at the 0.75 mg dose1 Select Important Safety Information: There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with Trulicity or any other antidiabetic drug. 1. Trulicity [Prescribing Information]. Indianapolis, IN: Lilly USA, LLC; Data on file, Lilly USA, LLC. TRU A. 3. Data on file, Lilly USA, LLC. TRU A. 4. Dungan KM, et al. Lancet. 2014;384(9951): Wysham C, et al. Diabetes Care. 2014;37(8): Giorgino F, et al. Presented at: American Diabetes Association Conference; San Francisco, CA: June 13-17, 2014. 7. Data on file, Lilly USA, LLC. TRU B. 8. Data on file, Lilly USA, LLC. TRU A.

Back-up slides

Epidemiology and burden of diabetes in the US
DIABETES AFFECTS EVERY 19 SECONDS SOMEONE is DIAGNOSED WITH DIABETES2 29.1 MILLION OR ~1 IN 11 PEOPLE OF ALL AGES1 Diagnosed: 21.0 million 1.7 million 20 years of age newly diagnosed in 2012 In adults, type 2 diabetes accounts for ~90-95% of all diagnosed cases of diabetes Undiagnosed: 8.1 million ESTIMATED COSTS $245 BILLION IN 20121 Speaker Direction Limit discussion to 1 or 2 statements about the importance of effectively treating and managing type 2 diabetes Main Points In the US, diabetes affects 29.1 million people or 9.3% (~1 in 11 people) of the US population; this includes1 21.0 million diagnosed people (about 1.7 million people 20 years of age were newly diagnosed with diabetes in 2012) and 8.1 million undiagnosed people 11.2 million individuals 65 years of age (25.9% of all people in this age group) Average medical expenditures for people with diabetes were 2.3 times higher in 2012 than people without diabetes, causing $176 billion in direct medical costs; diabetes causes $69 billion in indirect costs, such as disability, work loss, and premature death1 In adults, type 2 diabetes accounts for approximately 90-95% of all diagnosed cases of diabetes1 Someone is diagnosed with diabetes every 19 seconds, or 32,000 people over the course of a week2 References Centers for Disease Control and Prevention. National Diabetes Statistics Report: Estimates of Diabetes and Its Burden in the United States, Atlanta, GA: Centers for Disease Control and Prevention, US Dept of Health and Human Services; 2014. American Diabetes Association. Diabetes by the Numbers. facts/diabetes-by-the-numbers.html. Updated October 24, Accessed May 5, 2015. Direct medical costs: $176 billion Indirect societal costs: $69 billion 1. Centers for Disease Control and Prevention. National Diabetes Statistics Report: Estimates of Diabetes and Its Burden in the United States, ADA. Diabetes by the Numbers. Updated October 24, Accessed May 5, 2015.

*Adapted from Inzucchi SE, et al. Diabetes Care. 2015;38(1):140-149.
American Diabetes Association/EASD general therapy recommendations in type 2 diabetes* Dual therapy Efficacy Hypo risk Weight Side effects Costs high moderate risk gain hypoglycemia low low risk gain edema, HF, fxs intermediate neutral rare Thiazolidinedione DPP-4 inhibitor Sulfonylurea Healthy eating, weight control, increased physical activity, and diabetes education If HbA1C target not achieved after ~3 months of monotherapy, proceed to 2-drug combination (order not meant to denote any specific preference—choice dependent on a variety of patient- and disease-specific factors): Metformin If HbA1c target not achieved after ~3 months of dual therapy, proceed to 3-drug combination (order not meant to denote any specific preference—choice dependent on a variety of patient- and disease-specific factors):: or or or or or TZD DPP-4-i GLP-1-RA Insulin SU If HbA1C target not achieved after ~3 months of triple therapy and patient (1) on oral combination, move to injectables; (2) on GLP-1-RA, add basal insulin; or (3) on optimally titrated basal insulin, add GLP-1-RA or mealtime insulin. In refractory patients consider adding TZD or SGLT2-i: Basal insulin or Monotherapy Triple therapy Combination injectable therapy loss GI GLP-1 receptor agonist GU, dehydration SGLT2 inhibitor highest high risk hypoglycemia variable Insulin (basal) Mealtime insulin + SGLT2-i neutral / loss GI / lactic acidosis + + + + + + + + + + + + + + + + + + Note: This slide is considered optional. Note to Speaker: The disclaimer “Trulicity has not been studied in combination with basal insulin” must be read. Main Point The 2012 American Diabetes Association/European Association for the Study of Diabetes (EASD) position statement focuses on individualizing treatment for each patient2 Additional Points1,2 In most patients, begin with lifestyle changes; metformin monotherapy is added at, or soon after, diagnosis (unless there are explicit contraindications) If the glycated hemoglobin (A1C) target is not achieved after ~3 months, consider one of the recommended treatment options combined with metformin: a sulfonylurea, thiazolidinedione (TZD), dipeptidyl peptidase-4 (DPP-4) inhibitor, GLP-1 receptor agonist (RA), or basal insulin The order in the chart is determined by historical introduction and route of administration and is not meant to denote any specific preference Choice is based on patient and drug characteristics, with the overriding goal of improving glycemic control while minimizing adverse reactions Shared decision making with the patient may help in the selection of therapeutic options Insulin is likely to be more effective than most other agents as a third-line therapy, especially when A1C is very high (eg, 9.0%) The therapeutic regimen should include some basal insulin before moving to more complex insulin strategies Safety Information3 Trulicity has not been studied in combination with basal insulin The risk of hypoglycemia is increased when Trulicity is used in combination with insulin secretagogues (eg, sulfonylureas) or insulin; consider lowering the dose of the insulin secretagogue or insulin to reduce the risk of hypoglycemia The most common adverse reactions, reported in 5% of patients treated with Trulicity are: nausea, diarrhea, vomiting, abdominal pain, and decreased appetite Trulicity is not indicated for weight loss; weight change was a secondary endpoint in clinical trials References Inzucchi SE, Bergenstal RM, Buse JB, et al. Management of hyperglycemia in type 2 diabetes, 2015: a patient-centered approach: update to a position statement of the American Diabetes Association (ADA) and the European Association for the Study of Diabetes. Diabetes Care. 2015; 38(1): Inzucchi SE, Bergenstal RM, Buse JB, et al. Management of hyperglycemia in type 2 diabetes: a patient-centered approach. Position statement of the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD) [published correction appears in Diabetes Care. 2013;36(2):490] Diabetes Care. 2012;35(6): Trulicity (dulagutide) [Prescribing Information]. Indianapolis, IN: Lilly USA, LLC; 2015. *Adapted from Inzucchi SE, et al. Diabetes Care. 2015;38(1): Trulicity™ has not been studied in combination with basal insulin. HbA1C = glycated hemoglobin; DPP-4-i = dipeptidyl peptidase-4 inhibitor; EASD = European Association for the Study of Diabetes; fxs = fractures; GU = genito-urinary infections; HF = heart failure; SU = sulfonylurea; TZD = thiazolidinedione. Inzucchi SE, et al. Diabetes Care. 2015;38(1):

Individualizing treatment goals in type 2 diabetes*
Usually not modifiable Low High Risks potentially associated with hypoglycemia and other drug adverse effects Disease duration Life expectancy Important comorbidities Established vascular complications Resources and support system Newly diagnosed Long-standing Long Short Absent Severe Readily available Less motivated, nonadherent, poor self-care capacities Limited Highly motivated, adherent, excellent self-care capacities Less stringent More stringent HbA1c 7% Potentially modifiable Patient attitude and expected treatment efforts PATIENT/DISEASE FEATURES few/mild few/mild Main Point A number of factors should be taken into consideration when setting goals and considering a treatment approach with your patients Additional Points Based on the clinical evidence, target A1C should be adjusted based on a number of factors; greater height of the triangle indicates increased clinical concern about the considered variable (and decreased stringency in choosing a target); algorithms may be used as guidelines, but each patient should be treated as an individual1 Greater concerns about a particular domain are represented by increasing height of the ramp; thus, characteristics/predicaments towards the left justify more stringent efforts to lower A1C, whereas those toward the right are compatible with less stringent efforts2 The order of the factors in the figure is not meant to represent their relative importance in setting glycemic targets1 More stringent goals (such as 6.5%) may be appropriate for selected individual patients if the goals can be achieved without significant hypoglycemia or other adverse reactions to treatment; appropriate patients may include those with short duration of diabetes, long life expectancy, and no significant cardiovascular disease3 Less stringent A1C goals (such as 8%) may be appropriate for patients with a history of severe hypoglycemia, limited life expectancy, advanced microvascular or macrovascular complications, or extensive comorbid conditions, as well as those with long-standing diabetes in whom the general goal is difficult to attain despite diabetes self-management education, appropriate glucose monitoring, and effective doses of multiple glucose- lowering agents, including insulin3 References Ismail-Beigi F, Moghissi E, Tiktin M, Hirsch IB, Inzucchi SE, Genuth S. Individualizing glycemic targets in type 2 diabetes mellitus: implications of recent clinical trials. Ann Intern Med. 2011;154(8): Inzucchi SE, Bergenstal RM, Buse JB, et al. Management of hyperglycemia in type 2 diabetes, 2015: a patient- centered approach: update to a position statement of the American Diabetes Association (ADA) and the European Association for the Study of Diabetes. Diabetes Care. 2015;38(1): American Diabetes Association. Standards of medical care in diabetes–2015. Diabetes Care 2015;38(suppl. 1):S33–S40. This approach is not designed to be applied rigidly but to be used as a broad construct to help guide clinical decisions. *Adapted from Inzucchi SE, et al. Diabetes Care. 2015;38(1): Inzucchi SE, et al. Diabetes Care. 2015;38(1):

Once-weekly Trulicity compared to Lantus® (insulin glargine): AWARD-21
Design: 78‐week, randomized, open‐label comparator phase 3 study (double‐blind with respect to Trulicity dose assignment) of adult patients with type 2 diabetes Primary outcome measure: A1C change from baseline at 52 weeks Randomization Primary time point Final time point Diabetes Duration Years (Mean) Metformin glimepiride + 9 Trulicity 1.5 mg 9 Trulicity 0.75 mg Safety follow-up 9 Insulin glargine Main Points1,2 Assessment of Weekly AdministRation of LY in Diabetes (AWARD)-2 was a 78‐week, randomized, open‐label comparator phase 3 study (double‐blind with respect to Trulicity dose assignment) of adult patients with type 2 diabetes treated with maximally tolerated metformin and glimepiride Lantus titration was based on FPG utilizing an algorithm with a target of 100 mg/dL Primary objective was to demonstrate noninferiority of Trulicity 1.5 mg vs Lantus titrated to target on A1C change from baseline at 52 weeks (‐1.1% vs ‐0.6%, respectively; analysis of covariance using LOCF); primary objective met Treatment period was 52 weeks for the primary endpoint with an extension to 78 weeks Mean daily glargine dose (U/day) was: 29 and 31 for 52 weeks and 78 weeks, respectively Note: During the lead-in period, metformin (1500 mg) and glimepiride (4 mg) were titrated up to maximum tolerated dose and then continued for the duration of the study. FPG target 100 mg/dL; Lantus dose, mean (U/day) = 29 and 31 for 52 and 78 weeks, respectively. References Giorgino F, Benroubi M, Sun J H, Zimmermann A G, Pechtner V. Efficacy and safety of once weekly dulaglutide versus insulin glargine in combination with metformin and glimepiride in type 2 diabetes patients (AWARD-2). Presented at: American Diabetes Association Conference; San Francisco, CA: June 13-17, 2014. Trulicity [Prescribing Information]. Indianapolis, IN: Lilly USA, LLC; 2015. Screening Lead-in Treatment period Follow-up -12-10 52 78 82 Weeks Recommended starting dose is 0.75 mg. Dose can be increased to 1.5 mg for additional glycemic control. In clinical studies, the range of A1C reduction from baseline was 0.7% to 1.6% for the 0.75 mg dose and 0.8% to 1.6% for the 1.5 mg dose.2,3 1. Giorgino F, et al. Presented at: American Diabetes Association Conference; San Francisco, CA: June 13-17, Trulicity [Prescribing Information]. Indianapolis, IN: Lilly USA, LLC; Dungan KM, et al. Lancet. 2014;384(9951):

Data represent LS mean ± SE.
Once-weekly Trulicity demonstrated A1C reduction from baseline in a study compared to Lantus®1 0.0 Lantus (n=262; Baseline A1C: 8.1%) Trulicity (0.75 mg) (n=272; Baseline A1C: 8.1%) Trulicity (1.5 mg) (n=273; Baseline A1C: 8.2%) -0.6 -0.8 -1.1 -0.2 -0.4 -0.6 Mean change in A1C (%) -0.8 -1.0 -1.2 Note to Speaker: This slide is animated. Main Point Both Trulicity and Lantus reduced A1C from baseline at 52 weeks Additional Points Mean baseline A1C was 8.2%, 8.1%, and 8.1% for Trulicity 1.5 mg, Trulicity 0.75 mg, and Lantus, respectively LS mean A1C changes at 52 weeks for Trulicity 1.5 mg vs Lantus were -1.1% vs -0.6% LS mean A1C change at 52 weeks for Trulicity 0.75 mg was -0.8% Reference Giorgino F, Benroubi M, Sun J H, Zimmermann A G, Pechtner V. Efficacy and safety of once weekly dulaglutide versus insulin glargine in combination with metformin and glimepiride in type 2 diabetes patients (AWARD-2). Presented at: American Diabetes Association Conference; San Francisco, CA: June 13-17, 2014. -1.4 Data represent LS mean ± SE. Recommended starting dose is 0.75 mg. Dose can be increased to 1.5 mg. In clinical studies, the range of A1C reduction from baseline was 0.7% to 1.6% for the 0.75 mg dose and 0.8% to 1.6% for the 1.5 mg dose.1,2 Select Important Safety Information: Safety and effectiveness of Trulicity have not been established in pediatric patients. It is not recommended for use in patients younger than 18 years. 1. Trulicity [Prescribing Information]. Indianapolis, IN: Lilly USA, LLC; Dungan KM, et al. Lancet. 2014;384:

Once-weekly Trulicity showed weight reduction compared to Lantus® at 52 weeks1-3
+3.1 4 Trulicity (1.5 mg) (n=273; Baseline weight: lb) Trulicity (0.75 mg) (n=272; Baseline weight: lb) Lantus (n=262; Baseline weight: lb) 3 2 1 -2.9 -4.2 -1 Mean weight change from baseline (lb) -2 -3 -4 -5 -6 Note to Speaker: This slide is animated. Main Points This slide demonstrates the weight change associated with Trulicity 1.5 mg and 0.75 mg compared to Lantus1 Trulicity vs Lantus: the LS mean change from baseline in body weight at week 52 was -4.2 lb (-1.9 kg) for Trulicity 1.5 mg, -2.9 lb (-1.3 kg) for Trulicity 0.75 mg, and 3.1 lb (1.4 kg) for Lantus1 Additional Point Trulicity is not indicated for weight loss; weight change was a secondary endpoint in clinical trials; mean weight change was -6.8 lb to -2.0 lb at the 1.5 mg dose and -6.0 lb to +0.4 lb at the 0.75 mg dose1,2 References Trulicity [Prescribing Information]. Indianapolis, IN: Lilly USA, LLC; 2015. Dungan KM, Povedano ST, Forst T, et al. Once-weekly dulaglutide versus once-daily liraglutide in metformin- treated patients with type 2 diabetes (AWARD-6): a randomised, open-label, phase 3, non-inferiority trial. Lancet. 2014;384(9951): -7 Data represent LS mean ± SE. Trulicity is not indicated for weight loss. In AWARD studies 1-5, weight change was a secondary endpoint. Mean weight change was lb to -2.0 lb at the 1.5 mg dose and -6.0 lb to +0.4 lb at the 0.75 mg dose.1 Select Important Safety Information: There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with Trulicity or any other antidiabetic drug. 1. Trulicity [Prescribing Information]. Indianapolis, IN: Lilly USA, LLC; Data on file, Lilly USA, LLC. TRU B. 3. Data on file, Lilly USA, LLC. TRU A.

Trulicity 1.5 mg (n=273) Trulicity™ 0.75 mg (n=272) Lantus (n=262) In a head-to-head study with Lantus®1-2 Add-on to metformin + glimepiride (52 weeks) Documented symptomatic (events/patient/year) 3.02 1.67 Severe hypoglycemia†, n (%) 2 (0.8) 0 (0.0) 2 (0.7) *For study description, see slide 43. Documented symptomatic hypoglycemia was defined as 70 mg/dL glucose threshold. †Severe hypoglycemia is defined as an episode requiring the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Trulicity is not indicated for weight loss. Recommended starting dose is 0.75 mg. Dose can be increased to 1.5 mg. In clinical studies, the range of A1C reduction from baseline was 0.7% to 1.6% for the 0.75 mg dose and 0.8% to 1.6% for the 1.5 mg dose.1,3 Main Point The table shows the incidence of documented symptomatic hypoglycemia (70 mg/dL glucose threshold), events per patient per year, and severe hypoglycemia in a head-to-head study with Lantus (add-on to metformin and glimepiride, 52 weeks) Additional Points Hypoglycemia occurred more frequently when Trulicity was used in combination with sulfonylurea or insulin Severe hypoglycemia occurred in 0% and 0.7% of patients when Trulicity 0.75 mg and 1.5 mg, respectively, were co-administered with a sulfonylurea; severe hypoglycemia occurred in 2.4% and 3.4% of patients when Trulicity 0.75 mg and 1.5 mg, respectively, were co-administered with prandial insulin Reference Trulicity [Prescribing Information]. Indianapolis, IN: Lilly USA, LLC; 2015. Select Important Safety Information: The risk of hypoglycemia is increased when Trulicity is used in combination with insulin secretagogues (eg, sulfonylureas) or insulin. Patients may require a lower dose of sulfonylurea or insulin to reduce the risk of hypoglycemia. 1. Trulicity [Prescribing Information]. Indianapolis, IN: Lilly USA, LLC; CA. 2. Data on file, Lilly USA, LLC. TRU B. 3. Dungan KM, et al. Lancet. 2014;384: 32

Getting your patients started on once-weekly Trulicity
Your patients should be aware of the safety and efficacy information for the product and be trained on proper injection technique. Get your patients off to a good start with the Trulicity sample pack. The pack includes: A savings card to help eligible commercially covered patients save money (pay as little as $25*) on their prescription Educational information so your patients have support once they are home and preparing for their first dose Two sample pens for your patients’ first two weeks on Trulicity Note to Speaker: This slide is animated. Main Point Review tips for getting patients started on once-weekly Trulicity *For each of your patient’s first 26 prescriptions, Lilly pays up to $150 per month depending on insurance coverage. Only for those who do not receive government reimbursement for their prescriptions. Other terms and restrictions apply.

This program is sponsored by and the speaker is presenting on behalf of Lilly USA, LLC. It is being presented consistent with FDA guidelines and is not.

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This program is sponsored by and the speaker is presenting on behalf of Lilly USA, LLC. It is being presented consistent with FDA guidelines and is not.

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Presentation on theme: "This program is sponsored by and the speaker is presenting on behalf of Lilly USA, LLC. It is being presented consistent with FDA guidelines and is not."— Presentation transcript:

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