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1 Bydureon® Educate By Expert toolkit
Scientific slides: Introduction to Type 2 diabetes and the unmet need Thank you for choosing to use these slides from the Bydureon® Educate By Expert toolkit to discuss Type 2 diabetes and its unmet need. To ensure the high quality and relevance of the content, this toolkit has been developed with the guidance and approval of an independent international editorial committee: Associate Professor Dr Javier Ampudia Blasco (Specialist in Endocrinology and Nutrition, Spain) Paul Dromgoole (Diabetes Specialist Nurse and Clinical Lecturer, UK) Gwen Hall (Diabetes Specialist Nurse, UK) Professor Stephan Jacob (Specialist in Endocrinology and Diabetes, Germany) Professor Kamlesh Khunti (Primary Care Diabetes and Vascular Medicine, UK) Dr Orville Kolterman (Senior Vice President and Chief Medical Officer, Amylin Pharmaceuticals, US) Date of preparation: Apri l ENDORSED Developed with the guidance and approval of an independent international editorial committee

2 Content guide These decks comprise a number of slides, arranged in story order. You may find that some slides are not relevant to your audience. Please hide these as you feel necessary Some slides are accompanied by a short sound bite video of an expert that you may wish to embed from the toolkit. These are marked with the ‘expert sound bite’ symbol All graphs have been created in PowerPoint to enable easy amends and translation HbA1c values and appropriate graphs include both DCCT (%) and IFFC (mmol/mol) units. Please delete where not appropriate for your market i Expert sound bite DCCT, Diabetes Control and Complications Trial; IFFC, International Federation of Clinical Chemistry and Laboratory Medicine.

3 Executive summary This slide deck covers the following topics and contains speaker notes to assist presentation: Introduction to Type 2 diabetes Unmet needs and barriers to treatment Epidemiology of Type 2 diabetes Barriers to treatment (weight gain, hypoglycaemia, adherence to treatment) The Type 2 diabetes treatment pathway and individualised care The place of GLP-1 receptor agonists and insulin in the treatment pathway GLP-1 receptor agonists and the discovery of exenatide GLP-1 mechanism of action and the incretin effect The discovery of exenatide, the first GLP-1 receptor agonist

4 Introduction to Type 2 diabetes: Unmet needs and barriers to treatment
<Insert speaker name>

5 The unmet needs in the management of Type 2 diabetes
The following slides provide an overview of the unmet need in Type 2 diabetes and the barriers to its effective treatment.

6 Approximately 53 million adults suffer from diabetes in Europe
8.1% of the adult population in Europe suffer from diabetes By 2030, the prevalence of diabetes in Europe is forecast to rise to 9.5% of the adult population Prevalence* of diabetes (20–79 years) in Europe, 2011 Main talking point: Diabetes is a growing concern in Europe, with prevalence forecast to increase in the coming decades and place increasing burden on healthcare systems. Reference The International Diabetes Federation. Diabetes Atlas, 5th edition (2011). Available at: Last accessed August 2013. Adapted from The International Diabetes Federation. Diabetes Atlas, 5th edition (2011). Available at: Last accessed August 2013.

7 The growing burden of Type 2 diabetes
Expert sound bite Placeholder for video 1Ai. Dr Javier Francisco Ampudia Blasco: The growing burden of Type 2 diabetes

8 Despite advances in treatment, a significant proportion of patients with Type 2 diabetes still fail to reach target HbA1c levels PANORAMA study (2009)2 Percentage of patients not achieving target HbA1c level: <7.0% (<53 mmol/mol) UK (n=501) France (n=759) Germany (n=808) Italy (n=752) Spain Nine EU countries (n=5817) Belgium (n=659) Netherlands (n=611) Greece (n=375) Turkey (n=600) Main talking point: There is still a significant unmet need in Type 2 diabetes, as many patients still fail to achieve HbA1c goals of <7% (<53 mmol/mol), which comes despite recent advances in treatments and the development of several new classes of antidiabetic agent. Notes: PANORAMA was a nine-country, observational, cross-sectional study of patients with Type 2 diabetes, aimed at assessing treatment satisfaction, quality of life and other patient-reported outcomes in relation to glycaemic control and treatment patterns2 The study enrolled 5817 patients from 9 countries (Belgium, France, Germany, Greece, Italy, the Netherlands, Spain, Turkey and the UK) References De Pablos-Velasco P, et al. Clin Endocrinol (Oxf) 2012; Epub ahead of print. Adapted from De Pablos-Velasco P, et al. Clin Endocrinol (Oxf) 2012; Epub ahead of print.

9 Type 2 diabetes as a progressive disease and its increasing unmet need
Expert sound bite Placeholder for video 1Aii. Professor Stephan Jacob: Type 2 diabetes as a progressive disease and its increasing unmet need

10 HbA1c levels (mmol/mol)
Traditional approaches to Type 2 diabetes management often have limited success Traditionally, Type 2 diabetes has been managed by a stepwise, conservative approach where regimens are changed only when symptoms become apparent In the majority of cases, this approach does not lead to sustained glycaemic control Duration of diabetes 9 8 7 6 HbA1c levels (%) 80 70 60 50 HbA1c levels (mmol/mol) + drug Complex insulin regimen 10 + basal insulin Diagnosis +5 years +10 years +15 years Diet Main talking point: Traditional management of Type 2 diabetes have focused on managing acute symptoms as they appear. This conservative approach often fails to support sustained glycaemic control. Reference Campbell IW. Br J Cardiol 2000;7:625–31. Adapted from Campbell IW. Br J Cardiol 2000;7:625–31.

11 Early, intensive interventions can support long-term glycaemic control
Adoption of an intensive, goal-focused strategy from diagnosis can improve long-term glycaemic control in Type 2 diabetes Any combination regimen should be well tolerated as well as efficacious, to promote adherence Duration of diabetes 9 8 7 6 HbA1c levels (%) 80 70 60 50 HbA1c levels (mmol/mol) Diet + drug Complex insulin regimen 10 + basal insulin Diagnosis +5 years +10 years +15 years Main talking point: Adoption of an approach that focuses on HbA1c goals and uses early interventions can improve long-term glycaemic control for patients. Reference Campbell IW. Br J Cardiol 2000;7:625–31. Adapted from Campbell IW. Br J Cardiol 2000;7:625–31.

12 Managing Type 2 diabetes through early interventions
Expert sound bite Placeholder for video 1Aiii. Professor Kamlesh Khunti: Managing Type 2 diabetes through early interventions

13 The barriers to effective treatment of Type 2 diabetes
Many barriers to effective treatment of Type 2 diabetes have been identified. These include: Weight gain, either from lifestyle or antidiabetic medication1 Rates and fear of hypoglycaemia, due to use of certain classes of antidiabetic therapies2 Poor adherence to therapy3 Clinical inertia around the progressive nature of Type 2 diabetes and eventual requirement for insulin4,5 Main talking point: The unmet need in Type 2 diabetes management is supported by four main barriers to treatment: Weight gain1 Hypoglycaemia2 Poor adherence to therapy3 Clinical inertia around the progressive nature of Type 2 diabetes and the likelihood that most patients will eventually require insulin replacement4,5 References UK Prospective Diabetes Study (UKPDS) Group. Lancet 1998;352:854–65. Amiel SA, et al. Diabet Med 2008;25:245–54. Guisasola AF. Diabetes Obes Metab 2008;10(Suppl. 1):25–32. Weyer C, et al. J Clin Invest 1999;104:787–94. Khunti K, et al. Diabetes Care 2013;36:3411–7. 1. UK Prospective Diabetes Study (UKPDS) Group. Lancet 1998;352:854–65; 2. Amiel SA, et al. Diabet Med 2008;25:245–54; 3. Guisasola AF. Diabetes Obes Metab 2008;10(Suppl. 1):25–32; 4. Weyer C, et al. J Clin Invest 1999;104:787–94; 5. Khunti K, et al. Diabetes Care 2013;36:3411–7.

14 Raising awareness of diabetes and its associated risk factors
Expert sound bite Placeholder for video 1Aiv. Paul Dromgoole: Raising awareness of diabetes and its associated risk factors

15 Diabetes and obesity are closely interlinked
100 75 50 25 <23 <23–23.9 <24–24.9 <25–26.9 <27–28.9 <29–30.9 <31–32.9 <33–34.9 ≥35 Normal weight Overweight Obese Women Men Age-adjusted relative risk for Type 2 diabetes BMI (kg/m2) Relationship between BMI and risk of Type 2 diabetes Main talking point: There is a strong association with obesity and the relative risk of developing Type 2 diabetes.1,2 References Chan J, et al. Diabetes Care 1994;17:961–9. Colditz GA, et al. Ann Intern Med 1995;122:481–6. *Results are from two different studies. The first study is from a cohort of 27,983 US male health professionals, 40–75 years of age in 1986 who completed biennial questionnaires sent out in 1986, 1988, 1990 and 1992 (follow-up: 1987–1992). The second study is from a cohort of 114,281 US female registered nurses, 30–55 years of age in 1976 who completed questionnaires (follow-up: 1976–1990). BMI, body mass index. Adapted from: 1. Chan J, et al. Diabetes Care 1994;17:961–9; 2. Colditz GA, et al. Ann Intern Med 1995;122:481–6.

16 Disease progression is associated with weight change
Baseline patient characteristics associated with diabetes progression* over the subsequent year (n=705) Clinical characteristics Non-progressors (n=505) Progressors (n=200) p value Baseline weight (kg) 84.9 ± 19.5 88.3 ± 24.4 0.16 Baseline BMI (kg/m2) 32 ± 6.9 32.3 ± 9.3 0.78 Change in weight (kg) –0.9 ± 7.5 0.2 ± 7.2 0.17 Baseline SBP (mmHg) 129.3 ± 17.6 127.9 ± 16.5 0.36 Baseline DBP (mmHg) 74.7 ± 11.3 73.8 ± 10.9 Main talking point: Weight gain after diagnosis is a strong, independent predictor of diabetes progression over the subsequent year. Notes: This study identified 5804 patients with Type 2 diabetes seen at least twice within a 12-clinic primary care network, and examined predictors of diabetes progression (HbA1c ≥7.0% [≥53.0 mmol/mol] or initiation of hypoglycaemic agent) over a 1-year follow-up period in 705 patients who had HbA1c ≥7.0% (≥53.0 mmol/mol) and were not on glucose-lowering medications at baseline In the 200 patients in this group who progressed, predictors of medical therapy initiation were examined Baseline HbA1c and younger age were also independent predictors of progression Progression was defined as HbA1c measurement of ≥7.0% (≥53.0 mmol/mol) or initiation of hypoglycaemic agent over the 1-year follow-up period Reference Pani LN, et al. Diabetes Care 2008;31:386–90. *HbA1c levels ≥7% or initiation of antidiabetic agent in patients with HbA1c <7.0% (<53.0 mmol/mol) and not on glucose-lowering medications at baseline. BMI, body mass index; DBP, diastolic blood pressure; SBP, systolic blood pressure. Pani LN, et al. Diabetes Care 2008;31:386–90.

17 In patients with Type 2 diabetes, weight loss provides multiple benefits: The Look AHEAD study
Odds ratio for the percentage of the Look AHEAD patient cohort achieving clinically meaningful changes in CVD risk factors at 1 year after a weight loss of ≥5% to <10% (n=1000/5145) Clinical criteria Odds ratio 95% CI 0.05% in HbA1c 3.52 2.81, 4.40 5 mmHg in SBP 1.56 1.27, 1.91 5 mmHg in DBP 1.48 1.20, 1.82 5 mg/dL in HDL cholesterol 1.69 1.37, 2.07 40 mg/dL in triglycerides 2.20 1.71, 2.83 Main talking point: Weight loss offers multiple benefits to both HbA1c and CV risk factors in patients with Type 2 diabetes. Notes: This study was an observational analysis of participants in the Look AHEAD (Action for Health in Diabetes) study conducted at 16 US sites in 5145 patients with Type 2 diabetes (40.5% male, 37% from ethnic/racial minorities). Its objective was to examine the association between the magnitude of weight loss and changes in CVD risk factors at 1 year and the odds of meeting predefined criteria for clinically relevant improvements in risk factors The magnitude of weight loss at 1 year was strongly (p<0.0001) associated with improvements in glycaemia, blood pressure, triglycerides, and HDL cholesterol, but not in LDL cholesterol (p=0.79) Compared with weight-stable participants, those who lost 5 to <10% of their body weight had increased odds of achieving an HbA1c reduction of 0.5%; a DBP reduction of 5 mmHg; a SBP reduction of 5 mmHg; a HDL increase of 5 mg/dL; and a triglyceride reduction of 40 mg/dL The odds of clinically significant improvements in most risk factors were even greater in those who lost 10–15% of their body weight CV, cardiovascular; CVD, cardiovascular disease; DBP, diastolic blood pressure; HDL, high-density lipoprotein; LDL, low-density lipoprotein; SBP, systolic blood pressure. Reference Wing RR, et al. Diabetes Care 2011;34:1481–6. This study was an observational analysis of participants in the Look AHEAD study conducted at 16 US sites in 5,145 participants (40.5% male, 37% from ethnic/racial minorities). AHEAD, Action for Health Diabetes; CI, confidence interval; CVD, cardiovascular disease; DBP, diastolic blood pressure; HDL, high-density lipoprotein, SBP, systolic blood pressure. Wing RG, et al. Diabetes Care 2011;34:1481–6.

18 Many current therapies are associated with hypoglycaemia
During the UKPDS, self-reported hypoglycaemic symptoms were graded using a four-point scale: Transitory symptoms not affecting normal activity Temporarily incapacitated but patient able to control symptoms without help Incapacitated and required assistance to control symptoms Required medical attention or glucagon injection Therapy n* Annual percentage of patients reporting at least one hypoglycaemic episode, % (95% CI) Grades 1–4 Grades 2–4 Diet 756 0.8 (0.6 to 1.0) 0.1 (0.1 to 0.2) SU 1418 7.9 (5.1 to 11.9) 1.2 (0.4 to 3.4) Metformin 290 1.7 (1.0 to 3.0) 0.3 (0.1 to 1.1) Basal insulin 1036 21.2 (14.6 to 29.8) 3.8 (1.2 to 11.1) Basal + prandial insulin 38 32.6 (21.8 to 45.6) 5.5 (2.0 to 14.0) Main talking point: SUs and insulin associated with a higher risk of hypoglycaemia than metformin. Notes: Hypoglycaemia is less common in people with Type 2 diabetes than in those with Type 1 diabetes; however, hypoglycaemia becomes progressively more frequent later in the course of Type 2 diabetes (advanced disease) and approaches the frequency observed in Type 1 diabetes1 The UKPDS reports annual percentages of patients reporting hypoglycaemia, irrespective of current therapy. For Grade 2–4 episodes, these were lowest in those on diet (0.1%) and metformin (0.3%), higher on SUs (1.2%) and highest on insulin. A higher but not statistically significant proportion of patients taking basal + soluble insulin reported Grade 2–4 hypoglycaemic episodes (5.5% [95% CI, 2.0 to 14.0]) than those on basal insulin alone (3.8% [95% CI, 1.2 to 11.1]), irrespective of achieved glycaemic control2 The proportion of patients reporting Grade 1–4 hypoglycaemia was lowest in those treated with diet (0.8%) followed by metformin (1.7%) and SU (7.9%) but appeared to increase in insulin-treated patients (basal insulin, 21.2%; basal + prandial insulin, 32.6%)2 CI, confidence interval; SU, sulphonylurea; UKPDS, UK Prospective Diabetes Study. References Cryer PE. Diabetes 2008;57:3169–76. Wright AD, et al. J Diabetes Complications 2006;20:395–401. *Patients taking assigned therapy over 6 years’ follow-up. CI, confidence interval; SU, sulphonylurea; UKPDS, UK Prospective Diabetes Study. Wright AD, et al. J Diabetes Complications 2006;20:395–401.

19 Severe hypoglycaemia is associated with poor CV outcomes and mortality
ADVANCE study No. of patients with events (%) Events Severe hypoglycaemia (n=231) No severe hypoglycaemia (n=10,909) HR (95% CI) Major macrovascular events Unadjusted model Adjusted model 33 (15.9) 1114 (10.2) 4.05 (2.86 to 5.74) 3.53 (2.41 to 5.17) Major microvascular events 24 (11.5) 1107 (10.1) 2.39 (1.60 to 3.59) 2.19 (1.40 to 3.45) Death from any cause 45 (19.5) 986 (9.0) 4.86 (3.60 to 6.57) 3.27 (2.29 to 4.65) Death from CV cause 22 (9.5) 520 (4.8) 4.87 (3.17 to 7.49) 3.79 (2.36 to 6.08) Death from non-CV cause 23 (10.0) 466 (4.3) 4.82 (3.16 to 7.35) 2.80 (1.64 to 4.79) Main talking point: A severe hypoglycaemic episode is associated with a greater CV risk including that of macrovascular events, microvascular events, and death from CV and any cause. Notes: The ADVANCE study was conducted in 11,140 patients with Type 2 diabetes and a history of major macrovascular or microvascular disease or at least one other CV risk factor. Patients were assigned to one of two treatment regimens: Intensive glycaemic control (the SU gliclazide + other antidiabetic agents as required; target HbA1c ≤6.5% [≤47.5 mmol/mol]) Standard glycaemic control (guideline-based glucose lowering) The primary clinical outcomes were the first major macrovascular event and the first major microvascular event. Secondary outcomes were death from any cause and death from a CV event CV, cardiovascular. Reference Zoungas S, et al. N Engl J Med 2010;363:1410–8. The HR represents the risk of an adverse clinical outcome or death among patients reporting severe hypoglycaemia compared with those not reporting severe hypoglycaemia. CI, confidence interval; CV, cardiovascular; CVD, cardiovascular disease; HR, hazard ratio. Zoungas S, et al. N Engl J Med 2010;363:1410–8.

20 The costs of severe hypoglycaemia
The cost implications of severe hypoglycaemia, both direct hospital costs and indirect costs due to inability to work, are considerable1,2 There is evidence to suggest that people with Type 2 diabetes lose, on average, 3 productive days following a severe hypoglycaemic attack1 Inpatient costs are consistently higher than outpatient costs, due to increased medical care for diabetes-related complications3 Cost per severe hypoglycaemic event (year 2007)2 Country Average patient with Type 2 diabetes Patient requiring hospitalisation Germany €533 €3023 Spain €691 €1404 UK €537 €1314 Main talking point: Hypoglycaemia presents a significant cost, both directly to the healthcare system and indirectly due to inability to work.1,2 Discussion: Hospitalisation greatly increases the cost of hypoglycaemia.2 Outpatient care and diabetes medication can be less than half of inpatient costs due to the relatively low costs of maintaining good glycaemic control via medication and regular monitoring3 The presence of complications, particularly multiple complications, can multiply diabetes costs by several times3 Diabetes drug costs are the smallest component of overall diabetes-related expenditure (between 6.2% [France, Italy] and 10.5% [Spain] of overall spend), whereas non-diabetes medications cost 3–4 times that of diabetes medications, in particular CV medications3 CV, cardiovascular. References: Amiel SA, et al. Diabet Med 2008;25:245–54. Hammer M, et al. J Med Econ 2009;12:281–90. Kanavos P, et al Available at: lsehealthandsocialcare/research/lsehealth/mtrg/lsediabetesreport26jan2012.pdf. Last accessed August 2013. 1. Amiel SA, et al. Diabet Med 2008;25:245–54; 2. Hammer M, et al. J Med Econ 2009;12:281–90; 3. Kanavos P, et al Available at: Last accessed June 2013.

21 Quality of life issues: Patient fear regarding hypoglycaemia
Fear of hypoglycaemia:1 Is an additional psychological burden on patients May limit the aggressiveness of drug therapy Can decrease adherence to treatment recommendations May reduce compliance with therapy Fear of hypoglycaemia can influence: Patient health outcomes (prevention or delay of diabetes-related complications)2 Post-episode lifestyle changes2 A severe hypoglycaemic event can increase fear of hypoglycaemia in the future3 Main talking point: Fear of hypoglycaemia can limit patient adherence to and effectiveness of antidiabetic therapy, and negatively impact on quality of life.1,2 References Leiter LA, et al. Can J Diab 2005;29:186–92. Davis S, et al. J Diab Comp 2004;18:60–8. 1. Leiter LA, et al. Can J Diab 2005;29:186–92; 2. Davis S, et al. J Diab Comp 2004;18:60–8; 3. Currie CJ, et al. Curr Med Res Opin 2006;22:1523–34.

22 Hypoglycaemia is a cause of lifestyle modifications in patients with Type 2 diabetes
Main talking point: Hypoglycaemic episodes are likely to increase fear of future hypoglycaemia and prompt lifestyle changes in patients with Type 2 diabetes. Reference Leiter LA, et al. Can J Diab 2005;29:186–92. Graph shows patients (n=202) who ‘sometimes’ or ‘always’ made lifestyle changes within 24 hours of a hypoglycaemic episode, in a self-administered questionnaire. Mild/moderate hypoglycaemia, plasma glucose ≤4.0 mol/L; severe hypoglycaemia, plasma glucose <2.8 mmol/L and requiring assistance. Adapted from Leiter LA, et al. Can J Diab 2005;29:186–92.

23 The requirement for more intelligent compounds such as the incretin-based agents
Expert sound bite Placeholder for video 1Av. Professor Stephan Jacob: The requirement for more intelligent compounds such as the incretin-based agents

24 Many patients with diabetes do not adhere to their treatment
Poor patient adherence to treatment is an important barrier to glycaemic control1 Retrospective studies in people with Type 2 diabetes reported adherence rates of 36–93% for oral agents and 62–64% for insulin1 Therapy persistence has been shown to decrease with time, and with polytherapy compared with monotherapy2 Persistent patients (%) 100 80 60 40 20 Week Metformin monotherapy SU monotherapy Metformin + SU polytherapy Main talking point: Patient adherence to antidiabetic medication declines over time and presents an important barrier to effective treatment. References Cramer JA. Diabetes Care 2004;27:1218–24. Dailey G, et al. J Int Med Res 2002;30:71–9. Figure from Dailey et al.2 SU, sulphonylurea. 1. Cramer JA. Diabetes Care 2004;27:1218–24; 2. Dailey G, et al. J Int Med Res 2002;30:71–9.

25 Clinical inertia can lead to poor glycaemic control in patients with Type 2 diabetes
Clinical inertia is the failure to intensify treatment in a timely manner There is a delay in intensifying treatment in people with Type 2 diabetes with poor glycaemic control, which leads to prolonged periods of hyperglycaemia Patients may remain in poor glycaemic control for over 7 years before intensification of treatment with insulin In patients taking 1 or 2 OADs, median time from initiation of treatment to intensification with an additional OAD exceeded the study’s maximum follow-up time of 7.3–7.3 years Main talking point: Clinical inertia is the failure to intensify treatment in a timely manner, which can lead to prolonged periods of hyperglycaemia and contribute towards patients’ failure to achieve glycaemic targets. Notes: This was a retrospective cohort analysis investigated the time to intensification of treatment in people with Type 2 diabetes treated with OADs, and the associated levels of glycaemic control, and compared them with recommended treatment guidelines for diabetes Used the Clinical Practice Research Datalink database, which represents the primary care longitudinal records of >13 million patients across the UK (81,753 included in this analysis) Period covered: January 2004 to December 2006 with follow-up to April 2011 (maximum follow-up time: 7.3 years) Primary endpoint: Time to intensification of treatment from the time of being in poor control (defined as HbA1c ≥7.0% [≥53.0 mmol/mol], ≥7.5% [≥58.5 mmol/mol] and ≥8.0% [≥63.9 mmol/mol]) Treatment intensification was defined as either addition of further OAD prescription without changes in current OAD prescription, or initiation of insulin irrespective of changes in OAD regimen OAD, oral antidiabetic drug. Reference Khunti K, et al. Diabetes Care 2013;36:3411–7. Treatment intensification was defined as either addition of further OAD prescription without changes in current OAD prescription, or initiation of insulin irrespective of changes in OAD regimen. OAD, oral antidiabetic drug. Khunti K, et al. Diabetes Care 2013;36:3411–7.

26 Requirements for aggressive antidiabetic treatment beyond diet and exercise
Expert sound bite Placeholder for video 1Avi. Professor Kamlesh Khunti: Requirements for aggressive antidiabetic treatment beyond diet and exercise

27 The Type 2 diabetes treatment pathway and individualised care
The following slides discuss the importance of an individualised approach to the management of Type 2 diabetes, in the context of the treatment pathway.

28 ADA/EASD 2012 position statement on the management of Type 2 diabetes
Key points: Glycaemic targets and glucose-lowering therapies must be individualised HbA1c <7% (<53 mmol/mol) for most patients More stringent (e.g. 6.0–6.5% [42.1–47.5 mmol/mol]) and less stringent HbA1c targets might be considered in selected patients Diet, exercise, and education remain key All treatment decisions should be made in conjunction with the patient, focusing on his/her preferences, needs and values Comprehensive CV risk reduction must be a major focus of therapy Additional considerations include: Age, weight, sex/racial/ethnic/genetic differences and comorbidities “An approach to providing care that is respectful of and responsive to individual patient preferences, needs, and values and ensuring that patient values guide all clinical decisions.” – ADA/EASD position statement 2012 Main talking point: The recent joint position statement published by the ADA and EASD states that it is important to individualise glycaemic targets and medication in patients with Type 2 diabetes, in order to achieve the optimal balance between glycaemic control, risk of comorbidities and quality of life. ADA, American Diabetes Association; EASD, European Association for the Study of Diabetes. Reference Inzucchi SE, et al. Diabetes Care 2012;35:1364–79. ADA, American Diabetes Association; CV, cardiovascular; EASD, European Association for the Study of Diabetes. Inzucchi SE, et al. Diabetes Care 2012;35:1364–79.

29 Avoiding side effects of treatment with antidiabetic agents
Expert sound bite Placeholder for video 1Avii. Paul Dromgoole: Avoiding side effects of treatment with antidiabetic agents

30 Individualisation of treatment goals is key
Approach to management of hyperglycaemia More stringent Less stringent Risks potentially associated with hypoglycaemia and other adverse events Disease duration Life expectancy Important comorbidities Established vascular complications Resources, support system High Low Newly diagnosed Long-standing Long Short Absent Severe Readily available Limited Few/mild Main talking point: There are a number of factors that should be taken into consideration when deciding with a patient the stringency of their glycaemic targets.1 Notes: The diagram depicts elements to consider when making decisions around HbA1c targets for specific patients. This scale is not designed to be applied rigidly, but to serve as a broad framework to assist in determining the stringency of glycaemic targets1 Additional treatment considerations are becoming increasingly common in patients with Type 2 diabetes, as the age of diagnosis decreases at the same time as the population ages1–3 this emphasises the importance of individualised care3 References Bays HE, et al. SHIELD Study Available at: Last accessed August 2013. Inzucchi SE, et al. Diabetes Care 2012;35:1364–79. Koopman RJ, et al. Ann Fam Med 2005;3;60–3. The figure depicts elements to consider when making decisions about HbA1c targets for specific patients. The scale is not designed to be applied rigidly but to serve as a broad framework to assist in determining glycaemic targets. Adapted from: Inzucchi SE, et al. Diabetes Care 2012;35:1364–79.

31 Antihyperglycaemic therapy in Type 2 diabetes
Metformin is the most commonly used first-line drug for treating Type 2 diabetes1 After metformin, there are a number of treatment options available1 Combination therapy is reasonable, aiming to minimise side effects where possible Recent guidelines position GLP-1 receptor agonists as add-on to metformin or multiple OADs in the treatment pathway1 Ultimately, many patients will require insulin therapy1 Considerations when prescribing commonly-used non-insulin antidiabetic agents2 MET DPP4-i GLP-1 RA SGLT2-i SU TZD Hypoglycaemia risk Neutral Moderate / severe Weight Slight loss Loss Gain Renal impairment Contra-indicated Stage 3B–5 Dose adjustment required† Exenatide contraindicated CrCl <30 Infections More hypo risk May worsen fluid retention GI Sx Moderate Main talking point: As Type 2 diabetes progresses, patients typically follow a treatment pathway where additional agents are combined with the initial monotherapy (usually metformin) until insulin is required to help control hyperglycaemia. References Inzucchi SE, et al. Diabetes Care 2012;35:1364–79. Table adapted from Garber AJ, et al *In patients intolerant to metformin or for whom metformin is contraindicated. †Except linagliptin. CrCl, creatinine clearance; DPP4-i, dipeptidyl peptidase-4 inhibitor; GI, gastrointestinal; GLP-1, glucagon-like peptide-1; MET, metformin; OAD, oral antidiabetic drug; SGLT2-i, sodium-glucose co-transporter 2 inhibitor; SU, sulphonylurea; Sx, side effects; TZD, thiazolidinedione. Adapted from Inzucchi SE, et al. Diabetes Care 2012;35:1364–79; 2. Garber AJ, et al. Endocr Pract 2013;19:327–36.

32 Complexity of insulin regimens increases as Type 2 diabetes progresses
Non-insulin regimens Basal insulin only (usually with oral agents) Pre-mixed insulin twice daily Basal insulin +1 (mealtime) rapid-acting insulin injection + ≥2 (mealtime) rapid-acting insulin injections Regimen complexity Low High Number of injections 1 2 3+ Flexibility More flexible Less flexible Treatment convenience More convenient Less Main talking point: As Type 2 diabetes progresses, a patient on insulin therapy is likely to require increasingly complex insulin dosing strategies to maintain glycaemic control. Notes: Insulin therapy usually starts with basal insulin, in conjunction with one or two non-insulin agents. In certain patients, such as those with HbA1c ≥9.0% (74.9 mmol/mol) or willing to self-administer multiple injections, twice-daily pre-mixed insulin formulations or more advanced basal + mealtime insulin regimens could also be considered If additional control is required beyond the initial basal insulin regimen, basal + mealtime insulin may be considered, or the less common progression to a twice-daily premixed insulin Insulin dose titration is required after a regimen is initiated, and patient education around self-monitoring of blood glucose, diet, exercise and hypoglycaemia is critical Reference Inzucchi SE, et al. Diabetes Care 2012;35:1364–79. Adapted from Inzucchi SE, et al. Diabetes Care 2012;35:1364–79. Adapted from: Inzucchi SE, et al. Diabetes Care 2012;35:1364–79.

33 Use of GLP-1 receptor agonists early in the treatment pathway
Expert sound bite Placeholder for video 1Aviii. Paul Dromgoole: Use of GLP-1 receptor agonists early in the treatment pathway

34 Comparison of GLP-1 receptor agonists with insulin
GLP-1 receptor agonists offer a different suite of advantages and disadvantages for consideration when individualising care GLP-1 receptor agonist Insulin Hypoglycaemia risk Low High Weight change Loss Gain Major side effect(s) Gastrointestinal Hypoglycaemia Daily titration required? Additional blood glucose monitoring required? Costs Variable Main talking point: GLP-1 receptor agonists are injectable agents that offer a different range of advantages and disadvantages to insulin. GLP-1, glucagon-like peptide-1. Reference Inzucchi SE, et al. Diabetes Care 2012;35:1364–79. GLP-1, glucagon-like peptide-1. Adapted from Inzucchi SE, et al. Diabetes Care 2012;35:1364–79.

35 Advantages of new antidiabetic treatments
Expert sound bite Placeholder for video 1Aix. Paul Dromgoole: Advantages of new antidiabetic treatments

36 The 4-T study: Increasing the basal insulin dose does not always result in further HbA1c reductions
Mean changes in HbA1c Years since randomisation HbA1c (%) 9 8 7 6 0.5 1 1.5 2 2.5 3 Basal insulin Biphasic insulin Prandial insulin HbA1c (mmol/mol) 45 50 55 60 65 70 75 Mean changes in basal insulin dose Years since randomisation Daily insulin dose (IU/kg) 1.5 1.0 0.5 0.0 1 2 2.5 3 Basal insulin Biphasic insulin Prandial insulin Main talking point: For patients initiating basal insulin treatment, increasing the basal insulin dose does not always result in further reductions in HbA1c. Notes: The 4-T study was a 3-year, open-label, randomised study (N=708) of adult patients with Type 2 diabetes suboptimally controlled (HbA1c 7–10% [53.0–85.8 mmol/mol]) on metformin and a SU. Patients from 58 clinical centres in the UK and Ireland were enrolled in the study Patients were randomised to initiate biphasic insulin aspart twice daily, prandial insulin aspart three times daily, or basal insulin detemir once daily (twice, if required). The primary 3-year outcome HbA1C level The median HbA1c levels converged after 1 year and remained stable in all groups. The overall value at 3 years was 6.9% (51.9 mmol/mol) (95% CI, 6.8 to 7.1; p=0.28 between groups) At 3 years, the mean reduction from baseline was 1.3% (14.2 mmol/mol) in the biphasic insulin group, 1.4% (15.3 mmol/mol) in the prandial insulin group and 1.2% (13.1 mmol/mol) in the basal insulin group 4-T, Treating to Target in Type 2 diabetes; SU, sulphonylurea. Reference Holman R, et al. N Engl J Med 2009;361:1736–47. 4-T, Treating to Target in Type 2 diabetes. Adapted from Holman R, et al. N Engl J Med 2009;361:1736–47.

37 Basal insulin is sometimes not sufficient to achieve glycaemic control, even when titrated properly
Percentage of patients at target HbA1c(%) Percentage of patients who did not reach HbA1c ≤7.0% (≤53 mmol/mol) after 6 months of basal insulin therapy with forced titration to target FPG ≤5.5 mmol/L (100 mg/dL)1 Percentage of patients who did not reach HbA1c ≤7% (≤53 mmol/mol) after 6 months1 Percentage of patients at or below target HbA1c after 1 year of basal insulin therapy2 Percentage of patients achieving HbA1c ≤7% (≤53 mmol/mol) at 1 year2 Main talking point: Many patients receiving basal insulin do not reach the HbA1c goal of ≤7% (53 mmol/mol). Notes: A treat-to-target trial revealed that even when insulin is titrated to target FPG of ≤5.5 mmol/L (100 mg/dL), many patients taking insulin did not reach target HbA1c goals of ≤7.0% (≤53 mmol/mol) after 6 months1 An open-label, randomised study of adult patients with Type 2 diabetes who initiated basal insulin therapy demonstrated that a minority of patients achieved target HbA1c levels at 1 year: 27.8% of patients had HbA1c measurements ≤7.0% (≤53 mmol/mol)2 FPG, fasting plasma glucose. References Riddle MC, et al. Diabetes Care. 2003;26:3080–86. Holman R, et al. N Engl J Med. 2007;357:1716–30. FPG, fasting plasma glucose; NPH, neutral protamine Hagedorn. 1. Riddle MC, et al. Diabetes Care 2003;26:3080–6; 2. Holman R, et al. N Engl J Med 2007;357:1716–30.

38 Discussing potential use of injectable agents with patients for treatment of Type 2 diabetes
Expert sound bite Placeholder for video 1Ax. Paul Dromgoole: Discussing potential use of injectable agents with patients for treatment of Type 2 diabetes

39 Reasons why patients may be unwilling to begin insulin therapy
Significantly different? Low self-efficacy 58.1 39.7 Restrictiveness 56.1 41.6 Personal failure 55.0 33.6 Permanence 53.1 42.6 Anticipated pain 50.8 30.2 Problematic hypoglycaemia 49.3 37.9 Severity of illness 46.7 35.4 Lack of fairness 41.5 21.9 Expected harm 16.7 8.0 Main talking point: Patients’ willingness to starting insulin therapy can also be a barrier to treatment. Psychological insulin resistance is common: 28.2% of insulin-naïve patients with Type 2 diabetes reported that they would be unwilling to begin insulin if they had been prescribed it; a substantial proportion of remaining individuals reported significant reluctance. Notes: This study examined psychological insulin resistance in a study of 708 insulin-naïve patients with Type 2 diabetes (mean age, 57.4 years; average diabetes duration, 6.9 years) Participants were asked to complete a survey that examined their willingness to take insulin if it was prescribed, and to identify perceived attitudinal barriers to insulin therapy. Survey statements consisted of: Low self-efficacy: I’m not confident I could handle the demands of insulin therapy Restrictiveness: Insulin therapy would restrict my life; it would be harder to travel, eat out, etc. Personal failure: Insulin therapy would mean I had failed, that I hadn’t done a good enough job taking care of my diabetes Permanence: Once you start insulin, you can never quit Anticipated pain: I couldn’t take the needle every day; it would be just too painful Problematic hypoglycaemia: Insulin therapy might cause serious problems with low blood glucose Severity of illness: Taking insulin means my diabetes will become a more serious disease Lack of fairness: I’ve done everything I was supposed to; if I had to do insulin therapy, it just wouldn’t be fair Expected harm: Insulin therapy can cause problems, such as blindness Unwillingness to begin insulin therapy is usually multi-factorial, with the strongest reasons being beliefs about the permanence of insulin therapy (45%), restrictiveness of such a regime (45.2%), hypoglycaemia (43.3%) and a belief that it would indicate a sense of personal failure to manage their diabetes (43.3%) Reference Polonsky WH, et al. Diabetes Care 2005;28:2543–5. Data from n=3833 attendees at nine public sessions on ‘Taking control of your diabetes’ questionnaires were returned; 708 individuals had Type 2 diabetes and were not receiving insulin. *Percentages of patients responding that they would be slightly willing, 24.8%; moderately willing, 23.3%; very willing, 24.4%. Polonsky WH, et al. Diabetes Care :2543–5.

40 Patient beliefs and ability to engage with treatment
Expert sound bite Placeholder for video 1Axi. Paul Dromgoole: Patient beliefs and ability to engage with treatment

41 Changing patient and healthcare professional perceptions of injectable agents
Expert sound bite Placeholder for video 1Axii. Paul Dromgoole: Changing patient and healthcare professional perceptions of injectable agents

42 Halting Type 2 diabetes disease progression by physiological mechanisms
Expert sound bite Placeholder for video 1Axiii. Professor Stephan Jacob: Halting Type 2 diabetes disease progression by physiological mechanisms

43 Summary: Type 2 diabetes and individualised care
There are a number of unmet needs in Type 2 diabetes, which are in part fuelled by barriers to treatment such as: Weight gain Hypoglycaemia and patient fear of hypoglycaemia The progressive nature of the disease and patients’ unwillingness to start insulin Poor adherence to medication An individualised approach to diabetes care may help to overcome some barriers to treatment Main talking point: There is a great unmet need in Type 2 diabetes, with several key barriers to effective treatment. An individualised approach to diabetes management may help to overcome these barriers. Reference: Inzucchi SE, et al. Diabetes Care 2012;35:1364–79. Inzucchi SE, et al. Diabetes Care 2012;35:1364–79.


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