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Diabetes Management John B. Buse, MD, PhD Professor of Medicine

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Presentation on theme: "Diabetes Management John B. Buse, MD, PhD Professor of Medicine"— Presentation transcript:

1 Diabetes Management John B. Buse, MD, PhD Professor of Medicine
Chief, Division of Endocrinology Director, Diabetes Care Center University of North Carolina Chapel Hill, NC

2 CVD and Glycemia

3 Glycemic Goals of Therapy
Premeal plasma glucose (mg/dl) 2-h postprandial plasma glucose HbA1c ADA 70-130 (<180)* <7%† ACE <110 <140 <6.5% *If A1C remains above the desired target, postprandial levels, usually measured 90–120 min after a meal, may be checked. They should be <180 mg/dl to achieve A1C levels in the target range. †An A1C of ≥7% should serve as a call to action to initiate or change therapy with the goal of achieving an A1C level as close to the nondiabetic range as possible or, at a minimum, decreasing the A1C to 7%. Diabetes Care 30: S4-41, 2007 (http://care.diabetesjournals.org/cgi/reprint/30/suppl_1/S4)

4 Recent Glycemia CVD Studies
Characteristic ACCORD ADVANCE VADT N 10,251 11,140 1,791 Mean age 62 66 60 Hx CVD 35% 32% 40% BMI 32.2 28 31.3 BL mean A1C 8.3% 7.5% 9.4% BL meds 34% Ins/1.4 OAD 1% Ins/1.5 OAD 51% Ins/?? Statin use 62% % 28% % 58% % Antiplatelet use 54.5% % 48% % 76% % Study duration 3.4 5.0 6.0 Target A1C <6% vs 7-8% <6.5% vs “Usual” <6% vs 8-9% Achieved mean A1C 6.5% and 7.5% 6.3% and 7.0% 6.9% and 8.4% LDL at end 91 102 75 BP at end 127 / 67 136 / 74 127 / 69 Smokers at end 9.9% 8% 17% Skyler J, et al. Diabetes Care. 2009; 32:

5 Summary: Glucose Lowering on CVD in Type 2 Diabetes
VADT ACCORD ADVANCE Primary outcome Non-fatal MI Non-fatal stroke CVD death Hospitalization for CHF Revascularization Hazard Ratio for primary outcome (95% CI) 0.87 (0.73 – 1.04) 0.90 (0.78 – 1.04) 0.94 (0.84 – 1.06) Hazard Ratio for mortality (95% CI) 1.07 (0.80 – 1.42) 1.22 (1.01 – 1.46)* 0.93 (0.83 – 1.06) *P=0.04

6 ACCORD Treatment Effect on Primary Outcome
25 Standard therapy 20 HR=0.90 ( ), P=0.16 2.29%/yr Patients with events % 15 2.11%/yr 10 Intensive therapy 5 1 2 3 4 5 6 Time (yrs) ACCORD Study Group N Engl J Med 358: ; 2008

7 ACCORD: Hazard Ratios for Primary Outcome by Subgroup
Protocol Defined N Events Interaction P-value Subgroups Overall Primary Prevention Secondary Prevention Women Men Baseline Age< Baseline Age≥ Baseline A1C≤ Baseline A1C> Non-White White 0.6 1.0 1.4 ACCORD Study Group N Engl J Med 358: ;2008. HR (Intensive vs. Standard)

8 A1C During DCCT and Follow-Up
Intensive Conventional Conventional group encouraged to switch to intensive treatment 11 10 9 A1C (%) 8 During DCCT, intensive insulin therapy in people with type 1 diabetes significantly reduced HbA1C relative to those receiving conventional treatment. The intensively-treated group achieved a mean HbA1C of 7.1%, while the conventionally-treated patients had HbA1C of approximately 9.0%. During the EDIC (Epidemiology of Diabetes Intervention and Complications research group) follow-up of the DCCT cohort, all patients were encouraged to adopt intensive insulin therapy. During this time, HbA1C stablised to a similar level (just over 8%) in both treatment groups. 7 6 1 2 3 4 5 6 7 8 9 DCCT end 1 2 3 4 5 6 7 DCCT Year EDIC Adapted from: N Engl J Med 329:977–86,1993; EDIC: JAMA 287: 2563–9;2002 8

9 Cumulative Incidence of the First of Any Predefined CVD Outcomes
nonfatal MI, stoke, death from cardiovascular disease, confirmed angina, or the need for coronary-artery revascularization 0.12 Conventional treatment 0.10 Risk reduction 42%, CI - 9,63 Log-rank p = 0.016 0.08 Cumulative incidence of any CVD outcome 0.06 0.04 Intensive treatment 0.02 0.00 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 Years since entry Fatal MI, CVA, or CVD death ↓57% DCCT/EDIC Study Research Group, N Engl J Med 2005; 353: 9

10 UKPDS: “Legacy Effect” of Insulin/Sulfonylurea Therapy
After median 8.8 years post-trial follow-up Aggregate Endpoint Any diabetes related endpoint RRR: 12% 9% P: Microvascular disease RRR: 25% 24% P: Myocardial infarction RRR: 16% 15% P: All-cause mortality RRR: 6% 13% P: RRR = Relative Risk Reduction P = Log Rank Holman RR, et al. New England Journal of Medicine 2008; 359: 10

11 The “Natural History” of Type 2 Diabetes
Build up “bad” metabolic memory Drive the risk for complications A1C (%) TIME (yrs since diagnosis)

12 ADA – AHA – ACC Revised Glycemic Control Recommendations
Lowering A1C to below or around 7% has been shown to reduce microvascular and neuropathic complications of type 1 and type 2 diabetes. Therefore, for microvascular disease prevention, the A1C goal for non-pregnant adults in general is <7%. (A) ADA/AHA/ACC. Diabetes Care. 2009; 32:

13 ADA – AHA – ACC Revised Glycemic Control Recommendations
In type 1 and type 2 diabetes, randomized controlled trials of intensive vs. standard glycemic control have not shown a significant reduction in CVD outcomes during the randomized portion of the trials. Long-term follow-up of the DCCT and UKPDS cohorts suggests that treatment to A1C targets below or around 7% in the years soon after the diagnosis of diabetes is associated with long-term reduction in risk of macrovascular disease. Until more evidence becomes available, the general goal of <7% appears reasonable for many adults for macrovascular risk reduction. (B) ADA/AHA/ACC. Diabetes Care. 2009; 32:

14 ADA – AHA – ACC Revised Glycemic Control Recommendations
Subgroup analyses of clinical trials such as the DCCT and UKPDS, and the microvascular evidence from the ADVANCE trial, suggest a small but incremental benefit in microvascular outcomes with A1C values closer to normal. Therefore, for selected individual patients, providers might reasonably suggest even lower A1C goals than the general goal of <7%, if this can be achieved without significant hypoglycemia or other adverse effects of treatment. Such patients might include those with short duration of diabetes, long life expectancy, and no significant cardiovascular disease. (B) ADA/AHA/ACC. Diabetes Care. 2009; 32:

15 ADA – AHA – ACC Revised Glycemic Control Recommendations
Conversely, less stringent A1C goals than the general goal of <7% may be appropriate for patients with a history of severe hypoglycemia, limited life expectancy, advanced microvascular or macrovascular complications, extensive comorbid conditions, and those with longstanding 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 insulin. (C) ADA/AHA/ACC. Diabetes Care. 2009; 32:

16 Risk of Death over a Range of Average A1c
Adjusted log(Hazard Ratio) by Treatment Strategy Relative to Standard at A1c of 6% Steady increase of risk from 6 to 9% A1c with intensive strategy Intensive strategy Standard strategy 6 7 8 9 Excess risk with intensive strategy vs standard occurred above A1c 7% Average A1c %

17 Rates of Death During 3.4 Years of Treatment over a Range of 1-year Change of A1c
Adjusted Mortality Rates by Treatment Strategy Intensive strategy Excess risk with intensive strategy vs standard occurred when intensive participants failed to reduce A1c in year 1 Death rates per year Standard strategy 0.0 0.5 1.0 1.5 2.0 A1c decline from baseline over 12 months (%)

18 The Algorithm Screen, Diagnose, Treat

19 Screening Triggers for Prediabetes and Type 2 Diabetes
Preferred screening test is a venous FPG Screen all individuals aged ≥ 45 years; if normal, repeat at 3-year intervals Consider earlier and more frequent screening in individuals who are overweight (BMI ≥ 25 kg/m2) with additional risk factors: Habitual physical inactivity First-degree relative with diabetes Members of a high-risk ethnic population (eg, African American, Latino, Native American, Asian American, Pacific Islander) History of delivering a baby weighing > 9 lbs and/or GDM Hypertension (≥ 140/90 mm Hg) HDL-C < 35 mg/dL and/or triglyceride level > 250 mg/dL Polycystic ovarian syndrome History of IGT or IFG Other conditions associated with insulin resistance (eg, acanthosis nigricans) History of vascular disease Slide 9 – Page 6 (PRACTICE PEARL) The ADA recommendations for diabetes and prediabetes screening are listed here; however, new ADA guidelines will be issued soon. Many people in general medical care have 1 or more of these risk factors listed under the third bullet point. FPG screening every 3 years in most patients in primary care practices is probably reasonable. Note: There is currently no FDA-approved pharmacological treatment for prediabetes, but as you will see on the next slide, there are situations in which the ADA recommends using metformin in prediabetes. American Diabetes Association. Diabetes Care. 2008;31(suppl 1):S12-S54.

20 ADA and WHO Glucose Tolerance Categories
Fasting Plasma Glucose 2-hr Plasma Glucose on OGTT 5-10%/yr 10-15%/yr Diabetes Mellitus Diabetes Mellitus 126 mg/dL 200 mg/dL Impaired Fasting Glucose (IFG) Impaired Glucose Tolerance (IGT) “Pre- Diabetes” 100 mg/dL 140 mg/dL Normal Normal * Diagnosis of DM can also be made based on unequivocal symptoms and a random glucose >200 mg/dL. Any abnormality should be repeated and confirmed on a separate day.

21 Glucose is NOT a Standardized Analyte
CAP survey for glucose “ mg/dL”, mean 144 mg/dl* In order for an institution to be considered “proficient”, results should deviate by no more than 12 mg/dL or 20% from the peer group Inter-laboratory CV is 15.1% Variability in part due to differences between instruments CVs for individual instruments range from % Bottom line, depending on the type of device used, the mean glucose measurement for a particular sample reported by CAP certifiable institutions varies across an approximately 30% range In comparison, this is ~5% for many other analytes *Dungan K, et al. Diabetes Care 30: , 2007.

22 NGSP Standardization of the HbA1c Assay
CAP = College of American Pathologists ©2007 David M. Nathan

23 Consensus Statement IFCC, EASD, IDF, ADA
HbA1c assay to be standardized worldwide using the new IFCC standard and expressed as: % as currently used (DCCT values) IFCC units in mmol/mol eAG (estimated average glucose) in mg/dL All clinical guidelines should be expressed in these units Diabetes Care 30: , 2007

24 ADA Expert Committee on Diagnosis, 1997
Relation of FPG, 2hPG, HbA1c to Retinopathy: Egypt ADA Expert Committee, 1997

25 HbA1c Advantages Compared with FPG, OGTT
The HbA1c assay is standardized and aligned to DCCT/UKPDS Better index of overall glycemic exposure Equivalent in predicting risk for long-term complications Predicts CVD Substantially less laboratory variability Substantially less pre-analytic instability No need for fasting or timed samples Unaffected by acute (e.g. stress or illness-related) perturbations in glucose levels Used to guide management and adjust therapy

26 HbA1c: Limitations Laboratory Expense Not universally available
Patient-related: determinants in addition to glycemia Hemoglobinopathies Variation in red cell lifespan (hemolysis, blood loss, etc.) Unexplained racial differences Not useful as acute measure Selecting a diagnostic cut point On what basis? Will not always agree with diagnoses by FPG or OGTT Break with the past

27 Numbers of people with HbA1c ≥ 6
Numbers of people with HbA1c ≥ 6.5%, FPG ≥ 126 mg/dl, or 2hPG ≥ 200 mg/dl adult Pima Indians without previous dx. 2-hr PG (n=237) 10% HbA1c (n=182) 7% 18 73 37 125 21 2 None = 2142 Any = (12%) Total = 2435 17 FPG (n=165) 7%

28 Prevention of Type 2 Diabetes
Study Subjects Intervention Relative Risk Reduction DaQing Finnish DPS US DPP IGT IGT + “IFG” Diet or Exercise or Both Lifestyle 64%/53%/61% STOP-NIDDM EDIT TRIPOD XENDOS DREAM ACT-NOW ORIGIN NAVIGATOR IFG Prior GDM IFG or IGT IGT+IFG Metformin Acarbose Metformin or Acarbose or Both Troglitazone Orlistat Rosiglitazone or Ramipril or Both Pioglitazone Glargine or Fish oil or Both Nateglinide or Valsartan or Both 31% 25% NS 35% 45% 61%/NS 81% ~2010 ~2009 Behavior Medication During year 3 or 4 of the EDIC study, microalbuminuria was detected for the first time in 11% of 573 patients in the former conventional therapy groups, as compared with 5% in the intensive-therapy group, representing a 53% odds reduction. Li et al., Lancet 2008;371: ADA Position Statement on the Prevention or Delay of Type 2 Diabetes. Diabetes Care. 2002;25: Torgerson JS, et al. Diabetes Care. 2004;27: DREAM Trial Investigators. Lancet. 2006;368: DREAM Trial Investigators. N Engl J Med. 2006;355: DeFronzo RA, et al. ADA 68th Scientific Sessions Origin Trial Investigators. Am Heart J 2008;155:26-32.

29 Prevention Of Type 2 Diabetes: Completed Lifestyle Trials In IGT Key Points
Lifestyle therapy can be very effective in preventing or delaying diabetes The lifestyle therapy that works involves three core features Balanced low-calorie nutrition: low fat, high in fiber (vegetables, fruits, whole grains) Regular physical activity: aerobic and resistance, 30+ minutes most days of the week Frequent intervention with dietitians and lifestyle coaches: ~weekly for first month ~monthly for the first three months ~every three months for life

30 Prevention of Type 2 Diabetes
Study Subjects Intervention Relative Risk Reduction DaQing Finnish DPS US DPP IGT IGT + “IFG” Diet or Exercise or Both Lifestyle 64%/53%/61% STOP-NIDDM EDIT TRIPOD XENDOS DREAM ACT-NOW ORIGIN NAVIGATOR IFG Prior GDM IFG or IGT IGT+IFG Metformin Acarbose Metformin or Acarbose or Both Troglitazone Orlistat Rosiglitazone or Ramipril or Both Pioglitazone Glargine or Fish oil or Both Nateglinide or Valsartan or Both 31% 25% NS 35% 45% 61%/NS 81% ~2010 ~2009 Behavior Medication NOT FDA APPROVED FOR PREVENTION NOT FDA APPROVED FOR PREVENTION During year 3 or 4 of the EDIC study, microalbuminuria was detected for the first time in 11% of 573 patients in the former conventional therapy groups, as compared with 5% in the intensive-therapy group, representing a 53% odds reduction. Li et al., Lancet 2008;371: ADA Position Statement on the Prevention or Delay of Type 2 Diabetes. Diabetes Care. 2002;25: Torgerson JS, et al. Diabetes Care. 2004;27: DREAM Trial Investigators. Lancet. 2006;368: DREAM Trial Investigators. N Engl J Med. 2006;355: DeFronzo RA, et al. ADA 68th Scientific Sessions Origin Trial Investigators. Am Heart J 2008;155:26-32.

31 Screening and Diagnosis: Intervention and Follow-Up
Screen for Diabetes: FPG or 2-hour, 75-g OGTT Normal Re-evaluate in ≤3 years if risk factors remain IFG: fasting (8 hours) plasma glucose mg/dL IGT: 2-hour value in 75-g OGTT mg/dL Lifestyle intervention; 1 year IFG or IGT † Follow-up here refers to formal reassesment of glycemic status. Follow-up should be individualized with respect to venue, frequency and goals. IFG and IGT + Other Features* Lifestyle intervention and/or metformin; 6 mo. * “Other features”: < 60 years of age and BMI ≥ 30 kg/m2 and either A1C > 6.0%, hypertension, low HDL, high triglycerides or family history of diabetes in first-degree relative Diabetes Lifestyle intervention plus metformin; 3 mo. Diabetes: fasting ≥126 mg/dl or 2-hour ≥200 mg/dl; should be confirmed on a separate day unless unequivocally elevated and/or symptomatic Slide 10 – Page 7 Slide 10 is adapted from ADA position statements on: 1) management of type 2 diabetes and 2) management of impaired fasting glucose (IFG) or IGT. The key points include: Everybody older than 45 should be screened for diabetes. People younger than 45 who are overweight and have a risk factor should be screened as well. Overweight children with 2 risk factors for diabetes should be screened even in childhood at the time of puberty. Screen at least every 3 years, or more frequently in patients with risk factors or elevated glucose. The screening test is FPG (where the fasting interval is 8 hours) or the 2-hour, 75-g oral glucose tolerance test (OGTT). In children, the dose is 1.75 g/kg up to a maximum of 75 g. The criteria for abnormalities of glucose tolerance are listed toward the bottom of the slide. To use metformin, you should do OGTT. If you do the OGTT you’ll find that a fair number of people with IFG are actively diabetic, and metformin would be effective in this situation. Note to speaker: please turn the meeting over to the moderator BREAK: 5 minutes (:10 / :40 to :15 / :45) Moderator will first present the answers to the first polling question, Janelle Speaker: - Please give your thoughts on the polling The moderator will ask the group for questions. If there are no questions, the moderator can ask the speaker / audience: Since the prevalence of type 2 diabetes is increasing, and obesity is so widespread in this country, should we just be doing mass screenings for diabetes? What proportion of patients do you screen for type 2 diabetes in your own practice? Note to Speaker: Moderator will turn the call back over to you to present the next section, starting with slide 11 once the question-and answer session is complete. American Diabetes Association. Diabetes Care. 2009;32(suppl 1):S13-S61. METFORMIN IS NOT FDA APPROVED FOR PREVENTION

32 Updated ADA/EASD Consensus Algorithm
At Diagnosis: Lifestyle + Metformin Lifestyle + Metformin Sulfonylureaa Basal Insulin Intensive Insulin Pioglitazone GLP-1 agonistb STEP 1 STEP 2 STEP 3 Tier 2: Less well-validated therapies Tier 1: Well-validated therapies Reinforce lifestyle interventions at every visit and check A1C every three months until A1C < 7.0 %, then at least every 6 months thereafter. Change interventions whenever A1C ≥ 7.0 %. aSulfonylureas other than glybenclamide (glyburide) or chlorpropamide. bInsufficient clinical use to be confident regarding safety. Nathan DM, et al., Diabetes Care 2008;31:1-11.

33 Hazard Ratio for Cardiovascular Events Rosiglitazone vs Pioglitazone
1.43 Nissen meta-analysis: MI 1.64 Nissen meta-analysis: CV death 1.31 GSK analysis: CV death, MI, stroke Psaty/Furberg (RECORD, ADOPT, DREAM, all small trials): MI 1.33 1.16 RECORD: MI FDA: CV death, MI, stroke 1.2 FDA-PIO meta-analysis 0.75 1.4 FDA: all ischemic events, no CI given 0.90 PROactive 1° PROactive 2° 0.84 0.83 FDA-PIO meta-analysis + PROactive Hazard Ratio 0.75 1.25 1.5 1.75 1.0 Adapted from: Lincoff AM, et al. JAMA. 2007;298: ; Singh S, et al. JAMA. 2007;298:

34 Fractures in Women Treated With Glitazones
Kahn SE, et al. Diabetes Care. 2008;31:

35 13 Classes of Antihyperglycemic Agents Available for Treatment of Type 2 Diabetes
A1C Reduction Fasting vs PPG Hypo- glycemia Weight Change Dosing (times/day) Outcome Studies Metformin 1.5 No Neutral 2 UKPDS Insulin, long acting Yes Gain 1, Injected DIGAMI, UKPDS, (DCCT) Insulin, rapid acting PPG 1-4, Injected Sulfonylureas 1 Thiazolidinediones PROactive, RECORD GLP-1 agonists Loss 2, Injected None Repaglinide Both 3 Nateglinide Rare NAVIGATOR Pending α-Glucosidase inhibitor ACE pending Amylin mimetics 3, Injected DPP-4 inhibitors TECOS pending Bile acid sequestrant 0.5 1-2 Bromocriptine 0.7 Adapted from: Nathan DM, et al. Diabetes Care. 2007;30: Nathan DM, et al. Diabetes Care. 2006;29: Nathan DM, et al. Diabetes Care. 2009;32: ADA. Diabetes Care. 2008;31:S12-S54. WelChol PI. 1/ Cycloset PI. 5/2009.

36 Brunzell JD, et al. Diabetes Care 31:811-822, 2008
Suggested Treatment Goals in Patients with CMR and Lipoprotein Abnormalities Goals LDL cholesterol Non-HDL cholesterol ApoB (mg/dl) Highest-risk patients, including those with 1) known CVD or 2) diabetes plus one or more additional major CVD risk factor <70 <100 <80 High-risk patients, including those with 1) no diabetes or known clinical CVD but two or more additional major CVD risk factors or 2) diabetes but no other major CVD risk factors <130 <90 Other major risk factors (beyond dyslipoproteinemia) include smoking, hypertension, and family history of premature CAD. Brunzell JD, et al. Diabetes Care 31: , 2008

37 Effectiveness of Aspirin in Diabetes
RR .81 p < 0.002 25 22% 20 Patients Experiencing Cardiovascular Events (%) RR .83 p = 0.004 18% RR .39 p = ns 15 12% 10 10% 9% 5 4% Placebo ASA Placebo ASA Placebo ASA US MDs* APT† ETDRS‡ * Physician’s Health Study, NEJM 1989 † Antiplatelet Trialists’ Collaboration, BMJ 1994 ‡ Early Treatment Diabetes Retinopathy Study, JAMA 1992

38 Improvement In Key Clinical Measures
% of Adult Patients with * Lower is better for this measure. 38

39 STENO -2 Multi-Risk Factor Intervention in Type 2 DM
Intensive group end results: A1C 7.7%, BP 140/74, LDL 71 mg/dL, HDL 51 mg/dl, TG 99 mg/dL, aspirin 85% Gaede P. N Engl J Med 2008; 358:

40 Room for Improvement in Therapy Implementation and Change
Rates of Medical Regimen Change in 30 US Academic Medical Centers 100 N=1765 Patients With Diabetes 90 <50% of Patients With A1C Above Goal had Their Medication Changed 80 70 % of Patients 60 Even Lower Percentage of Patients Whose CV Goals Were not Met had Medication Started 50 40 30 OBJECTIVE: To assess both standard and novel diabetes quality measures in a national sample of U.S. academic medical centers. RESEARCH DESIGN AND METHODS: This retrospective cohort study was conducted from 10 January 2000 to 10 January It involved 30 U.S. academic medical centers, which contributed data from 44 clinics (27 primary care clinics and 17 diabetes/endocrinology clinics). For 1,765 eligible adult patients with type 1 or type 2 diabetes with at least two clinic visits in the 24 months before 10 January 2002, including one visit in the 6 months before 10 January 2002, we assessed measurement and control of HbA(1c), blood pressure, and cholesterol and corresponding medical regimen changes at the most recent clinic visit. RESULTS: In this ethnically and economically diverse cohort, annual testing rates were very high (97.4% for HbA(1c), 96.6% for blood pressure, and 87.6% for total cholesterol). Fewer patients were at HbA(1c) goal (34.0% <7.0%) or blood pressure goal (33.0% <130/80 mmHg) than lipid goals (65.1% total cholesterol <200 mg/dL, 46.1% with LDL cholesterol <100 mg/dL). Only 10.0% of the cohort met recommended goals for all three risk factors. At the most recent clinic visit, 40.4% of patients with HbA(1c) concentrations above goal underwent adjustment of their corresponding regimens. Among untreated patients, few with elevated blood pressure (10.1% with blood pressure >130/80 mmHg) or elevated LDL cholesterol (5.6% with LDL >100 mg/dL) were started on corresponding therapy. Patients with type 2 diabetes were no less likely to be intensified than patients with type 1 diabetes. CONCLUSIONS: High rates of risk factor testing do not necessarily translate to effective metabolic control. Low rates of medication adjustment among patients with levels above goal suggest a specific and novel target for quality improvement measurement. 20 10 >7 >8 >9 >130/80 >140/90 >150/100 >100 >130 >160 A1C (%) BP (mm Hg) LDL (mg/dL) *P<.05 for A1C and LDL (P values are derived from Mantel-Haenszel test for trend). Grant RW, et al. Diabetes Care. 2005;28: 40


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