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Type 2 Diabetes: Disease State Overview

Type 2 Diabetes: Disease State Overview. AF2086R0. Suggestions for Slide Deck Use. The following unbranded slides are provided as a disease state library and may be used as background information at the beginning of any promotional program

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Type 2 Diabetes: Disease State Overview

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  1. Type 2 Diabetes: Disease State Overview AF2086R0

  2. Suggestions for Slide Deck Use • The following unbranded slides are provided as a disease state library and may be used as background information at the beginning of any promotional program • These slides should always supplement the affirmative deck unless the program is scheduled to be "disease state only"

  3. Diabetes Disease State Overview • Diabetes: epidemiology/pathophysiology • Prevalence and burden of diabetes • Core defects of type 2 diabetes • Complications and costs associated with type 2 diabetes • Predicting and preventing type 2 diabetes • Treatment goals and strategies • Improving glycemic control • Reducing diabetes-related complications • Treating the whole patient

  4. Every Day in the United States Approximately… 66 people lose their eyesight because of diabetes 128 people begin treatment for end-stage renal disease (ESRD) More than 4000 new cases* of diabetes will be diagnosed today 195 lower-limb amputations are performed because of diabetes 640 people die from diabetes and its complications *Patients ages ≥20 years. Centers for Disease Control. National Diabetes Fact Sheet. http://www.cdc.gov/diabetes/pubs/pdf/ndfs_2007.pdf. Accessed March 5, 2009.

  5. ≈23.5 Million (10.7%) Americans 20 Years or Older Have Diabetes (Diagnosed or Undiagnosed)* 23.8 Percentage 10.8 2.6 20–39 40–59 60+ Age group *Data is from 2003–2006, projected to year 2007. NIDDK. National Diabetes Statistics. 2007. Available at: http://diabetes.niddk.nih.gov/dm/pubs/statistics/#y_people.Accessed February 11, 2009.

  6. Adults Diagnosed with Diabetes in the United States* 1.6 million new cases of diabetes were diagnosed in people aged 20 years or older in 2007 Total economic costs of diabetes estimated to be $174 billion (2007) 819,000 536,000 Number 281,000 20–39 40–59 60+ Age group *Data is from 2004–2006, projected to year 2007. NIDDK. National Diabetes Statistics. November 2007. Available at: http://diabetes.niddk.nih.gov/dm/pubs/statistics/#y_people.Accessed February 11, 2009.

  7. Age-adjusted Total Prevalence of Diabetes in the United States by Race/Ethnicity (Age ≥20) 17 American Indians/Alaska Natives 12 Non-Hispanic Blacks 10 Hispanic/Latino Americans 8 Asian Americans 7 Non-Hispanic Whites 0 2 4 6 8 10 12 14 16 18 20 Percentage NIDDK. National Diabetes Statistics. November 2007. Available at: http://diabetes.niddk.nih.gov/dm/pubs/statistics/#y_people.Accessed February 11, 2009.

  8. Economic Consequences of Diabetes Total Annual Cost in 2002: $132 Billion Indirect costs* = $40 billion Direct costs† = $92 billion Disability and early mortality Diabetes and diabetes supplies $23 billion $40 billion $25 billion Chronic complications $44 billion General medical conditions *Indirect costs include lost productivity, disability, and premature mortality. †Direct costs include: hospital inpatient care, nursing home care, physician office visits, total home healthcare costs, costs associated with hospice care, and diabetes supplies. Stolar MW et al. JMCP. 2008;14:S1–S19.

  9. 0 5 10 15 Annual Medical Expenditures and Length ofTime with Diabetes Annual cost increases with length of time with diabetes Diagnosis of diabetes at age 50 Diagnosis of diabetes at age 65 Cost in 2005 (dollars) Duration of Diabetes (Years) Adapted from Trogdon JG et al. Diabetes Care. 2008;31:2307–2311.

  10. Pathophysiology of Type 2 Diabetes • Type 2 diabetes results from a progressive insulin secretory defect on the background of insulin resistance1 • Key pathophysiologic mechanisms leading to hyperglycemia in type 2 diabetes • Insulin resistance2,3 • Beta-cell dysfunction3 1. American Diabetes Association. Diabetes Care. 2009;32:S13–S61. 2. DeFronzo RA. Med Clin North Am. 2004;88:787–835. 3. Kahn SE. J Clin Endocrinol Metab. 2001;86:4047–4058.

  11. Two Defects Contributing to Type 2 Diabetes Obesity (visceral)2 Obesity (visceral)1 Insulin resistance Beta-cell dysfunction Liver Muscle tissue Adipose tissue Pancreas Beta-cell Type 2 Diabetes 1. Buchanan TA. Clin Ther. 2003;25(suppl 2):B32–B46. 2. Kahn SE. J Clin Endocrinol Metab. 2001;86:4047–4058.

  12. Natural Progression of Insulin Resistance in Patients with Type 2 Diabetes1,2 Insulin resistance Insulin production & secretion/ Beta-cell function Fasting plasma glucose Normal glycemia Insulin resistance rises, leading to beta cells working overtime to secrete more insulin Beta cells are unable to produce the insulin needed to compensate for the increased level of insulin resistance, causing glucose levels to rise, leading to type 2 diabetes* *Type 2 diabetes is diagnosed when FPG is ≥126 mg/dL.3 Adapted from International Diabetes Center, Minneapolis, MN.1 1. Bergenstal RM et al. Endocrinology. 4th ed. Philadelphia, PA: WB Saunders Company;2001:821–835. 2. Ramlo-Halsted BA, Edelman SV. Clin Diab. 2000;18:80–85. 3. American Diabetes Association. Diabetes Care. 2008;31(suppl1):S12–S54.

  13. Type 2 Diabetes Associated with Serious Complications Stroke DiabeticRetinopathy CV Disease & Stroke account for ~65% of deaths in T2D patients Leading cause of blindness in adults CardiovascularDisease Diabetic Nephropathy DiabeticNeuropathy Major cause of kidney failure Major cause of lower extremity amputations CV = cardiovascular. National Institute of Diabetes and Digestive and Kidney Diseases. National Diabetes Statistics fact sheet: general information and national estimates on diabetes in the United States, 2005. Bethesda, MD: U.S. Department of Health and Human Services, National Institute of Health, 2005.

  14. Prevalence of Multiple Complications Among People with Type 2 Diabetes American Association of Clinical Endocrinologists. State of Diabetes Complications in America Report. Available at: http://www.aace.com/newsroom/press/2007/images/DiabetesComplicationsReport_FINAL.pdf. Accessed March 5, 2009.

  15. Prevalence of Macrovascular and Microvascular Complications of Diabetes ‡ † * Macrovascular Microvascular *In NHANES, “chronic kidney disease" refers to people with microalbuminuria (albumin:creatinine ratio >30 µg/mg). †In the NHANES analysis, "foot problems" includes foot/toe amputations, foot lesions, and numbness in the feet. ‡"Eye damage" includes a positive response by NHANES participants to the question, "Have you been told diabetes has affected your eyes/had retinopathy?" Retinopathy is damage to the eye's retina. In NHANES, people without diagnosed diabetes were not asked this question, therefore, prevalence information for nondiabetics is not available. CHD = coronary heart disease; CHF = congestive heart failure. American Association of Clinical Endocrinologists. State of Diabetes Complications in America Report. Available at: http://www.aace.com/newsroom/press/2007/images/DiabetesComplicationsReport_FINAL.pdf. Accessed March 9, 2009.

  16. Prevalence of Diabetic Retinopathy 40.3%* Prevalence of retinopathy in diabetics age ≥40 years (%) 8.2%† ‡ § *95% CI: 38.8%–41.7% †95% CI: 7.4%–9.1% ‡Diabetic retinopathy defined as a retinal vascular disorder characterized by signs of retinal ischemia and/or signs of increased retinal vascular permeability. Retinopathy severity level ≥14 retinopathy and/or macular edema. §Vision threatening retinopathy defined as severe retinopathy and/or diabetic macular edema. Retinopathy severity level ≥50 and/or macular edema. Kempen JH et al. Arch Ophthalmol. 2004;122:552–563.

  17. Number of Cases with ESRD Due to Diabetic Nephropathy Is Increasing in the United States Diabetes is the leading cause of ESRD 50 40 30 Number of cases (thousands) 20 10 0 1990 1991 1992 1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 Year ESRD = end-stage renal disease. CDC. Morbidity and Mortality Weekly Report. 2005;54(43)1097–1100.

  18. CV Risk in Patients with Diabetes and No Prior MI Is Similar to Risk in Nondiabetics with Prior MI A population study of 3.3 million people Men Women 5-year incidence (%) CV = cardiovascular. For CV death, the hazard ratio was 2.42 in men with diabetes only and 2.44 in men with a prior MI only (P=0.60). Results for women were 2.45 and 2.62, respectively (P<0.001). Schramm TK et al. Circulation. 2008; 117:1945–1954.

  19. Annual National Cost of Type 2 Diabetes and Related Complications* Cost in billions *Cost estimates in this report were adjusted for inflation to reflect 2006 costs. American Association of Clinical Endocrinologists. State of Diabetes Complications in America Report. Available at: http://www.aace.com/newsroom/press/2007/images/DiabetesComplicationsReport_FINAL.pdf. Accessed March 5, 2009.

  20. Individual Costs by Complication* $ 1785 Eye damage Total expenditures $ 480 Out-of-pocket costs $ 4687 Foot problems $ 153 $ 6062 CHD $ 224 $ 7806 Stroke $ 448 $ 7932 CHF $ 510 $ 9002 Chronic kidney disease $ 439 $ 14,150 Heart attack $ 574 $ $ $ $ $ $ $ $ $ 0 2000 4000 6000 8000 10,000 12,000 14,000 16,000 Annual Healthcare Costs *Cost estimates in this report were adjusted for inflation to reflect 2006 costs. American Association of Clinical Endocrinologists. State of Diabetes Complications in America Report. Available at: http://www.aace.com/newsroom/press/2007/images/DiabetesComplicationsReport_FINAL.pdf. Accessed March 5, 2009.

  21. Algorithm to Estimate Type 2 Diabetes Risk According to a study in a middle-aged white population, total points ≥25 corresponds to >35% 8-year risk of type 2 diabetes. Wilson PW et al. Arch Intern Med. 2007;167:1068–1074.

  22. Preventing Development of Type 2 Diabetes • Screening for prediabetes and asymptomatic type 2 diabetes should be considered in adults who are overweight or obese (BMI ≥25 kg/m2)and have additional risk factors • In those without risk factors, testing should begin at age 45 years • If results are normal, testing should be repeated at least every 3 years • Counseling on lifestyle modification is recommended for patients with impaired fasting glucose or impaired glucose tolerance • Weight-loss goal of 5%–10% of initial body weight • Physical activity with moderate intensity for 150 minutes per week American Diabetes Association. Diabetes Care. 2009;32(suppl 1):S13–S61.

  23. Summary of Diabetes: Epidemiology/Pathophysiology Diabetes and diabetes-related complications (eg, heart disease, kidney disease, blindness, amputations) are highly prevalent1 The pathophysiology of diabetes involves the development of insulin resistance and beta-cell dysfunction2 Diabetes is strongly correlated with a number of microvascular risk factors and diseases, and is a contributor to macrovascular disease and mortality1 Routine clinical measures may be used to identify patients at risk of developing type 2 diabetes who may benefit from lifestyle counseling3 1. NIDDK. National Diabetes Statistics. November 2007. Available at: http://diabetes.niddk.nih.gov/dm/pubs/statistics/#y_people.Accessed February 11, 2009. 2. Kahn SE. J Clin Endocrinol Metab. 2001;86:4047–4058. 3. American Diabetes Association. Diabetes Care. 2009;32(suppl 1):S13–S61.

  24. Diabetes Disease State Overview • Diabetes: epidemiology/pathophysiology • Prevalence and burden of diabetes • Core defects of type 2 diabetes • Complications and cost associated with type 2 diabetes • Predicting and preventing type 2 diabetes • Treatment goals and strategies • Improving glycemic control • Reducing diabetes-related complications • Treating the whole patient

  25. Criteria for the Diagnosis of Diabetes Mellitus: ADA Standards of Medical Care, 2009 FPG 126 mg/dL (7.0 mmol/L) Fasting is defined as no caloric intake for at least 8 hours OR Symptoms of hyperglycemia plus casual plasma glucose concentration 200 mg/dL (11.1 mmol/L) Casual is defined as any time of day without regard to time since last meal The classic symptoms of hyperglycemia include polyuria, polydipsia, and unexplained weight loss OR 2-h plasma glucose 200 mg/dL (11.1 mmol/L) during an OGTT The test should be performed as described by WHO, using a glucose load containing the equivalent of 75 g anhydrous glucose dissolved in water ADA = American Diabetes Association; OGTT = oral glucose tolerance test, WHO = World Health Organization. American Diabetes Association. Diabetes Care. 2009;32:S13–S61.

  26. Recommendations for Early Pharmacologic Treatment from AACE and ADA To reduce the risk of serious disease-related complications,1,2AACE recommends Target A1C goal of ≤6.5%2 Earlier intervention with appropriate therapies and persistent titration to achieve goal2 ADA recommends3 Target A1C goal of <7% “for most patients” Achieving and maintaining glycemic goals and changing interventions when therapeutic goals are not being met AACE = American Association of Clinical Endocrinologists. 1. Stratton IM et al. BMJ. 2000;321:405–412. 2. AACE Diabetes Mellitus Clinical Practice Guidelines Task Force. Endocr Pract. 2007;13(suppl 1):4–68. 3. American Diabetes Association. Diabetes Care. 2009;32:S13–S61.

  27. Conventional MonotherapiesUnable to Maintain Glycemic Control Over Time 10 Conventional* 9 Insulin Glibenclamide (glyburide) 8 MET ADA Goal 7 AACE Goal 6 0 0 3 6 9 12 15 United Kingdom Prospective Diabetes Study (UKPDS) Median A1C (%) Time from randomization (years) FPG = fasting plasma glucose; MET = metformin.*Conventional therapy defined as dietary advice given at 3-month intervals where FPG was targeted at best levels feasible in clinical practice. If FPG exceeded 270 mg/dL, patients were re-randomized to receive nonintensive MET, chlorpropamide, glibenclamide, or insulin. If FPG exceeded 270 mg/dL again, those on SU would have MET added. If FPG exceeded 270 mg/dL after this, insulin was substituted.Adapted from UK Prospective Diabetes Study (UKPDS 34) Group. Lancet. 1998;352:854–865.

  28. Glycemic Targets Are Not Being Achieved Worldwide EUROPE (RECAP-DM)3 CANADA (DICE)1 UNITED STATES (NHANES)2 HbA1c <6.5% HbA1c <7% HbA1c <7% 26% 51% 57%    49% 43% 74% Patients reaching glycemic target Patients not reaching glycemic target DICE = Diabetes in Canada Evaluation; NHANES = National Health and Nutrition Examination Surveys; RECAP-DM = Real-life Effectiveness and Care Patterns of Diabetes Management. 1. Harris SB et al. Diabetes Res Clin Pract. 2005;70:90–97. 2. Ong et al. Ann Epidemol. 2008;18:222–229. 3. Guisasola et al. Diabetes Obes Metab. 2008;10:8–15.

  29. Patients Remain on Monotherapy >2 Years After First A1C >8.0%* Length of time between first monotherapy (A1C >8.0%) and switch/addition in therapy* 35.1 SU Only 26.5 MET Only 0 6 12 18 24 30 36 Months *May include uptitration. Based on a prospective, population-based study using retrospective observational data. Brown JB et al. Diabetes Care. 2004;27:1535–1540.

  30. Risk of CV Events or Death Increased with HbA1c Level (EPIC-Norfolk) 5–5.4% HbA1c level: 5.5–5.9% 6.0–6.4% 6.5–6.9% 7% Men Women 7.96 8 7.07 6.91 7 6 5.01 5 4.73 Age-adjusted relative risk (95% CI) 4 3.49 3.44 3.38 3.03 3.06 3 2.37 2.13 2.29 2.00 1.79 1.80 2 1.63 1.70 1.56 1.57 1.56 1.61 1.23 1.25 1.28 1.04 0.98 1.02 0.96 1 0.89 0 CHD events CVD events All-cause mortality CHD events CVD events All-cause mortality P0.001 for linear trend across HbA1c categories for all endpoints. CHD = coronary heart disease; CI = confidence interval; CVD = cardiovascular disease; EPIC-Norfolk = European prospective investigation into cancer in Norfolk. • Khaw KT et al. Ann Intern Med 2004; 141:413–420.

  31. Multifactorial Approach: Strategies for Reducing Diabetic Complications—Treating the Whole Patient • Strategies for reducing microvascular complications • Routine screening for diabetes • Optimized glycemic control • Optimized BP control • Strategies for reducing macrovascular complications • Optimized glycemic control • Treatment of hypertension and other established cardiovascular risk factors in diabetic and possibly prediabetic subjects* • Lipid control* • Antiplatelet therapy* *For appropriate patient population based on treatment guidelines. American Diabetes Association. Diabetes Care. 2008;31(suppl 1):S12–S54.

  32. Improved Glycemic Control Has Been Shown to Help Reduce the Risk of Complications According to the United Kingdom Prospective DiabetesStudy (UKPDS) 35, every 1% decrease in A1C resulted in: 21% 37% Decrease in risk of microvascular complications (P<0.0001) Decrease in risk of any diabetes-related endpoint (P<0.0001) Stratton IM et al. BMJ. 2000;321:405–412.

  33. UKPDS: Long-Term Intensive Glucose Control in Type 2 Diabetes Multicenter, randomized study with 10-year follow-up1 One of the longest and largest type 2 diabetes trials ever conducted2 4209 patients newly diagnosed with type 2 diabetes1 Study Design After a 3-month run-in period, patients with FPG >108 mg/dL but <270 mg/dL were randomized to receive either intensive therapy (SU or insulin or, if more than 120% of ideal body weight, MET) or conventional therapy (diet only)1 Primary study objective To determine whether long-term improved glycemic control was able to sustain risk reductions in microvascular complications, and if intensive therapy had a long-term effect on macrovascular outcomes1 Primary outcome Prespecified aggregate clinical outcomes were any diabetes-related endpoint, diabetes-related death, death from any cause, myocardial infarction, stroke, peripheral vascular disease, and microvascular disease1 FPG = fasting plasma glucose. 1. Holman et al. N Engl J Med. 2008;359:1577–1589. 2. Lawton J et al. Br J Gen Pract. 2003;53:394–398.

  34. Sustained Intensive Glycemic Control Can Reduce Diabetes-Related Complications Risk Reductions for Intensive-Therapy Regimens at 10-Year Follow-up • Long-term intensive glycemic control is associated with a significantly decreased risk of MI or death from any cause, in addition to known risk reductions in microvascular disease SU- insulin SU- insulin SU- insulin SU- insulin MET MET MET MET -9% -13% -16% -15% -21% -24% -27% -33% Any diabetes-related endpoint (P = 0.04 for SU-insulin; P = 0.01 for MET) Microvascular disease (P = 0.001 for SU-insulin; P = 0.31 for MET) Myocardial infarction (P = 0.01 for SU-insulin; P = 0.005 for MET) Death from any cause (P = 0.007 for SU-insulin; P = 0.002 for MET) Holman et al. N Engl J Med. 2008;359:1577–1589.

  35. Treating the Whole Patient: Statin Therapy in Patients with Diabetes Reduced CV Risk (CARDS) 1410 1351 1306 1022 651 305 Placebo 1428 1392 1361 1074 694 328 Atorvastatin Relative CV Risk Reduction 37% (95% CI: –52 to –17) 15 P = 0.001 Placebo 127 CV events* 10 Atorvastatin 83 CV events* Cumulative hazard (%) 5 0 0 1 2 3 4 4.75 Years *CV events included stroke. CARDS = Collaborative Atorvastatin Diabetes Study. Colhoun HM et al. Lancet. 2004;364:685–696.

  36. Treating the Whole Patient: Patients Reaching Intensive Treatment Goals at 7.8 Years* (Steno-2) 80 P<0.001 P = 0.21 70 P = 0.19 60 50 P = 0.001 40 Patients (%) 30 20 P = 0.06 10 0 A1C <6.5% Diastolic BP <80 mmHg Cholesterol <175 mg/dL Triglycerides <150 mg/dL Systolic BP <130 mmHg Intensivetherapy (n = 80)† Conventionaltherapy (n = 80)‡ *Mean. †Intensive treatment included stepwise implementation of behavior modification and pharmacologic therapy that targeted hyperglycemia, hypertension, dyslipidemia, and microalbuminuria, along with secondary prevention of cardiovascular disease with aspirin. ‡Conventional treatment was based on the Danish Medical Association guidelines. Gæde et al. N Engl J Med. 2003;348:383–393.

  37. Treating the Whole Patient: Intensive Therapy Reduced Composite Macrovascular Endpoints (Steno-2) 60 Conventional therapy 50 HR† = 0.47 (95% CI, 0.24-0.73) 53% 40 Primary composite endpoint* (%) 30 20 Intensive therapy 10 0 72 0 12 24 36 48 60 84 96 Months of Follow-up *Composite endpoint of death from cardiovascular causes, nonfatal myocardial infarction, coronary-artery bypass grafting, percutaneous coronary intervention, nonfatal stroke, amputation, or surgery for peripheral atherosclerotic artery disease, P=0.007; †Unadjusted HR. CI = confidence interval; HR = hazard ratio. Gæde et al. N Engl J Med. 2003;348:383–393.

  38. Treating the Whole Patient: a 5.5-Year* Follow-up (Steno-2) Intensive Therapy Sustains Cardiovascular Benefits 80 HR 0.41 (95% CI, 0.25 to 0.67; P<0.001) 70 Conventional therapy 60 59% 50 Cumulative Incidence of Any Cardiovascular Event† (%) 40 30 Intensive therapy 20 10 0 0 1 2 3 4 5 6 7 8 9 10 11 12 13 Years of Follow-up *Mean. †Secondary composite endpoint of cardiovascular events, including death from cardiovascular causes, nonfatal stroke, nonfatal myocardial infarction, coronary-artery bypass grafting, percutaneous coronary intervention, revascularization for peripheral atherosclerotic artery disease, and amputation. Gæde et al. N Engl J Med. 2008;358:580–591.

  39. Management of Type 2 Diabetes • Type 2 diabetes requires a multifactorial approach for the management of glucose levels, blood pressure, and lipids to reduce complications1 • Recommendations for type 2 diabetes: *High risk patients are those with acute coronary syndromes or previous cardiovascular events. AACE = American Association of Clinical Endocrinologists; ACE = American College of Endocrinology; ADA = American Diabetes Association; EASD = European Association for the Study of Diabetes; HDL = high-density lipoprotein; LDL = low-density lipoprotein. 1. ADA Standards of Medical Care in Diabetes – 2009. Diabetes Care. 2009;32:S13–S61. 2. American Association of Clinical Endocrinologists. Endocrine Practice. 2007;13(suppl 1):3–68.

  40. Summary of Treatment Goals and Strategies • Glycemic control is fundamental to the management of diabetes1 • The UKPDS demonstrated significant risk reductions in microvascular complications in type 2 diabetes with more intensive glycemic control. The benefit of A1C–lowering to reduce CVD in type 2 diabetes is supported by UKPDS data2 • There is a need to treat the whole patient, including management of hyperglycemia, CV risk factors and other comorbidities. This is key in reducing diabetes-related complications3 1. AACE. Endocr Pract. 2007;13(suppl 1):4–68. 2. Stratton IM et al. BMJ. 2000;321:405–412. 3. American Diabetes Association. Diabetes Care. 2008;31(suppl 1):S12–S54.

  41. Conclusions:Management of Type 2 Diabetes • Diabetes is a major clinical problem • Pathophysiology involves insulin resistance and beta-cell dysfunction1 • Diabetes is correlated with increased risk of microvascular and macrovascular diseases and events • Microvascular complications are predominately driven by hyperglycemia2,3 • Macrovascular complications are multifactorial and complex4 1. Kahn SE. J Clin Endocrinol Metab. 2001;86:4047–4058. 2. AACE. Endocr Pract. 2007;13(suppl 1):4–68. 3. Stratton IM et al. BMJ. 2000;321:405–412. 4. American Diabetes Association. Diabetes Care. 2008;31(suppl 1):S12–S54.

  42. Conclusions:Management of Type 2 Diabetes (cont) • A1C reduction has been shown to reduce the risk of microvascular complications and may contribute to risk reduction of macrovascular endpoints1 • Early intervention is needed to get A1C to goal (diet and exercise should always be recommended)2 • It is challenging to maintain A1C control over time with traditional monotherapies3 • AACE and ADA* guidelines recommends use of combination therapy to achieve and sustain glycemic goals2,4 *ADA guidelines recommend that a second medication should be added within 3 months if patients are not at goal. 1. Stratton IM et al. BMJ. 2000;321:405–412; 2. American Diabetes Association. Diabetes Care. 2008;31(suppl 1):S12–S54; 3. UKPDS. Lancet. 1998;352:854–865; 4. AACE. Endocr Pract. 2007;13(suppl 1):4–68.

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