Impact of data from recent clinical trials on strategies for treating patients with type 2 diabetes mellitus

Vascular Health and Risk Management

Volumn 6, Issue 1, 2010, Pages 17-26

  Palumbo, Pasquale J ^a   Wert, Jonathan M ^b  

^a MAYO CLINIC   (United States)

^b BlueSpark Healthcare Communications   (United States)

Author keywords

Cardiovascular disease; Diabetes treatment; Glucose control; Incretin based therapies; Type 2 diabetes

Indexed keywords

2,4 THIAZOLIDINEDIONE DERIVATIVE; ALPHA GLUCOSIDASE INHIBITOR; AMYLIN; AMYLIN DERIVATIVE; CHLORPROPAMIDE; DIPEPTIDYL PEPTIDASE IV INHIBITOR; EXENDIN 4; GLIBENCLAMIDE; GLIMEPIRIDE; GLUCAGON LIKE PEPTIDE 1 RECEPTOR AGONIST; GLYCOSYLATED HEMOGLOBIN; HEMOGLOBIN A1C; HORMONE RECEPTOR STIMULATING AGENT; INSULIN; LIRAGLUTIDE; MEGLITINIDE; METFORMIN; ORAL ANTIDIABETIC AGENT; PIOGLITAZONE; PLACEBO; PRAMLINTIDE; ROSIGLITAZONE; SAXAGLIPTIN; SITAGLIPTIN; SULFONYLUREA; UNCLASSIFIED DRUG;

CARDIOVASCULAR DISEASE; CLINICAL TRIAL; COMORBIDITY; CONGESTIVE HEART FAILURE; DIABETIC PATIENT; DIARRHEA; DISEASE DURATION; DRUG DOSE COMPARISON; DYSLIPIDEMIA; FLUID RETENTION; FRACTURE; GASTROINTESTINAL SYMPTOM; GLYCEMIC CONTROL; HEART INFARCTION; HUMAN; HYPERGLYCEMIA; HYPERTENSION; HYPOGLYCEMIA; INCIDENCE; INJECTION SITE PRURITUS; KIDNEY FAILURE; MORBIDITY; MORTALITY; NAUSEA; NON INSULIN DEPENDENT DIABETES MELLITUS; OBESITY; PANCREAS ISLET BETA CELL; PANCREATITIS; REVIEW; RISK FACTOR; SIDE EFFECT; TREATMENT PLANNING; VOMITING; WEIGHT GAIN; WEIGHT REDUCTION;

EID: 77950795096     PISSN: 11766344     EISSN: 11782048     Source Type: Journal    
DOI: 10.2147/vhrm.s8564     Document Type: Review

References (53)

1. Centers for Disease Control and Prevention. 2007 National Diabetes Fact Sheet. July 23, 2008. Available at http://www.cdc.gov/diabetes/pubs/estimates07.htm. Accessed September 10, 2009.
2. American Diabetes Association. Standards of medical care in diabetes - 2009. Diabetes Care. 2009;32 Suppl 1:S13-S61.
3. Lloyd-Jones D, Adams R, Carnethon M, et al. Heart disease and stroke statistics - 2009 update: a report from the American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Circulation. 2009;119(3):480-486.
4. Eeg-Olofsson K, Cederholm J, Nilsson PM, et al. Risk of cardiovascular disease and mortality in overweight and obese patients with type 2 diabetes: an observational study in 13,087 patients. Diabetologia. 2009;52(1):65-73.
5. Rodbard HW, Blonde L, Braithwaite SS, et al. American Association of Clinical Endocrinologists medical guidelines for clinical practice for the management of diabetes mellitus. Endocr Pract. 2007;13 Suppl 1:1-68.
6. 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):773-795.
7. International Diabetes Center. Treatment algorithm for glucose control in type 2 diabetes: IDC treatment of type 2 diabetes: Glycemic control. Available at http://www.parknicollet.com/diabetes/profServices/ algorithm.cfm. Accessed September 10, 2009.
8. Nathan DM, Buse JB, Davidson MB, et al. Medical management of hyperglycemia in type 2 diabetes: a consensus algorithm for the initiation and adjustment of therapy: a consensus statement of the American Diabetes Association and the European Association for the Study of Diabetes. Diabetes Care. 2009;32(1):193-203.
9. Gerstein HC, Miller ME, Byington RP, et al; for the Action to Control Cardiovascular Risk in Diabetes (ACCORD) Study Group. Effects of intensive glucose lowering in type 2 diabetes. N Engl J Med. 2008;358(24):2545-2559.
10. Patel A, MacMahon S, Chalmers J, et al; for the Action in Diabetes and Vascular Disease: Preterax and Diamicron Modified Release and Controlled Evaluation (ADVANCE) Collaborative Group. Intensive blood glucose control and vascular outcomes in patients with type 2 diabetes. N Engl J Med. 2008;358(24):2560-2572.
11. Duckworth W, Abraira C, Moritz T, et al. Glucose control and vascular complications in veterans with type 2 diabetes. N Engl J Med. 2009; 360(2):129-139.
12. Gaede P, Lund-Andersen H, Parving HH, Pedersen O. Effect of a multifactorial intervention on mortality in type 2 diabetes. N Engl J Med. 2008;358(6):580-591.
13. Skyler JS, Bergenstal R, Bonow RO, et al. Intensive glycemic control and the prevention of cardiovascular events: implications of the ACCORD, ADVANCE, and VA diabetes trials: a position statement of the American Diabetes Association and a scientific statement of the American College of Cardiology Foundation and the American Heart Association. Diabetes Care. 2009;32(1): 187-192.
14. Skyler JS. Diabetic complications. The importance of glucose control. Endocrinol Metab Clin North Am. 1996;25(2):243-254.
15. Nathan DM, Cleary PA, Backlund JY, et al; for the Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications (DCCT/EDIC) Study Research Group. Intensive diabetes treatment and cardiovascular disease in patients with type 1 diabetes. N Eng J Med. 2005;353(25):2643-2653.
16. Klein R, Knudtson MD, Lee KE, Gangnon R, Klein BE. The Wisconsin Epidemiologic Study of Diabetic Retinopathy XXIII: the twenty-fiveyear incidence of macular edema in persons with type 1 diabetes. Ophthalmology. 2009;116(3):497-503.
17. Hirai FE, Knudtson MD, Klein BE, Klein R. Clinically significant macular edema and survival in type 1 and type 2 diabetes. Am J Ophthalmol. 2008;145(4):700-706.
18. Klein R, Klein BE, Moss SE, Wong TY. Retinal vessel caliber and microvascular and macrovascular disease in type 2 diabetes: XXI: the Wisconsin Epidemiologic Study of Diabetic Retinopathy. Ophthalmology. 2007;114(10):1884-1892.
19. Holman RR, Paul SK, Bethel MA, Matthews DR, Neil HA. 10-year follow-up of intensive glucose control in type 2 diabetes. N Engl J Med. 2008;359(15):1577-1589.
20. Holman RR, Paul SK, Bethel MA, Neil HA, Matthews DR. Long-term follow-up after tight control of blood pressure in type 2 diabetes. N Engl J Med. 2008;359(15):1565-1576.
21. Pi-Sunyer X, Blackburn G, Brancati FL, et al. Reduction in weight and cardiovascular disease risk factors in individuals with type 2 diabetes: one-year results of the look AHEAD trial. Diabetes Care. 2007;30(6):1374-1383.
22. Fox CS, Pencina MJ, Wilson PW, Paynter NP, Vasan RS, D'Agostino RB Sr. Lifetime risk of cardiovascular disease among individuals with and without diabetes stratified by obesity status in the Framingham heart study. Diabetes Care. 2008;31(8): 1582-1584.
23. Malmberg K. Role of insulin-glucose infusion in outcomes after acute myocardial infarction: the diabetes and insulin-glucose infusion in acute myocardial infarction (DIGAMI) study. Endocr Pract. 2004;10 Suppl 2: 13-16.
24. Mellbin LG, Malmberg K, Norhammar A, Wedel H, Ryden L. The impact of glucose lowering treatment on long-term prognosis in patients with type 2 diabetes and myocardial infarction: a report from the DIGAMI 2 trial. Eur Heart J. 2008;29(2):166-176.
25. Mellbin LG, Malmberg K, Waldenstrom A, Wedel H, Ryden L. Prognostic implications of hypoglycaemic episodes during hospitalisation for myocardial infarction in patients with type 2 diabetes: a report from the DIGAMI 2 trial. Heart. 2009;95(9):721-727.
26. Aas AM, Ohrvik J, Malmberg K, Ryden L, Birkeland KI. Insulin-induced weight gain and cardiovascular events in patients with type 2 diabetes. A report from the DIGAMI 2 study. Diabetes Obes Metab. 2009;11(4):323-329.
27. BARI 2D Study Group. Baseline characteristics of patients with diabetes and coronary artery disease enrolled in the Bypass Angioplasty Revascularization Investigation 2 Diabetes (BARI 2D) trial. Am Heart J. 2008;156(3):528-536.
28. Frye RL, August P, Brooks MM, et al; BARI 2D Study Group. A randomized trial of therapies for type 2 diabetes and coronary artery disease. N Engl J Med. 2009;360(24):2503-2515.
29. Purnell JQ, Weyer C. Weight effect of current and experimental drugs for diabetes mellitus: from promotion to alleviation of obesity. Treat Endocrinol. 2003;2(1):33-47.
30. Henry RR. Evolving concepts of type 2 diabetes management with oral medications: new approaches to an old disease. Curr Med Res Opin. 2008;24(8):2189-2202.
31. Edelman SV. Optimizing diabetes treatment using an amylin analogue. Diabetes Educ. 2008; 34 Suppl 1: 4S-10S.
32. Hollander PA, Levy P, Fineman MS, et al. Pramlintide as an adjunct to insulin therapy improves long-term glycemic and weight control in patients with type 2 diabetes: a 1-year randomized controlled trial. Diabetes Care. 2003;26(3):784-790.
33. Hoogwerf BJ, Doshi KB, Diab D. Pramlintide, the synthetic analogue of amylin: physiology, pathophysiology, and effects on glycemic control, body weight, and selected biomarkers of vascular risk. Vasc Health Risk Manag. 2008;4(2):355-362.
34. Riddle M, Frias J, Zhang B, et al. Pramlintide improved glycemic control and reduced weight in patients with type 2 diabetes using basal insulin. Diabetes Care. 2007;30(11):2794-2799.
35. Nauck MA, Homberger E, Siegel EG, et al. Incretin effects of increasing glucose loads in man calculated from venous insulin and C-peptide responses. J Clin Endocrinol Metab. 1986;63(2):492-498.
36. Drucker DJ, Nauck MA. The incretin system: glucagon-like peptide-1 receptor agonists and dipeptidyl peptidase-4 inhibitors in type 2 diabetes. Lancet. 2006;368(9548):1696-1705.
37. Deacon CF, Nauck MA, Toft-Nielsen M, Pridal L, Willms B, Holst JJ. Both subcutaneously and intravenously administered glucagon-like peptide I are rapidly degraded from the NH2-terminus in type II diabetic patients and in healthy subjects. Diabetes. 1995;44(9): 1126-1131.
38. Eng J, Kleinman WA, Singh L, Singh G, Raufman JP. Isolation and characterization of exendin-4, an exendin-3 analogue, from Heloderma suspectum venom. Further evidence for an exendin receptor on dispersed acini from guinea pig pancreas. J Biol Chem. 1992;267(11):7402-7405.
39. Klonoff DC, Buse JB, Nielsen LL, et al. Exenatide effects on diabetes, obesity, cardiovascular risk factors and hepatic biomarkers in patients with type 2 diabetes treated for at least 3 years. Curr Med Res Opin. 2008;24(1):275-286.
40. Bunck MC, Diamant M, Corner A, et al. One-year treatment with exenatide improves beta-cell function, compared with insulin glargine, in metformin-treated type 2 diabetic patients: a randomized, controlled trial. Diabetes Care. 2009;32(5):762-768.
41. Bhushan R, Elkind-Hirsch KE, Bhushan M, Butler WJ, Duncan K, Marrioneaux O. Exenatide use in the management of metabolic syndrome: a retrospective database study. Endocr Pract. 2008;14(8):993-999.
42. Maggs D, Bhole D, Yan P, Stonehouse A, Brodows R, Okerson T. Exenatide is superior to insulin in attaining tight glycaemic control (A1C {eth}c 6.5%) with a more favorable accompanying metabolic profile. Presented at the 44th Annual Meeting of the European Association for the Study of Diabetes; September 7.11, 2008; Rome, Italy. Abstract 876.
43. Okerson T, Yan P, Stonehouse A, Brodows R, Bhole D. Exenatide improved systolic blood pressure compared to insulin or placebo in patients with type 2 diabetes. Presented at the 44th Annual Meeting of the European Association for the Study of Diabetes; September 7.11, 2008; Rome, Italy. Abstract 877.
44. Drucker DJ, Buse JB, Taylor K, et al. Exenatide once weekly versus twice daily for the treatment of type 2 diabetes: a randomised, openlabel, non-inferiority study. Lancet. 2008;372(9645):1240.1250.
45. Nauck M, Frid A, Hermansen K, et al. Efficacy and safety comparison of liraglutide, glimepiride, and placebo, all in combination with metformin, in type 2 diabetes: the LEAD (liraglutide effect and action in diabetes)-2 study. Diabetes Care. 2009;32(1):84-90.
46. Garber A, Henry R, Ratner R, et al. Liraglutide versus glimepiride monotherapy for type 2 diabetes (LEAD-3 Mono): a randomised, 52-week, phase III, double-blind, parallel-treatment trial. Lancet. 2009; 373 (9662): 473-481.
47. Herman GA, Bergman A, Stevens C, et al. Effect of single oral doses of sitagliptin, a dipeptidyl peptidase-4 inhibitor, on incretin and plasma glucose levels after an oral glucose tolerance test in patients with type 2 diabetes. J Clin Endocrinol Metab. 2006; 91 (11): 4612-4619.
48. Aschner P, Kipnes MS, Lunceford JK, Sanchez M, Mickel C, Williams- Herman DE. Effect of the dipeptidyl peptidase-4 inhibitor sitagliptin as monotherapy on glycemic control in patients with type 2 diabetes. Diabetes Care. 2006; 29 (12): 2632-2637.
49. Charbonnel B, Karasik A, Liu J, Wu M, Meininger G. Efficacy and safety of the dipeptidyl peptidase-4 inhibitor sitagliptin added to ongoing metformin therapy in patients with type 2 diabetes inadequately controlled with metformin alone. Diabetes Care. 2006; 29 (12): 2638-2643.
50. Rosenstock J, Brazg R, Andryuk PJ, Lu K, Stein P. Efficacy and safety of the dipeptidyl peptidase-4 inhibitor sitagliptin added to ongoing pioglitazone therapy in patients with type 2 diabetes: a 24-week, multicenter, randomized, double-blind, placebo-controlled, parallel-group study. Clin Ther. 2006; 28 (10): 1556-1568.
51. Rosenstock J, Aguilar-Salinas C, Klein E, Nepal S, List J, Chen R; for the CV181-011 Study Investigators. Effect of saxagliptin monotherapy in treatment-naive patients with type 2 diabetes. Curr Med Res Opin. 2009;25(10):2401-2411.
52. Chacra A, Tan G, Apanovitch A, Ravichandran S, List J, Chen R. Saxagliptin added to a submaximal dose of sulphonylurea improves glycaemic control compared with uptitration of sulphonylurea in patients with type 2 diabetes: a randomized controlled trial. Int J Clin Pract. 2009;63(9):1395.1406.
53. Jadzinsky M, Pfutzner A, Paz-Pacheco E, Xu Z, Allen E, Chen R; for the CV181-039 Investigators. Saxagliptin given in combination with metformin as initial therapy improves glycemic control in patients with type 2 diabetes compared with either monotherapy: a randomized controlled trial. Diab Obese Metab. 2009; (6): 611-622.