Effect of metformin plus roziglitazone compared with metformin alone on glycaemic control in well-controlled Type 2 diabetes

Diabetic Medicine

Volumn 23, Issue 10, 2006, Pages 1069-1078

  Stewart, M W ^a   Cirkel, D T ^a   Furuseth, K ^b   Donaldson, J ^a   Biswas, N ^c   Starkie, M G ^a   Phenekos, C ^d   Hamann, A ^e  

^a GLAXOSMITHKLINE   (United Kingdom)

^b Solli Klinikk ^*  (Norway)

^c GLAXOSMITHKLINE   (United States)

^d Nephrology Department of Korgialenio Benakio Hospital   (Greece)

^e UNIVERSITY HOSPITAL HEIDELBERG   (Germany)

Author keywords

Avandamet; Glycaemic control; HbA1c targets; Metformin; Type 2 diabetes

Indexed keywords

C REACTIVE PROTEIN; GLUCOSE; HEMOGLOBIN A1C; METFORMIN; METFORMIN PLUS ROSIGLITAZONE; PLACEBO;

ABDOMINAL PAIN; ADULT; AGED; ANGINA PECTORIS; ARTICLE; CELL FUNCTION; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIARRHEA; DOUBLE BLIND PROCEDURE; DRUG TOLERABILITY; EDEMA; FEMALE; GASTROINTESTINAL SYMPTOM; GLUCOSE BLOOD LEVEL; GLUCOSE HOMEOSTASIS; GLYCEMIC CONTROL; HEART INFARCTION; HEART MUSCLE ISCHEMIA; HUMAN; HYPOGLYCEMIA; INSULIN SENSITIVITY; ISCHEMIC HEART DISEASE; MAJOR CLINICAL STUDY; MALE; MONOTHERAPY; MULTICENTER STUDY; NON INSULIN DEPENDENT DIABETES MELLITUS; PANCREAS ISLET BETA CELL; RANDOMIZED CONTROLLED TRIAL; SHORT COURSE THERAPY; STATISTICAL SIGNIFICANCE; SYSTOLIC BLOOD PRESSURE;

BLOOD GLUCOSE; DIABETES MELLITUS, TYPE 2; DOUBLE-BLIND METHOD; DRUG THERAPY, COMBINATION; FEMALE; HUMANS; HYPOGLYCEMIC AGENTS; MALE; METFORMIN; MIDDLE AGED; THIAZOLIDINEDIONES;

EID: 33748741537     PISSN: 07423071     EISSN: 14645491     Source Type: Journal    
DOI: 10.1111/j.1464-5491.2006.01942.x     Document Type: Article

References (49)

1. Skyler JS. Diabetic complications. The importance of glucose control. Endocrinol Metabolism Clinics North America 1996; 25: 243-254.
2. American Diabetes Association. Standards of medical care in diabetes. Diabetes Care 2004; 27: S15-S34.
3. American Association of Clinical Endocrinologists. Medical guidelines for the management of diabetes mellitus: the AACE system of intensive diabetes self-management - 2002 update. Endocr Pract 2002; 8: 40-82.
4. European Diabetes Policy Group. A desktop guide to Type 2 diabetes. Diabet Med 1999; 16: 716-730.
5. Canadian Diabetes Association. Canadian Diabetes Association 2003 clinical practice guidelines for the prevention and management of diabetes in Canada. Can J Diabetes 2003; 27: S1-S152.
6. Latin American Diabetes Association (ALAD). Guidelines for the diagnosis, control and treatment of type 2 diabetes mellitus. Revista la Asociacion Latinoamericana Diabetes 2000; 8: 101-167.
7. Asian-Pacific Type 2 Diabetes Policy Group. Type 2 Diabetes: Practical Targets and Treatments, 3rd edn. Sydney, Australia: Health Communications Australia Pty Limited and In Vivo Communications Pty Limited. Available from: http://www.wpdd.org/
8. UK Prospective Diabetes Study (UKPDS) Group. Effect of intensive blood-glucose control with metformin on complications in overweight patients with type 2 diabetes (UKPDS 34). Lancet 1998; 352: 854-865.
9. UK Prospective Diabetes Study (UKPDS) Group. Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33). Lancet 1998; 352: 837-853.
10. Ohkubo Y, Kishikawa H, Araki E, Miyata T, Isami S, Motoyoshi S et al. Intensive insulin therapy prevents the progression of diabetic microvascular complications in Japanese patients with non-insulin-dependent diabetes mellitus: a randomized prospective 6-year study. Diabetes Res Clin Pract 1995; 28: 103-117.
11. Hellman R, Regan J, Rosen H. Effect of intensive treatment of diabetes on the risk of death or renal failure in NIDDM and IDDM. Diabetes Care 1997; 20: 258-264.
12. Stratton IM, Adler AI, Neil HA, Matthews DR, Manley SE, Cull CA et al. Association of glycaemia with macrovascular and microvascular complications of type 2 diabetes (UKPDS 35): prospective observation study. Br Med J 2000; 321: 405-412.
13. Saydah SH, Fradkin J, Cowie CC. Poor control of risk factors for vascular disease among adults with previously diagnosed diabetes. J Am Med Assoc 2004; 291: 335-342.
14. Liebl A, Mata M, Eschwege E. Evaluation of risk factors for development of complications in Type II diabetes in Europe. Diabetologia 2002; 45: S23-S28.
15. DeFronzo RA. Pharmacological therapy for type 2 diabetes mellitus. Ann Intern Med 1999; 131: 281-303.
16. Davidson MB, Peters AL. An overview of metformin in the treatment of type 2 diabetes mellitus. Am J Med 1997; 102: 99-110.
17. Diamant M, Heine RJ. Thiazolidinediones in type 2 diabetes mellitus: current clinical evidence. Drugs 2003; 63: 1373-1405.
18. Charbonnel B, Lonnqvist F, Jones NP, Abel MG, Patwardhan R. Rosiglitazone is superior to glyburide in reducing fasting plasma glucose after 1 year of treatment in Type 2 diabetic patients. Diabetes 1999; 48: A114.
19. Wolffenbuttel BHR, Gomist R, Squatrito S, Jones NP, Patwardham R. Addition of low-dose rosiglitazone to sulphonylurea therapy improves glycaemic control in Type 2 diabetic patients. Diabet Med 2000; 17: 40-47.
20. Fonseca V, Rosenstock J, Patwardhan R, Salzman A. Effect of metformin and rosiglitazone combination therapy in patients with type 2 diabetes mellitus: a randomised controlled trial. J Am Med Assoc 2000; 283: 1695-1702.
21. Bailey CJ, Del Prato S, Eddy D, Zinman B. on behalf of the Global Partnership for Effective Diabetes Management. Earlier intervention in type 2 diabetes: the case for achieving early and sustained glycaemic control. Int J Clin Pract 2005; 59: 1309-1316.
22. Del Prato S, Felton A-M, Munro N, Nesto R, Zimmet P, Zinman B. on behalf of the Global Partnership for Effective Diabetes Management. Improving glucose management: ten steps to get more patients with type 2 diabetes to glycaemic goal. Int J Clin Pract 2005; 59: 1345-1355.
23. World Health Organization. Definition, diagnosis and classification of diabetes mellitus and its complications. Part I. Diagnosis and classification of diabetes mellitus. Geneva: Department of Noncommunicable Disease Surveillance, World Health Organization, 1999.
24. Matthews DR, Hosker JP, Rudenski AS, Naylor BA, Treacher DF, Turner RC. Homeostasis model assessment: insulin resistance and β-cell function from fasting plasma glucose and insulin concentrations in man. Diabetologia 1985; 28: 412-419.
25. Friedewald WT, Levy RI, Fredrickson DS. Estimation of the concentration of low-density lipoprotein cholesterol in plasma, without use of the preparative ultracentrifuge. Clin Chem 1972; 18: 499-502.
26. Bailey CJ, Day C. Avandamet: combined metformin-rosiglitazone treatment for insulin resistance in type 2 diabetes. Int J Clin Pract 2004; 58: 867-876.
27. Dostou J, Islam N, Meyer C, Woerle H, Sparks C, Sparks J et al. Mechanisms by which RSG improves glycemic control in Type 2 DM. Diabetes 2001; 50: A2161.
28. Gerstein HC, Yusuf S, Holman R et al. Rationale, design and recruitment characteristics of a large, simple international trial of diabetes prevention: THE DREAM trial investigators. Diabetologia 2004; 47: 1519-1527.
29. Viberti G, Kahn SE, Greene DA et al. A diabetes outcome progression trial (ADOPT): An international multicentre study of the comparative efficacy of rosiglitazone, glyburide, and metformin in recently diagnosed type 2 diabetes. Diabetes Care 2002; 25: 1737-1743.
30. Gray RP, Yudkin JS. Cardiovascular disease in diabetes mellitus. In: Pickup JC, Williams G. eds. Textbook of Diabetes, 2nd edn. Oxford: Blackwell Sciences Ltd, 1997: 57.1-57.22.
31. Viberti GC. Rosiglitazone: potential beneficial impact on cardiovascular disease. Int J Clin Prac 2003; 57: 128-134.
32. Verges BL. Dyslipidaemia in diabetes mellitus. Diabetes Metab (Paris) 1999; 25: 32-40.
33. Cullen P, Von Eckardstein A, Souris S, Schulte H, Assmann G. Dyslipidemia and cardiovascular risk in diabetes. Diabetes, Obesity Metab 1999; 1: 189-198.
34. Best JD, O'Neal DN. Diabetic dyslipidemia. Drug 2000; 59: 1101-1111.
35. Arner P. Free fatty acids - do they play a critical role in type 2 diabetes? Diabetes, Obesity Metab 2001; 3: S11-S19.
36. Del Prato S, Volpe L. Rosiglitazone plus metformin: combination therapy for type 2 diabetes. Expert Opin Pharmacother 2004; 5: 1411-1422.
37. Phillips LS, Grunberger G, Miller E, Patwardhan R, Rappaport EB, Salzman A. Once and twice daily dosing with rosiglitazone improves glycaemic control in patients with type 2 diabetes. Diabetes Care 2001; 24: 308-315. Erratum: Diabetes Care 2001; 24: 973.
38. Weissman P, Goldstein BJ, Rosenstock J, Waterhouse B, Cobitz AR, Wooddell MJ et al. Effects of rosiglitazone added to sub-maximal doses of metformin compared with dose escalation of metformin in type 2 diabetes: the EMPIRE study. Curr Med Res Opin 2005; 21: 2029-2035.
39. Freed MI, Ratner R, Marcovina SM, Kreider MM, Biswas N, Cohen BR et al. Effects of rosiglitazone alone and in combination with atorvastatin on the metabolic abnormalities in type 2 diabetes mellitus. Am J Cardiol 2002; 90: 947-952.
40. Stevens RJ, Kothari V, Adler AI, Stratton IM, United Kingdom Prospective Diabetes Study (UKPDS) Group. The UKPDS risk engine: a model for the risk of coronary heart disease in type II diabetes (UKPDS 56). Clin Sci 2001; 101: 671-679.
41. UK Prospective Diabetes Study Group. Tight blood pressure control and risk of macrovascular and microvascular complications in type 2 diabetes: UKPDS 38. Br Med J 1998; 317: 703-713.
42. Heart Outcome Prevention Evaluation (Hope) Study Investigators. Effects of ramipril on cardiovascular and microvascular outcomes in people with diabetes mellitus: results of the HOPE study and MICRO-HOPE substudy. Lancet 2000; 355: 253-259.
43. Zanchetti A, Ruilope LM. Anti-hypertensive treatment in patients with type 2 diabetes mellitus: what guidance from recent controlled randomised trials? J Hypertension, 2002; 20: 2099-2110.
44. St John Sutton M, Rendell M, Dandona P, Dole JF, Murphy K, Patwardhan R et al. A comparison of the effects of rosiglitazone and glyburide on cardiovascular function and glycemic control in patients with type 2 diabetes. Diabetes Care 2002; 25: 2058-2064.
45. Oshinyemi K, Garcia S, Curtis P, Zambanini A, Stewart MW. Evaluation of the effects of rosiglitazone combination therapy on ambulatory blood pressure after 6 months; a 12-month substudy of the RECORD trial in people with Type 2 diabetes mellitus. Diabetelogia 2004; 47: A262.
46. Home P, Pocock S, Beck-Nielsen H, Gomis R, Hanefeld M, Dargie H et al. Rosiglitazone evaluated for cardiac outcomes and regulation of glycaemia in diabetes (RECORD): an interim analysis of glycaemia at 18 months. Diabetologia 2004; 47: A262.
47. Dormandy JA, Charbonnel B, Eckland DJA, Erdman E, Massi-Benedetti M, Moules IK et al. on behalf of the PRO Active Study Investigators. Secondary prevention of macrovascular events in patients with type 2 diabetes mellitus in the PRO-active study (PROspective pioglitazone clinical trial in macrovascular events): a randomised controlled trial. Lancet 2005; 366: 1279-1289.
48. Garber AJ, Duncan TG, Goodman AM, Mills DJ, Rohlf JL. Efficacy of metformin in type II diabetes: results of a double-blind, placebo-controlled, dose-response trial. Am J Med 1997; 103: 491-497.
49. AVANDAMET. Prescribing information. January 2005; AT: L7. Available from: http://www.thomsonhc.com/pdrel/librarian. Last accessed: 8 March 2006.