Effect of metformin and rosiglitazone combination therapy in patients with type 2 diabetes mellitus: A randomized controlled trial

JAMA

Volumn 283, Issue 13, 2000, Pages 1695-1702

  Fonseca, Vivian ^a   Rosenstock, Julio ^b   Patwardhan, Rita ^c   Salzman, Alan ^c  

^a TULANE UNIVERSITY SCHOOL OF MEDICINE   (United States)

^b Medical City Dallas   (United States)

^c GLAXOSMITHKLINE   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

GLYCOSYLATED HEMOGLOBIN; METFORMIN; PLACEBO; ROSIGLITAZONE;

ADULT; AGED; ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIARRHEA; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG MECHANISM; FEMALE; GLUCOSE BLOOD LEVEL; HEADACHE; HUMAN; INSULIN SENSITIVITY; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; NON INSULIN DEPENDENT DIABETES MELLITUS; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; TREATMENT INDICATION; UNITED STATES; UPPER RESPIRATORY TRACT INFECTION;

EID: 0034607438     PISSN: 00987484     EISSN: None     Source Type: Journal    
DOI: 10.1001/jama.283.13.1695     Document Type: Article

References (44)

1. DeFronzo R. Lilly Lecture 1987: the triumvirate: β-cell, muscle, liver. Diabetes. 1988;37:667-687.
2. The Expert Committee on the Diagnosis and Classification of Diabetes Mellitus. Report of the Expert Committee on the Diagnosis and Classification of Diabetes Mellitus. Diabetes Care. 1999;22(suppl 1):S5-S19.
3. Turner RC, Cull CA, Frighi V, Holman RR, for the UK Prospective Diabetes Study (UKPDS) Croup. Glycemic control with diet, sulfonylurea, metformin, or insulin in patients with type 2 diabetes mellitus. JAMA. 1999;281:2005-2012.
4. Lehmann JM, Moore LB, Smith-Oliver TA. An antidiabetic thiazolidinedione is a high affinity ligand for peroxisome proliferator-activated receptor gamma. J Biol Chem. 1995;270:12953-12956.
5. Saltiel AR, Olefsky JM. Thiazolidinediones in the treatment of insulin resistance and type 2 diabetes. Diabetes. 1996;45:1661-1669.
6. Smith SA, Cawthorne MA, Coyle PJ, et al. BRL 49653C normalizes glycemic control in Zucker fatty fa/fa rats by improving hepatic and peripheral tissue sensitivity to insulin. Diabetologia. 1993;36(suppl 1):A184.
7. Consoli A, Nurihan N, Capani F, Gerich J. Predominant role of gluconeogenesis in increased hepatic glucose production in NIDDM. Diabetes. 1989;38:550-557.
8. Stumvoll M, Nurjhan N, Perriello G. Metabolic effects of metformin in NIDDM. N Engl J Med. 1995;333:550-554.
9. Cusi K, Consoli A, DeFronzo RA. Metabolic effects of metformin on glucose and lactate metabolism in noninsulin-dependent diabetes mellitus. J Clin Endocrinol Metab. 1996;81:4059-4067.
10. Bailey CJ, Turner RC. Drug therapy: metformin. N Engl J Med. 1996;334:574-579.
11. 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.
12. National Diabetes Data Group. Classification and diagnosis of diabetes mellitus and other categories of glucose intolerance. Diabetes. 1979;28:1039-1057
13. Friedewald WT, Levy RI, Fredrickson DS. Estimation of the low-density lipoprotein cholesterol in plasma without use of the preparative ultracentrifuge. Clin Chem. 1972;18:499-502.
14. Emoto M, Nishizawa Y, Maekawa K, et al. Homeostasis model assessment as a clinical index of insulin resistance in type 2 diabetic patients treated with sulfonylureas. Diabetes Care. 1999;22:818-822.
15. Hermans MP, Levy JC, Morris RJ, Turner RC. Comparison of insulin sensitivity tests across a range of glucose tolerance from normal to diabetes. Diabetologia. 1999;42:678-687.
16. Matsuda M, DeFronzo RA. Insulin sensitivity indices obtained from oral glucose tolerance testing: comparison with the euglycemic insulin clamp. Diabetes Care. 1999;22:1462-1470.
17. Hermans MP, Levy JC, Morris RJ, Turner RC. Comparison of tests of β-cell function across a range of glucose tolerance from normal to diabetes. Diabetes. 1999;48:1779-1786.
18. United Kingdom Prospective Diabetes Study Group. United Kingdom Prospective Diabetes Study 24. Ann Intern Med. 1998;128:165-175.
19. Haffner SM, Miettenen H, Stern MP. The homeostasis model in the San Antonio Heart Study. Diabetes Care. 1997;20:1087-1092.
20. Inzucchi SE, Maggs DG, Spollett GR, et al. Efficacy and metabolic effects of metformin and troglitazone in type II diabetes mellitus. N Engl J Med. 1998;338:867-872.
21. Mooradian AD, Thurman JE. Drug therapy of postprandial hyperglycaemia. Drugs. 1999;57:19-29.
22. Raskin P, Rappaport EB, Cole ST, Yan Y, Patwardhan R, Freed MI. Rosiglitazone short-term monotherapy lowers fasting and post-prandial glucose in patients with type 2 diabetes. Diabetologia. In press.
23. Yamasaki Y, Kawamori R, Wasada T, et al. Rioglitazone (AD-4833) ameliorates insulin resistance in patients with NIDDM. Tohoku J Exp Med. 1997;183:173-183.
24. Mimura K, Umeda F, Hiramatsu S, et al. Effects of a new oral hypoglycaemic agent (CS-045) on metabolic abnormalities and insulin resistance in type 2 diabetes. Diabet Med. 1994;11:685-691.
25. Marshak S, Leibowitz C, Bertuzzi F, et al. Impaired beta-cell functions induced by chronic exposure of cultured human pancreatic islets to high glucose. Diabetes. 1999;48:1230-1236.
26. Paolisso G, Howard BV. Role of non-esterified fatty acids in the pathogenesis of type 2 diabetes mellitus. Diabet Med. 1998;15:360-366.
27. McGarry JD, Dobbins RL. Fatty acids, lipotoxicity and insulin secretion. Diabetologia. 1999;42:128-138.
28. Rubins HB, Robins SJ, Collins D, et al. Gemfibrozil for the secondary prevention of coronary heart disease in men with low levels of high-density lipoprotein cholesterol. N Engl J Med. 1999;341:410-418.
29. Criqui MH, Golomb BA. Epidemiologic aspects of lipid abnormalities. Am J Med. 1998;105:485-575.
30. Kinosian B, Glick H, Garland G. Cholesterol and coronary heart disease. Ann Intern Med. 1994;121:641-647.
31. Haffner SM, Lehto S, Ronnemaa T, Pyörälä K, Laakso M. Mortality from coronary heart disease in subjects with type 2 diabetes and in nondiabetic subjects with and without prior myocardial infarction. N Engl J Med. 1998;339:229-234.
32. Pyörälä K, Pedersen TR, Kjekshus J, Faergeman O, Olsson AG, Thorgeirsson G. Cholesterol lowering with simvastatin improves prognosis of diabetic patients with coronary heart disease. Diabetes Care. 1997;20:614-620.
33. Hermann LS, Melander A. Biguanides: basic aspects and clinical uses. In: Alberti KGMM, DeFronzo RA, eds. International Textbook of Diabetes Mellitus. Vol 1. Chichester, England: John Wiley & Sons Inc; 1992:773-795.
34. Bergman RN, Mittelman SD. Central role of the adipocyte in insulin resistance. J Basic Clin Physiol Pharmacol. 1998;9:205-221.
35. Steinberg HO, Tershoby M, Monestel R, et al. Elevated circulating free fatty acid levels impair endothelium-dependent vasodilation. J Clin Invest. 1997;100:1230-1239.
36. Fagot-Campagna A, Balkau B, Simon D, et al. High free fatty acid concentration: an independent risk factor for hypertension in the Paris Prospective Study. Int J Epidemiol. 1998;27:808-813.
37. Mitropoulos KA, Miller GJ, Watts GF, Durrington PN. Lipolysis of triglyceride-rich lipoproteins activates coagulant factor XII: a study in familial lipoprotein-lipase deficiency. Atherosclerosis. 1992;95:119-125.
38. Mikhailidis DP, Mahadevaiah S, Hutton RA, Georgiadis E, Cramp DG, Ginsburg J. Plasma non-esterified fatty acids and platelet aggregation. Thromb Res. 1983;32:641-643.
39. Day C. Thiazolidinediones: a new class of anti-diabetic drugs. Diabet Med. 1999;16:179-192.
40. Hallakou S, Doare L, Foufelle F, et al. Pioglitazone induces in vivo adipocyte differentiation in the obese Zucker fa/fa rat. Diabetes. 1997;46:1393-1399.
41. Young MM, Squassante L, Wemer J, van Marle SP, Dogterom P, Johnkman JH. Troglitazone has no effect on red cell mass or other erythropoietic parameters. Eur J Clin Pharmacol. 1999;55:101-104.
42. Shimizu H, Tsuchiya T, Sato N, ShimomuraY, Kobayashi I, Mori M. Troglitazone reduces plasma leptin concentration but increases hunger in NIDDM patients. Diabetes Care. 1998;21:1470-1474.
43. Seidell JC, Hautvast JG, Deurenberg P. Overweight: fat distribution and health risks. Infusions-therapie. 1989;16:276-281.
44. Dogterom P, Jonkman JHG, Vallance SE. Rosiglitazone: no effect on erythropoiesis or premature red cell destruction. Diabetes. 1999;48(suppl 1):A98.