Combination therapy with rosiglitazone and glibenclamide compared with upward titration of glibenclamide alone in patients with type 2 diabetes mellitus

Diabetes Research and Clinical Practice

Volumn 63, Issue 3, 2004, Pages 213-223

  Kerenyi, Zsuzsa ^a   Samer, Holger ^b   James, Rachel ^c   Yan, Ying ^d   Stewart, Murray ^c  

^a Szent Imre Hospital   (Hungary)

^b GlaxoSmithKline Pharmaceuticals ^*  (Germany)

^c GLAXOSMITHKLINE   (United Kingdom)

^d GLAXOSMITHKLINE   (United States)

Author keywords

Combination therapy; Glibenclamide; Rosiglitazone; Sulphonylureas; Thiazolidinediones

Indexed keywords

CHOLESTEROL; GLIBENCLAMIDE; HEMOGLOBIN A1C; ROSIGLITAZONE; TRIACYLGLYCEROL;

AGED; ARTICLE; CHOLESTEROL BLOOD LEVEL; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; DRUG EFFECT; DRUG MECHANISM; DRUG SAFETY; DRUG TOLERANCE; FEMALE; HUMAN; HYPOGLYCEMIA; INSULIN SENSITIVITY; MAJOR CLINICAL STUDY; MALE; MONOTHERAPY; NON INSULIN DEPENDENT DIABETES MELLITUS; PANCREAS ISLET BETA CELL; RANDOMIZATION; RANDOMIZED CONTROLLED TRIAL; TITRIMETRY; TRIACYLGLYCEROL BLOOD LEVEL;

EID: 0942300619     PISSN: 01688227     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.diabres.2003.09.009     Document Type: Article

References (37)

1. 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). UK Prospective Diabetes Study (UKPDS) Group, Lancet 352 (1998) 837-853.
2. Holman R.R. Assessing the potential for alpha-glucosidase inhibitors in prediabetic states. Diabetes Res. Clin. Pract. 40:1998;S21-S25.
3. Stenman S., Melander A., Groop P.H., Groop L.C. What is the benefit of increasing the sulfonylurea dose. Ann. Int. Med. 118:1993;169-172.
4. Groop L.C. Sulfonylureas in NIDDM. Diabetes Care. 15:1992;737-754.
5. Groop L.C., Barzilai N., Ratheiser K., Luzi L., Wahlin-Boll E., Melander A., DeFronzo R.A. Dose-dependent effects of glyburide on insulin secretion and glucose uptake in humans. Diabetes Care. 14:1991;724-727.
6. Groop L., Groop P.H., Stenman S., Saloranta C., Totterman K.J., Fyhrquist F.et al. Comparison of pharmacokinetics, metabolic effects and mechanisms of action of glyburide and glipizide during long-term treatment. Diabetes Care. 10:1987;71-78.
7. Miyazaki Y., Glass L., Triplitt C., Matsuda M., Cusi K., Mahankali A.et al. Effect of rosiglitazone on glucose and non-esterified fatty acid metabolism in Type II diabetic patients. Diabetologia. 44:2001;2210-2219.
8. Mayerson A.B., Hundal R.S., Dufour S., Lebon V., Befroy D., Cline G.W.et al. The effects of rosiglitazone on insulin sensitivity, lipolysis, and hepatic and skeletal muscle triglyceride content in patients with type 2 diabetes. Diabetes. 51:2002;797-802.
9. Hallsten K., Virtanen K.A., Lonnqvist F., Sipila H., Oksanen A., Viljanen T.et al. Rosiglitazone but not metformin enhances insulin- and exercise-stimulated skeletal muscle glucose uptake in patients with newly diagnosed type 2 diabetes. Diabetes. 51:2002;3479-3485.
10. Lebovitz H.E., Dole J.F., Patwardhan R., Rappaport E.B., Freed M.I. Rosiglitazone monotherapy is effective in patients with type 2 diabetes. J. Clin. Endocrinol. Metab. 86:2001;280-288.
11. Wolffenbuttel B.H., Gomis R., Squatrito S., Jones N.P., Patwardhan R.N. Addition of low-dose rosiglitazone to sulphonylurea therapy improves glycaemic control in Type 2 diabetic patients. Diab. Med. 17:2000;40-47.
12. Fonseca V., Rosenstock J., Patwardhan R., Salzman A. Effect of metformin and rosiglitazone combination therapy in patients with type 2 diabetes mellitus: a randomized controlled trial. J. Am. Med. Assoc. 283:2000;1695-1702.
13. Raskin P., Rendell M., Riddle M.C., Dole J.F., Freed M.I., Rosenstock J. A randomized trial of rosiglitazone therapy in patients with inadequately controlled insulin-treated type 2 diabetes. Diabetes Care. 24:2001;1226-1232.
14. Alberti K.G., Zimmet P.Z. Definition, diagnosis and classification of diabetes mellitus and its complications. Part 1. Diagnosis and classification of diabetes mellitus provisional report of a WHO consultation. Diab. Med. 15:1998;539-553.
15. Friedewald W.T., Levy R.I., Fredrickson D.S. Estimation of the concentration of low-density lipoprotein cholesterol in plasma, without use of the preparative ultracentrifuge. Clin. Chem. 18:1972;499-502.
16. Levy J.C., Matthews D.R., Hermans M.P. Correct homeostasis model assessment (HOMA) evaluation uses the computer program. Diabetes Care. 21:1998;2191-2192.
17. Wåhlin-Boll E., Sartor G., Melander A., Scherstén B. Impaired effect of sulfonylurea following increased dosage. Eur. J. Clin. Pharmacol. 22:1982;21-25.
18. Viberti G., Kahn S.E., Greene D.A., Herman W.H., Zinman B., Holman R.R., Haffner S.M., Levy D., Lachin J.M., Berry R.A., Heise M.A., Jones N.P., Freed M.I. A diabetes outcome progression trial (ADOPT): an international multicenter study of the comparative efficacy of rosiglitazone, glyburide, and metformin in recently diagnosed type 2 diabetes. Diabetes Care. 25:2002;1737-1743.
19. UK prospective diabetes study 16. Overview of 6 years' therapy of type II diabetes: a progressive disease. UK Prospective Diabetes Study Group. Diabetes 44 (1995) 1249-1258.
20. Haffner S.M., Howard G., Mayer E., Bergman R.N., Savage P.J., Rewers M. et al. Insulin sensitivity and acute insulin response in African-Americans, non-Hispanic whites, and Hispanics with NIDDM: the Insulin Resistance Atherosclerosis Study. Diabetes. 46:1997;63-69.
21. Viberti G.C. Rosiglitazone: potential beneficial impact on cardiovascular disease. Int. J. Clin. Pract. 57:2003;128-134.
22. Freed M.I., Ratner R., Marcovina S.M., Kreider M.M., Biswas N., Cohen B.R. Effects of rosiglitazone alone and in combination with atorvastatin on the metabolic abnormalities in type 2 diabetes mellitus. Am. J. Cardiol. 90:2002;947-952.
23. Austin M.A., Breslow J.L., Hennekens C.H., Buring J.E., Willett W.C., Krauss R.M. Low-density lipoprotein subclass patterns and risk of myocardial infarction. J. Am. Med. Assoc. 260:1988;1917-1921.
24. Singh T., Singh S., Bhullar G.S. The effect of sulphonylurea therapy on serum total cholesterol and high density lipoprotein cholesterol. J. Indian Med. Assoc. 90:1992;259-261.
25. Baynes C., Elkeles R.S., Henderson A.D., Richmond W., Johnston D.G. The effects of glibenclamide on glucose homeostasis and lipoprotein metabolism in poorly controlled type 2 diabetes. Horm. Metab Res. 25:1993;96-101.
26. Takami K., Takeda N., Nakashima K., Takami R., Hayashi M., Ozeki S. Effects of dietary treatment alone or diet with voglibose or glyburide on abdominal adipose tissue and metabolic abnormalities in patients with newly diagnosed type 2 diabetes. Diabetes Care. 25:2002;658-662.
27. Boden G. Effects of free fatty acids (FFA) on glucose metabolism: significance for insulin resistance and Type 2 diabetes. Exp. Clin. Endocrinol. Diabetes. 111:2003;121-124.
28. Boden G., Lebed B., Schatz M., Homko C., Lemieux S. Effects of acute changes of plasma free fatty acids on intramyocellular fat content and insulin resistance in healthy subjects. Diabetes. 50:2001;1612-1617.
29. Lam T.K., Carpentier A., Lewis G.F., van de W.G., Fantus I.G., Giacca A. Mechanisms of the free fatty acid-induced increase in hepatic glucose production. Am. J. Physiol. Endocrinol. Metab. 284:2003;E863-E873.
30. Carpentier A., Mittelman S.D., Lamarche B., Bergman R.N., Giacca A., Lewis G.F. Acute enhancement of insulin secretion by FFA in humans is lost with prolonged FFA elevation. Am. J. Physiol. 276:1999;E1055-E1066.
31. Paolisso G., Tagliamonte M.R., Rizzo M.R., Gualdiero P., Saccomanno F., Gambardella A.et al. Lowering fatty acids potentiates acute insulin response in first degree relatives of people with type II diabetes. Diabetologia. 41:1998;127-1132.
32. Wilmsen H.M., Ciaraldi T.P., Carter L., Reehman N., Mudaliar S.R., Henry R.R. Thiazolidinediones upregulate impaired fatty acid uptake in skeletal muscle of type 2 diabetic subjects. Am. J. Physiol. Endocrinol. Metab. 285:2003;E354-E362.
33. Glasmacher A.G., Brennemann W., Hahn C., Marko C., Wehnert S., Lohr U., Kutschkow R. Evaluation of five devices for self-monitoring of blood glucose in the normoglycaemic range. Exp. Clin. Endocrinol. Diabetes. 106:1998;360-364.
34. Trajanoski Z., Brunner G.A., Gfrerer R.J., Wach P., Pieber T.R. Accuracy of home blood glucose meters during hypoglycemia. Diabetes Care. 19:1996;1412-1415.
35. Loi C.M., Young M., Randinitis E., Vassos A., Koup J.R. Clinical pharmacokinetics of troglitazone. Clin. Pharmacokinet. 37:1999;91-104.
36. H.E. Lebovitz, Differentiating Members of the Thiazolidinedione Class: A Focus on Safety, Dissertation, 2002.
37. Day C. Thiazolidinediones: a new class of antidiabetic drugs. Diabe. Med. 16:1999;179-192.