A double-blind randomized study comparing the effects of continuing or not continuing rosiglitazone + metformin therapy when starting insulin therapy in people with type 2 diabetes

Diabetic Medicine

Volumn 24, Issue 6, 2007, Pages 618-625

  Home, P D ^a,e   Bailey, C J ^b   Donaldson, J ^c   Chen, H ^d   Stewart, M W ^c  

^a NEWCASTLE UNIVERSITY   (United Kingdom)

^b ASTON UNIVERSITY   (United Kingdom)

^c GLAXOSMITHKLINE   (United Kingdom)

^d GLAXOSMITHKLINE   (United States)

^e NEWCASTLE UNIVERSITY   (United Kingdom)

Author keywords

Insulin; Metformin; Randomized controlled trial; Thiazolidinediones; Type 2 diabetes mellitus

Indexed keywords

HEMOGLOBIN A1C; INSULIN; METFORMIN PLUS ROSIGLITAZONE; PLACEBO;

ABDOMINAL DISCOMFORT; ADULT; ANGINA PECTORIS; ARTICLE; CLINICAL TRIAL; COMBINATION CHEMOTHERAPY; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; DRUG TOLERABILITY; EDEMA; FEMALE; GLYCEMIC CONTROL; HEART FAILURE; HUMAN; HYPOGLYCEMIA; MAJOR CLINICAL STUDY; MALE; MONOTHERAPY; NON INSULIN DEPENDENT DIABETES MELLITUS; PATIENT SATISFACTION; RANDOMIZED CONTROLLED TRIAL; SIDE EFFECT; WEIGHT GAIN;

ADOLESCENT; ADULT; AGED; BLOOD GLUCOSE; DIABETES MELLITUS, TYPE 2; DOUBLE-BLIND METHOD; DRUG COMBINATIONS; DRUG THERAPY, COMBINATION; EUROPE; FEMALE; HUMANS; HYPOGLYCEMIC AGENTS; INSULIN; MALE; METFORMIN; MIDDLE AGED; THIAZOLES; TREATMENT OUTCOME;

EID: 34249337380     PISSN: 07423071     EISSN: 14645491     Source Type: Journal    
DOI: 10.1111/j.1464-5491.2007.02141.x     Document Type: Article

References (31)

1. Klein R, Klein BE, Moss SE, Cruickshanks KJ. The medical management of hyperglycemia over a 10-year period in people with diabetes. Diabetes Care 1996 19:744 750.
2. Yki-Jarvinen H. Combination therapies with insulin in type 2 diabetes. Diabetes Care 2001 24:758 767.
3. Goudswaard AN, Furlong NJ, Rutten GE, Stolk RP, Valk GD. Insulin monotherapy versus combinations of insulin with oral hypoglycaemic agents in patients with type 2 diabetes mellitus. Cochrane Database Syst Rev 2004 CD003418.
4. Yki-Järvinen H, Ryysy L, Nikkilä K, Tulokas T, Vanamo R, Heikkilä M. Comparison of bedtime insulin regimens in patients with type 2 diabetes mellitus. A randomized, controlled trial. Ann Intern Med 1999 130:389 396.
5. Chow CC, Tsang LW, Sorensen JP, Cockram CS. Comparison of insulin with or without continuation of oral hypoglycemic agents in the treatment of secondary failure in NIDDM patients. Diabetes Care 1995 18:307 314.
6. Douek IF, Allen SE, Ewings P, Gale EA, Bingley PJ. Continuing metformin when starting insulin in patients with Type 2 diabetes: a double-blind randomized placebo-controlled trial. Diabet Med 2005 22:634 640.
7. Canadian Diabetes Association. Canadian Diabetes Association 2003 clinical practice guidelines for the prevention and management of diabetes in Canada. Can J Diabetes 2003 27 (Suppl. 2):S1 S152.
8. International Diabetes Federation Clinical Guidelines Taskforce. Global Guideline for Type Diabetes. 2005. Available from: http://www.idf.org/webdata/ docs/IDF%20GGT2D.pdf (accessed 4 September 2006).
9. Einhorn D, Rendell M, Rosenzweig J, Egan JW, Mathisen AL, Schneider RL. Pioglitazone hydrochloride in combination with metformin in the treatment of type 2 diabetes mellitus: a randomized, placebo-controlled study. The Pioglitazone 027 Study Group. Clin Ther 2000 22:1395 1409.
10. 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 2000 283:1695 1702.
11. Jones TA, Sautter M, Van Gaal LF, Jones NP. Addition of rosiglitazone to metformin is most effective in obese, insulin-resistant patients with type 2 diabetes. Diabetes Obes Metab 2003 5:163 170.
12. Bailey CJ, Bagdonas A, Rubes J, McMorn SO, Donaldson J, Biswas N et al. Rosiglitazone/metformin fixed-dose combination compared with uptitrated metformin alone in type 2 diabetes: a 24-week, randomized, double-blind, parallel-group study. Clin Ther 2005 27:1548 1561.
13. Bailey CJ, Day C. Avandamet: combined metformin-rosiglitazone treatment for insulin resistance in type 2 diabetes. Int J Clin Pract 2004 58:867 876.
14. 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 2001 44:2210 2219.
15. Stumvoll M, Nurjhan N, Perriello G, Dailey G, Gerich JE. Metabolic effects of metformin in non-insulin-dependent diabetes mellitus. N Engl J Med 1995 333:550 554.
16. Bailey CJ. Treating insulin resistance in type 2 diabetes with metformin and thiazolidinediones. Diabetes Obes Metab 2005 7:675 691.
17. 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.
18. Rosak C, Petzoldt R, Wolf R, Reblin T, Dehmel B, Seidel D. Rosiglitazone plus metformin is effective and well tolerated in clinical practice: results from large observational studies in people with type 2 diabetes. Int J Clin Pract 2005 59:1131 1136.
19. Raskin P, Rendell M, Riddle MC, Dole JF, Freed MI, Rosenstock J. A randomized trial of rosiglitazone therapy in patients with inadequately controlled insulin-treated type 2 diabetes. Diabetes Care 2001 24:1226 1232.
20. Nesto RW, Bell D, Bonow RO, Fonseca V, Grundy SM, Horton ES et al. Thiazolidinedione use, fluid retention, and congestive heart failure: a consensus statement from the American Heart Association and American Diabetes Association. Diabetes Care 2004 27:256 263.
21. World Health Organization. Definition, Diagnosis and Classification of Diabetes Mellitus and its Complications. Part I. Diagnosis and Classification of Diabetes Mellitus. Geneva:WHO Department of Noncommunicable Disease Surveillance, 1999.
22. Bradley C. Diabetes Treatment Satisfaction Questionnaire (DTSQ). In:Bradley, C, ed. Handbook of Psychology and Diabetes: A Guide to Psychological Measurement in Diabetes Research and Management. Langhorne:Harwood Academic Publishers, 1994.
23. Rosenstock J, Cappelleri JC, Bolinder B, Gerber RA. Patient satisfaction and glycemic control after 1 year with inhaled insulin (Exubera) in patients with type 1 or type 2 diabetes. Diabetes Care 2004 27:1318 1323.
24. UK Prospective Diabetes Study (UKPDS) Group. United Kingdom Prospective Diabetes Study 24: a 6-year, randomized, controlled trial comparing sulfonylurea, insulin, and metformin therapy in patients with newly diagnosed type 2 diabetes that could not be controlled with diet therapy. Ann Intern Med 1998 128:165 175.
25. Despres JP, Lamarche B, Mauriege P, Cantin B, Dagenais GR, Moorjani S et al. Hyperinsulinemia as an independent risk factor for ischemic heart disease. N Engl J Med 1996 334:952 957.
26. Riddle MC, Rosenstock J, Gerich J. The treat-to-target trial: randomized addition of glargine or human NPH insulin to oral therapy of type 2 diabetic patients. Diabetes Care 2003 26:3080 3086.
27. Yki-Järvinen H, Hanninen J, Hulme S. Treat To Target simply - the LANMET study. Diabetes 2004 53 (Suppl. 2):A519.
28. Raskin P, Allen E, Hollander P, Lewin A, Gabbay RA, Hu P et al. Initiating insulin therapy in type 2 diabetes: a comparison of biphasic and basal insulin analogs. Diabetes Care 2005 28:260 265.
29. European Diabetes Policy Group. A desktop guide to Type 2 diabetes. Diabet Med 1999 16:716 730.
30. Lebovitz HE, Austin MM, Blonde L, Davidson JA, Del Prato S, Gavin JR, III. et al. ACE/AACE consensus conference on the implementation of out patient management of diabetes mellitus: consensus conference reccommendations. Endocr Pract 2006 12 (Suppl. 1):6 12.
31. Janka HU, Plewe G, Riddle MC, Kliebe-Frisch C, Schweitzer MA, Yki-Jarvinen H. Comparison of basal insulin added to oral agents versus twice-daily premixed insulin as initial insulin therapy for type 2 diabetes. Diabetes Care 2005 28:254 259.