A randomized trial of rosiglitazone therapy in patients with inadequately controlled insulin-treated type 2 diabetes

Philip Raskin, Marc Rendell, Matthew C. Riddle, Jo F. Dole, Martin I. Freed, Julio Rosenstock

Research output: Contribution to journalArticle

288 Scopus citations

Abstract

OBJECTIVE- To determine the efficacy and safety of rosiglitazone (RSG) when added to insulin in the treatment of type 2 diabetic patients who are inadequately controlled on insulin monotherapy. RESEARCH DESIGN AND METHODS- After 8 weeks of insulin standardization and placebo (PBO) run-in, 319 type 2 diabetic patients with mean baseline HbA1c ≥ 7.5% (8.9 ± 1.1 to 9.1 ± 1.3) on twice-daily insulin therapy (total daily dose ≥30 U) were randomized to 26 weeks of additional treatment with RSG (4 or 8 mg daily) or PBO. Insulin dose could be downtitrated only for safety reasons. The primary end point was reduction of HbA1c from baseline. RESULTS- RSG 4 and 8 mg daily significantly improved glycemic control, which was unchanged on PBO. By intent-to-treat analysis, treatment with RSG 8 mg plus insulin resulted in a mean reduction from baseline in HbA1c of 1.2% (P <0.0001), despite a 12% mean reduction of insulin dosage. Over 50% of subjects treated daily with RSG 8 mg plus insulin had a reduction of HbA1c ≥ 1.0%. Neither total:HDL cholesterol nor LDL:HDL cholesterol ratios significantly changed with RSG treatment. Serious adverse events did not differ among groups. CONCLUSIONS- The addition of RSG to insulin treatment results in significant improvement in glycemic control and is generally well tolerated.

Original languageEnglish (US)
Pages (from-to)1226-1232
Number of pages7
JournalDiabetes care
Volume24
Issue number7
DOIs
StatePublished - Jan 1 2001

All Science Journal Classification (ASJC) codes

  • Internal Medicine
  • Endocrinology, Diabetes and Metabolism
  • Advanced and Specialized Nursing

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    Raskin, P., Rendell, M., Riddle, M. C., Dole, J. F., Freed, M. I., & Rosenstock, J. (2001). A randomized trial of rosiglitazone therapy in patients with inadequately controlled insulin-treated type 2 diabetes. Diabetes care, 24(7), 1226-1232. https://doi.org/10.2337/diacare.24.7.1226