Barry J Goldstein1, Alexander R Cobitz, Linda M Hand, Hongzi Chen. 1. Division of Endocrinology, Diabetes and Metabolic Diseases, Jefferson Medical College, Thomas Jefferson University, Philadelphia, PA 19107-6799, USA. Barry.Goldstein@mail.tju.edu
Abstract
OBJECTIVE: To compare the metabolic effects of rosiglitazone, an antidiabetic agent of the thiazolidinedione class, in patients with type 2 diabetes with fair to moderate glycaemic control (glycosylated haemoglobin (HbA(lc)) < 9%) and poor glycaemic control (HbA(lc) > or = 9%). RESEARCH DESIGN AND METHODS: Data were pooled from two 26-week, randomised, placebo-controlled, double-blind studies of rosiglitazone (4 and 8 mg/day). RESULTS: After 26 weeks of treatment, HbA(lc) was significantly reduced (p < 0.05) compared with baseline and placebo in patients taking rosiglitazone 8 mg/day for both HbA(lc) stratifications, with greater reductions in patients with baseline HbA(lc) > or = 9%. After 26 weeks of treatment, reductions in fasting plasma glucose (FPG) were significant (p < 0.05) compared with baseline and placebo in both rosiglitazone treatment groups for both HbA(lc) stratifications, with greater reductions in the group with poor glycaemic control. Rosiglitazone significantly improved insulin sensitivity (p < 0.05) compared with baseline in patients with baseline HbA(lc) < 9%. Rosiglitazone significantly improved beta-cell function (p < 0.05) compared with baseline with more improvement in the group with baseline HbA(lc) > or = 9%. These improvements were statistically significant compared with placebo, regardless of HbA(lc) stratification. CONCLUSION:Rosiglitazone significantly improved HbA(lc) and FPG levels in patients with type 2 diabetes, with the greatest improvements observed in patients with baseline HbA(lc) levels > or =9%.
RCT Entities:
OBJECTIVE: To compare the metabolic effects of rosiglitazone, an antidiabetic agent of the thiazolidinedione class, in patients with type 2 diabetes with fair to moderate glycaemic control (glycosylated haemoglobin (HbA(lc)) < 9%) and poor glycaemic control (HbA(lc) > or = 9%). RESEARCH DESIGN AND METHODS: Data were pooled from two 26-week, randomised, placebo-controlled, double-blind studies of rosiglitazone (4 and 8 mg/day). RESULTS: After 26 weeks of treatment, HbA(lc) was significantly reduced (p < 0.05) compared with baseline and placebo in patients taking rosiglitazone 8 mg/day for both HbA(lc) stratifications, with greater reductions in patients with baseline HbA(lc) > or = 9%. After 26 weeks of treatment, reductions in fasting plasma glucose (FPG) were significant (p < 0.05) compared with baseline and placebo in both rosiglitazone treatment groups for both HbA(lc) stratifications, with greater reductions in the group with poor glycaemic control. Rosiglitazone significantly improved insulin sensitivity (p < 0.05) compared with baseline in patients with baseline HbA(lc) < 9%. Rosiglitazone significantly improved beta-cell function (p < 0.05) compared with baseline with more improvement in the group with baseline HbA(lc) > or = 9%. These improvements were statistically significant compared with placebo, regardless of HbA(lc) stratification. CONCLUSION:Rosiglitazone significantly improved HbA(lc) and FPG levels in patients with type 2 diabetes, with the greatest improvements observed in patients with baseline HbA(lc) levels > or =9%.