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Randomized Controlled Trial Clinical Trial
Are the metabolic effects of rosiglitazone influenced by baseline glycaemic control?
- Barry J Goldstein, Alexander R Cobitz, Linda M Hand, and Hongzi Chen.
- Division of Endocrinology, Diabetes and Metabolic Diseases, Jefferson Medical College, Thomas Jefferson University, Philadelphia, PA 19107-6799, USA. Barry.Goldstein@mail.tju.edu
- Curr Med Res Opin. 2003 Jan 1; 19 (3): 192199192-9.
ObjectiveTo 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 MethodsData were pooled from two 26-week, randomised, placebo-controlled, double-blind studies of rosiglitazone (4 and 8 mg/day).ResultsAfter 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.ConclusionRosiglitazone 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%.
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