SUMMARY
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 (HbA1c) < 9%) and poor glycaemic control (HbA1c > 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, HbA1c was significantly reduced (p < 0.05) compared with baseline and placebo in patients taking rosiglitazone 8mg/day for both HbA1c stratifications, with greater reductions in patients with baseline HbA1c >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 HbA1c 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 HbA1c <9%. Rosiglitazone significantly improved beta-cell function (p < 0.05) compared with baseline with more improvement in the group with baseline HbA1c >9%. These improvements were statistically significant compared with placebo, regardless of HbA1c stratification.
Conclusion: Rosiglitazone significantly improved HbA1c and FPG levels in patients with type 2 diabetes, with the greatest improvements observed in patients with baseline HbA1c levels >9%.