An international study of the effects of rosiglitazone plus sulphonylurea in patients with type 2 diabetes.

This was an open-label, randomised 26-week study to determine the effects of adding 4 mg rosiglitazone (Avandia) daily to existing sulphonylurea (SU) therapy in patients with type 2 diabetes from India, Brazil, The Philippines, Thailand, Argentina and Tunisia. Of the 348 patients, 175 received 2 mg rosiglitazone twice daily plus SU (RSG+SU) and 173 received SU alone (at their normal dose). The RSG+SU group showed a significant reduction in HbA1c (mean HbA1c 9.05% at baseline, 7.92% at 26 weeks, mean change -1.13 (95% Cl -1.37, -0.89)). Mean HbA1c essentially remained unchanged in the control group (8.9 to 9.0%). The RSG+SU group showed a significant decrease in fasting plasma glucose concentration (FPG) (mean FPG 198.7 mg/dl at baseline, 160.3 mg/dl at 26 weeks, mean change -38.4 (95% Cl -47.1, -29.7)) while the controls showed a non-significant increase from 194 to 200 mg/dl. Significantly more patients in the RSG+SU group achieved FPG < 140 mg/dl, > or = 0.7% decrease in HbA1c, and > or = 30 mg/dl decrease in FPG between baseline and week 26 than the controls (p = 0.0001 in each case). Adverse events were similar in both groups; more patients in the RSG+SU group reported hypoglycaemia, but most cases were mild. This study shows that adding rosiglitazone to existing SU treatment improves glycaemic control and is well-tolerated in patients with type 2 diabetes from a wide range of non-Western countries.