Addition of low-dose rosiglitazone to sulphonylurea therapy improves glycaemic control in Type 2 diabetic patients

Aims This study was designed to test the efficacy and safety of low-dose ro siglitazone, a potent, insulin-sensitizing thiazolidinedione, in combinatio n with sulphonylurea in Type 2 diabetic patients. Methods For the intention-to-treat analysis, 574 patients (59% male, mean a ge 61 years) were available, randomized to receive 26 weeks of twice-daily placebo (n = 192), rosiglitazone 1 mg (n = 199) or rosiglitazone 2 mg (n = 183) in addition to existing sulphonylurea treatment with gliclazide (47.6% of patients), glibenclamide (41.8%) or glipizide (9.4%) (two patients were taking carbutamide or glimepiride). Change in haemoglobin A(1c) (HbA(1c)), fasting plasma glucose (FPG), frustosamine, insulin, C-peptide, albumin, a nd lipids were measured, and safety was evaluated. Results Mean baseline HbA(1c) was 9.2% and FPG was 11.4 mmol/l. Rosiglitazo ne at doses of 1 and 2 mg b.d, plus sulphonylurea produced significant decr eases, compared with sulphonylurea plus placebo, in HbA(1c) (-0.59% and -1. 03%, respectively; both P < 0.0001) and FPG (1.35 mmol/l and 2.44 mmol/l, r espectively; both P < 0.0001). Both HDL-cholesterol and LDL-cholesterol inc reased and potentially beneficial decreases in non-esterified fatty acids a nd gamma glutamyl transpeptidase levels were seen in both rosiglitazone gro ups. The overall incidence of adverse experienccs was similar in all three treatment groups, with no significant cardiac events, hypoglycaemia or hepa totoxicity. Conclusions Overall, the combination of rosiglitazone and a sulphonylurea w as safe, well tolerated and effective in patients with Type 2 diabetes.