Rosiglitazone taken once daily provides effective glycaemic control in patients with Type 2 diabetes mellitus

Aims To evaluate the clinical efficacy and safety of rosiglitazone as a onc e daily treatment for Type 2 diabetes mellitus (DM). Methods Three hundred and sixty-nine patients with Type 2 DM (mean age 63 y ears; mean body mass index (BMI) 29.4 kg/m(2)) were enrolled in a double-bl ind, parallel group, placebo-controlled, dose-ranging study. Patients were randomly assigned to receive placebo or rosiglitazone at doses of 4, 8, or 12 mg daily for 8 weeks. Results At 8 weeks, fasting plasma glucose (FPG) decreased significantly in the rosiglitazone 4 mg, 8 mg, and 12 mg groups (-0.9, -2.0 and -1.7 mmol/l ; P = 0.0003, < 0.0001, and < 0.0001, respectively) compared with placebo ( +0.4 mmol/l). The improvements in FPG were dose ordered for 4 and 8 mg/day. The 12 mg/day dose produced no additional improvement. There were small de creases in haemoglobin and haematocrit in the rosiglitazone treatment group s. The overall incidence of adverse experiences was similar in all treatmen t groups, including placebo with no evidence of hypoglycaemia or hepatotoxi city. Conclusions Rosiglitazone improves glycaemic control when given once daily to treat Type 2 diabetes mellitus and is well tolerated at doses up to and including 12 mg.