A Multicenter, Phase III Evaluation of the Efficacy and Safety of a New Fixed-Dose Pioglitazone/Glimepiride Combination Tablet in Japanese Patients with Type 2 Diabetes

Abstract Background: This study aimed to determine the efficacy and safety of pioglitazone/glimepiride as a fixed-dose combination (FDC) in Japanese patients with type 2 diabetes. Subjects and Methods: In this multicenter, Phase III, open-label evaluation, eligible patients had to have a glycosylated hemoglobin (HbA1c) level of ≥7.4% and <10.4% halfway through a 4-week run-in period while being treated with glimepiride 1 or 3 mg once daily plus diet and exercise. At baseline, patients were assigned to 8 weeks of treatment with pioglitazone/glimepiride (15 mg/1 mg) FDC once daily (Group A; n=31) or pioglitazone/glimepiride (30 mg/3 mg) FDC once daily (Group B; n=31) according to their glimepiride dose during run-in. Results: Pioglitazone/glimepiride significantly reduced the mean HbA1c level from baseline (primary end point) by 0.59±0.556% in Group A (P<0.0001) and by 0.55±0.637% in Group B (P<0.0001). Corresponding reductions in the mean fasting blood glucose level were 12.5±21.67 mg/dL (P=0.0032) and 29....