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 29.1±35.38 mg/dL (P<0.0001). Significant alterations from baseline to week 8 in either one or both treatment groups were also noted for the following parameters: 1,5-anhydroglucitol, glycoalbumin, triglycerides, high-density lipoprotein cholesterol, and free fatty acid levels. Five patients in Group A (16.1%) had five treatment-related adverse events, and 10 patients in Group B (32.3%) had 13 such events; all events were mild.
Conclusions:
Pioglitazone/glimepiride as a FDC (30 mg/3 mg and 15 mg/1 mg once daily) significantly improved glycemic control and lipid profiles and was well tolerated in Japanese patients with type 2 diabetes.
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