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 (HbA(1c)) level of ≥7.4% and <10.4% halfway through a 4-week run-in period while being treated withglimepiride 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 HbA(1c) 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.
RCT Entities:
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 (HbA(1c)) 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 HbA(1c) 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.
Authors: Sanjay Kalra; A H Aamir; Abbas Raza; A K Das; A K Azad Khan; Dina Shrestha; Md Faisal Qureshi; Md Faruque Pathan; Fatema Jawad; Jyoti Bhattarai; Nikhil Tandon; Noel Somasundaram; Prasad Katulanda; Rakesh Sahay; Sanjib Dhungel; Sarita Bajaj; Subhankar Chowdhury; Sujoy Ghosh; S V Madhu; Tofail Ahmed; Uditha Bulughapitiya Journal: Indian J Endocrinol Metab Date: 2015 Sep-Oct
Authors: Elizabeth Selvin; Dan Wang; John William McEvoy; Stephen P Juraschek; Mariana Lazo; Pavel Hamet; Mark E Cooper; Michel Marre; Bryan Williams; Stephen Harrap; John Chalmers; Mark Woodward Journal: Diabetes Obes Metab Date: 2019-05-29 Impact factor: 6.577