title: 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.
  
  
  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.affiliation: Pharmacovigilance, Takeda Pharmaceutical Company Ltd., Osaka, Japan. shinzo.hiroi@takeda.com
authors.forename: Shinzo
authors.initials: S
authors.lastname: Hiroi
authors.forename: Kenkichi
authors.initials: K
authors.lastname: Sugiura
authors.forename: Kumi
authors.initials: K
authors.lastname: Matsuno
authors.forename: Masashi
authors.initials: M
authors.lastname: Hirayama
authors.forename: Kenji
authors.initials: K
authors.lastname: Kuriyama
authors.forename: Kohei
authors.initials: K
authors.lastname: Kaku
authors.forename: Koji
authors.initials: K
authors.lastname: Kawakami
mesh_terms: D044466:Asian People; D001786:Blood Glucose / Q000187:drug effects / Q000378:metabolism*; D015992:Body Mass Index; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000188:drug therapy*; D004032:Diet; D004305:Dose-Response Relationship, Drug; D004338:Drug Combinations; D015444:Exercise; D005260:Female; D006442:Glycated Hemoglobin / Q000378:metabolism; D006801:Humans; D007004:Hypoglycemic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D008055:Lipids / Q000097:blood*; D008297:Male; D008875:Middle Aged; D000077205:Pioglitazone; D013453:Sulfonylurea Compounds / Q000008:administration & dosage* / Q000009:adverse effects; D045162:Thiazolidinediones / Q000008:administration & dosage* / Q000009:adverse effects; D016896:Treatment Outcome
chemical_list: D001786:Blood Glucose; D004338:Drug Combinations; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D008055:Lipids; D000077205:Pioglitazone; D013453:Sulfonylurea Compounds; D045162:Thiazolidinediones; C517652:hemoglobin A1c protein, human; C057619:glimepiride