title: Efficacy and safety of avandamet or uptitrated metformin treatment in patients with type 2 diabetes inadequately controlled with metformin alone: a multicenter, randomized, controlled trial.
abstract: BACKGROUND
  At present, China has listed the compound tablet containing a fixed dose of rosiglitazone and metformin, Avandamet, which may improve patient compliance. The aim of this study was to evaluate the efficacy and safety of Avandamet or uptitrated metformin treatment in patients with type 2 diabetes inadequately controlled with metformin alone.
  
  
  METHODS
  This study was a 48-week, multicenter, randomized, open-labeled, active-controlled trial. Patients with inadequate glycaemic control (glycated hemoglobin [HbA1c] 7.5-9.5%) receiving a stable dose of metformin (≥1500 mg) were recruited from 21 centers in China (from 19 November, 2009 to 15 March, 2011). The primary objective was to compare the proportion of patients who reached the target of HbA1c ≤7% between Avandamet and metformin treatment.
  
  
  RESULTS
  At week 48, 83.33% of patients reached the target of HbA1c ≤7% in Avandamet treatment and 70.00% in uptitrated metformin treatment, with significantly difference between groups. The target of HbA1c ≤6.5% was reached in 66.03% of patients in Avandamet treatment and 46.88% in uptitrated metformin treatment. The target of fasting plasma glucose (FPG) ≤6.1 mmol/L was reached in 26.97% of patients in Avandamet treatment and 19.33% in uptitrated metformin treatment. The target of FPG ≤7.0 mmol/L was reached in 63.16% of patients in Avandamet treatment and 43.33% in uptitrated metformin treatment. Fasting insulin decreased 3.24 ± 0.98 μU/ml from baseline in Avandamet treatment and 0.72 ± 1.10 μU/ml in uptitrated metformin treatment. Overall adverse event (AE) rates and serious AE rates were similar between groups. Hypoglycaemia occurred rarely in both groups.
  
  
  CONCLUSIONS
  Compared with uptitrated metformin, Avandamet treatment provided significant improvements in key parameters of glycemic control and was generally well tolerated.
  
  
  BACKGROUND
  ChiCTR-TRC-13003776.
authors.forename: Xiao-Ling
authors.initials: XL
authors.lastname: Cai
authors.forename: Ying-Li
authors.initials: YL
authors.lastname: Chen
authors.forename: Jia-Jun
authors.initials: JJ
authors.lastname: Zhao
authors.forename: Zhong-Yan
authors.initials: ZY
authors.lastname: Shan
authors.forename: Ming-Cai
authors.initials: MC
authors.lastname: Qiu
authors.forename: Cheng-Jiang
authors.initials: CJ
authors.lastname: Li
authors.forename: Wei
authors.initials: W
authors.lastname: Gu
authors.forename: Hao-Ming
authors.initials: HM
authors.lastname: Tian
authors.forename: Hua-Zhang
authors.initials: HZ
authors.lastname: Yang
authors.forename: Yao-Ming
authors.initials: YM
authors.lastname: Xue
authors.forename: Jin-Kui
authors.initials: JK
authors.lastname: Yang
authors.forename: Tian-Pei
authors.initials: TP
authors.lastname: Hong
authors.affiliation: Department of Endocrinology and Metabolism, Peking University People's Hospital, Beijing 100044, China.
authors.forename: Li-Nong
authors.initials: LN
authors.lastname: Ji
mesh_terms: D000328:Adult; D001786:Blood Glucose / Q000187:drug effects; D002097:C-Reactive Protein / Q000378:metabolism; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000188:drug therapy*; D004338:Drug Combinations; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D007004:Hypoglycemic Agents / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use*; D008297:Male; D008687:Metformin / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use*; D008875:Middle Aged; D013844:Thiazoles / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use*
chemical_list: D001786:Blood Glucose; D004338:Drug Combinations; D007004:Hypoglycemic Agents; D013844:Thiazoles; C471074:rosiglitazone-metformin combination; D002097:C-Reactive Protein; D008687:Metformin