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

• Published in: Chinese medical journal Vol. 128; no. 10; pp. 1279 - 1287
• Main Authors: Cai, Xiao-Ling, Chen, Ying-Li, Zhao, Jia-Jun, Shan, Zhong-Yan, Qiu, Ming-Cai, Li, Cheng-Jiang, Gu, Wei, Tian, Hao-Ming, Yang, Hua-Zhang, Xue, Yao-Ming, Yang, Jin-Kui, Hong, Tian-Pei, Ji, Li-Nong
• Format: Journal Article
• Language: English
• Published: China Medknow Publications Pvt Ltd 20.05.2015; Medknow Publications and Media Pvt. Ltd; Lippincott Williams & Wilkins Ovid Technologies; Department of Endocrinology and Metabolism,Peking University People's Hospital,Beijing 100044,China%Department of Endocrinology and Metabolism,Shandong Provincial Hospital,Jinan,Shandong 250021,China%Department of Endocrinology and Metabolism,First Hospital of China Medical University,Shenyang,Liaoning 110001,China%Department of Endocrinology and Metabolism,Tianjin Medical University General Hospital,Tianjin 300070,China%Department of Endocrinology and Metabolism,First Affiliated Hospital of School of Medicine,Zhejiang University,Hangzhou,Zhejiang 310003,China%Department of Endocrinology and Metabolism,Second Affiliated Hospital of School of Medicine,Zhejiang University,Hangzhou,Zhejiang 310009,China; Medknow Publications & Media Pvt Ltd; Wolters Kluwer
• Subjects: 2型糖尿病; Adult; Antidiabetics; Avandamet; Efficacy; Type 2 Diabetes; Blood Glucose - drug effects; C-Reactive Protein - metabolism; Chronic illnesses; Complications and side effects; Diabetes; Diabetes Mellitus, Type 2 - blood; Diabetes Mellitus, Type 2 - drug therapy; Dosage and administration; Drug Combinations; Drug dosages; Drug therapy; Drug Therapy, Combination; Endocrinology; Fasting; Female; Glucose; Heart; Hospitals; Humans; Hypoglycemia; Hypoglycemic Agents - administration & dosage; Hypoglycemic Agents - adverse effects; Hypoglycemic Agents - therapeutic use; Insulin resistance; Male; Metabolism; Metformin; Metformin - administration & dosage; Metformin - adverse effects; Metformin - therapeutic use; Middle Aged; Original; Patients; Thiazoles - administration & dosage; Thiazoles - adverse effects; Thiazoles - therapeutic use; Type 2 diabetes; Vital signs; 二甲双胍; 多中心; 安全性; 对照试验; 患者; 控制试验; 治疗; China; Efficacy; Avandamet; Type 2 Diabetes
• ISSN: 0366-6999; 2542-5641
• DOI: 10.4103/0366-6999.156735

Background：At present,China has listed the compound tablet containing a fixed dose ofrosiglitazone 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 HbA 1 c ≤7% in Avandamet treatment and 70.00% in uptitrated metformin treatment,with significantly difference between groups.The target of HbAlc ≤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 ＆#177; 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 ofglycemic control and was generally well tolerated.Registration number：ChiCTR-TRC-13003776.