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

IMR OpenIR

	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
其他题名	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
	Cai XiaoLing 1; Chen YingLi 1; Zhao JiaJun 2; Shan ZhongYan 3; Qiu MingCai 4; Li ChengJiang 5; Gu Wei 5; Tian HaoMing 6; Yang HuaZhang 7; Xue YaoMing 7; Yang JinKui 8; Hong TianPei 1; Ji LiNong 1
	2015
发表期刊	Chinese Medical Journal
ISSN	0366-6999
卷号	128 期号:10 页码:1279-1287
摘要	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. Registration number: ChiCTR-TRC-13003776.
其他摘要	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 Conclusions: Compared with uptitrated metformin, Avandamet treatment provided significant improvements in key parameters of glycemic control and was generally well tolerated. Registration number: ChiCTR-TRC-13003776.
关键词	Avandamet Medicine R Efficacy Type 2 Diabetes
收录类别	CSCD
语种	英语
资助项目	[GlaxoSmithKline]
CSCD记录号	CSCD:5419638
引用统计	被引频次：2[CSCD] [CSCD记录]
文献类型	期刊论文
条目标识符	http://ir.imr.ac.cn/handle/321006/153604
专题	中国科学院金属研究所
作者单位	1.北京大学 2.Shandong Prov Hosp, Department Endocrinol & Metab, Jinan 250021, Shandong, Peoples R China 3.中国科学院金属研究所 4.Tianjin Med University, Gen Hosp, Dept Endocrinol & Metab, Tianjin 300070, Peoples R China 5.浙江大学 6.四川大学 7.中国科学院广州地球化学研究所 8.Beijing Tongren Hosp, Department Endocrinol & Metab, Beijing 100730, Peoples R China
推荐引用方式 GB/T 7714	Cai XiaoLing,Chen YingLi,Zhao JiaJun,et al. 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[J]. Chinese Medical Journal,2015,128(10):1279-1287.
APA	Cai XiaoLing.,Chen YingLi.,Zhao JiaJun.,Shan ZhongYan.,Qiu MingCai.,...&Ji LiNong.(2015).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.Chinese Medical Journal,128(10),1279-1287.
MLA	Cai XiaoLing,et al."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".Chinese Medical Journal 128.10(2015):1279-1287.