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学科主题: 临床医学
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
作者: Cai, Xiao-Ling1; Chen, Ying-Li1; Zhao, Jia-Jun2; Shan, Zhong-Yan3; Qiu, Ming-Cai4; Li, Cheng-Jiang5; Gu, Wei6; Tian, Hao-Ming7; Yang, Hua-Zhang8; Xue, Yao-Ming9; Yang, Jin-Kui10; Hong, Tian-Pei11; Ji, Li-Nong1
关键词: Avandamet ; Efficacy ; Type 2 Diabetes
刊名: CHINESE MEDICAL JOURNAL
发表日期: 2015-05-20
DOI: 10.4103/0366-6999.156735
卷: 128, 期:10, 页:1279-1287
收录类别: SCI
文章类型: Article
WOS标题词: Science & Technology
类目[WOS]: Medicine, General & Internal
研究领域[WOS]: General & Internal Medicine
关键词[WOS]: DOSE COMBINATION THERAPY ; BETA-CELL FUNCTION ; ASIANS SIMILARITIES ; ROSIGLITAZONE ; POPULATIONS ; ADOPT
英文摘要:

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 mu U/ml from baseline in Avandamet treatment and 0.72 +/- 1.10 mu U/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.

语种: 英语
项目资助者: GlaxoSmithKline
WOS记录号: WOS:000356466900001
Citation statistics:
内容类型: 期刊论文
URI标识: http://ir.bjmu.edu.cn/handle/400002259/54784
Appears in Collections:北京大学第二临床医学院_期刊论文

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作者单位: 1.Peking Univ, Peoples Hosp, Dept Endocrinol & Metab, Beijing 100044, Peoples R China
2.Shandong Prov Hosp, Dept Endocrinol & Metab, Jinan 250021, Shandong, Peoples R China
3.China Med Univ, Hosp 1, Dept Endocrinol & Metab, Shenyang 110001, Liaoning, Peoples R China
4.Tianjin Med Univ, Gen Hosp, Dept Endocrinol & Metab, Tianjin 300070, Peoples R China
5.Zhejiang Univ, Sch Med, Affiliated Hosp 1, Dept Endocrinol & Metab, Hangzhou 310003, Zhejiang, Peoples R China
6.Zhejiang Univ, Sch Med, Affiliated Hosp 2, Dept Endocrinol & Metab, Hangzhou 310009, Zhejiang, Peoples R China
7.Sichuan Univ, West China Hosp, Dept Endocrinol & Metab, Chengdu 610041, Sichuan, Peoples R China
8.Guangdong Gen Hosp, Dept Endocrinol & Metab, Guangzhou 510080, Guangdong, Peoples R China
9.South Hosp, Dept Endocrinol & Metab, Guangzhou 510515, Guangdong, Peoples R China
10.Beijing Tongren Hosp, Dept Endocrinol & Metab, Beijing 100730, Peoples R China
11.Peking Univ, Hosp 3, Dept Endocrinol & Metab, Beijing 100191, Peoples R China

Recommended Citation:
Cai, Xiao-Ling,Chen, Ying-Li,Zhao, Jia-Jun,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.
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