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Liraglutide provides similar glycaemic control as glimepiride (both in combination with metformin) and reduces body weight and systolic blood pressure in Asian population with type 2 diabetes from China, South Korea and India: a 16-week, randomized, double-blind, active control trial

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单位: [1]China Japan Friendship Hosp, Dept Endocrinol, Beijing 100029, Peoples R China [2]Wuhan Union Hosp, Dept Endocrinol, Wuhan, Hubei, Peoples R China [3]4th Mil Med Univ, Xijing Hosp, Dept Endocrinol, Xian, Shaanxi, Peoples R China [4]Harbin Med Univ, Affiliated Hosp 1, Dept Endocrinol, Haebin, Peoples R China [5]Nanjing First Hosp, Dept Endocrinol, Nanjing, Jiangsu, Peoples R China [6]All India Inst Med Sci, Dept Endocrinol & Metab, New Delhi, India [7]Manipal Hosp, Dept Endocrinol & Diabet, Bangalore, Karnataka, India [8]Diabet Care & Res Ctr, Patna, Bihar, India [9]Sungkyunkwan Univ, Sch Med, Samsung Med Ctr, Dept Med,Div Endocrinol & Metab, Seoul, South Korea [10]Catholic Univ Korea, Kangnam St Marys Hosp, Dept Endocrinol & Metab, Seoul, South Korea [11]Novo Nordisk China Pharmaceut Co Ltd, Int Operat Clin Dev Ctr, Beijing, Peoples R China [12]Novo Nordisk AS, Med & Sci GLP 1, Soborg, Denmark
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关键词: Asia glimepiride GLP-1 analogue incretin therapy liraglutide randomized trial type 2 diabetes

摘要:
Aim: To assess and compare the efficacy and safety of liraglutide with those of glimepiride, both in combination with metformin for the treatment of type 2 diabetes in Asian population from China, South Korea and India. Methods: A 16-week, randomized, double-blind, double-dummy, four-arm, active control trial was carried out. In total, 929 subjects with type 2 diabetes with a mean (+/- s.d.) age of 53.3 +/- 9.5 years, HbA(1c) of 8.6 +/- 1.0% and body weight of 68.1 +/- 11.7 kg were randomized (liraglutide 0.6, 1.2 or 1.8 mg once daily or glimepiride 4 mg once daily all in combination with metformin: 1 : 1 : 1 : 1). One subject withdrew immediately after randomization and before exposure. Results: HbA(1c) was significantly reduced in all groups compared with baseline. Treatment with liraglutide 1.2 and 1.8 mg was non-inferior to glimepiride (mean HbA(1c) reduction: 1.36% points, 1.45% points and 1.39% points, respectively). No significant difference was shown in the percentage of subjects reaching American Diabetes Association HbA(1c) target <7% or American Association of Clinical Endocrinologists target <= 6.5% between liraglutide 1.2 and 1.8 mg and glimepiride. Liraglutide was associated with a 1.8-2.4 kg mean weight reduction, compared with a 0.1 kg mean weight gain with glimepiride. Liraglutide led to a significantly greater reduction in systolic blood pressure (SBP) compared with glimepiride. Two subjects in the glimepiride group reported major hypoglycaemia while none in the liraglutide groups. Liraglutide was associated with about 10-fold lower incidence of minor hypoglycaemia than glimepiride. Gastrointestinal disorders were the most common adverse events (AEs) for liraglutide, but were transient and resulted in few withdrawals. Conclusions: In Asian subjects with type 2 diabetes, once-daily liraglutide led to improvement in glycaemic control similar to that with glimepiride but with less frequent major and minor hypoglycaemia. Liraglutide also induced a significant weight loss and reduced SBP and was generally well tolerated. The most frequently reported AE was transient nausea. The effect of liraglutide in this Asian population is comparable to the effects seen in Caucasian, African American and Hispanic populations in global liraglutide phase 3 trials.

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出版当年[2010]版:
大类 | 2 区 医学
小类 | 3 区 内分泌学与代谢
最新[2025]版:
大类 | 2 区 医学
小类 | 2 区 内分泌学与代谢
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出版当年[2009]版:
Q2 ENDOCRINOLOGY & METABOLISM
最新[2023]版:
Q1 ENDOCRINOLOGY & METABOLISM

影响因子: 最新[2023版] 最新五年平均[2021-2025] 出版当年[2009版] 出版当年五年平均[2005-2009] 出版前一年[2008版] 出版后一年[2010版]

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第一作者单位: [1]China Japan Friendship Hosp, Dept Endocrinol, Beijing 100029, Peoples R China [*1]China Japan Friendship Hosp, Dept Endocrinol, 2 Ying Hua Dong Lu, Beijing 100029, Peoples R China
通讯作者:
通讯机构: [1]China Japan Friendship Hosp, Dept Endocrinol, Beijing 100029, Peoples R China [*1]China Japan Friendship Hosp, Dept Endocrinol, 2 Ying Hua Dong Lu, Beijing 100029, Peoples R China
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