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Dapagliflozin plus calorie restriction for remission of type 2 diabetes: multicentre, double blind, randomised, placebo controlled trial

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机构： [1]Ministry of Education Key Laboratory of Metabolism and Molecular Medicine, Department of Endocrinology and Metabolism, Zhongshan Hospital, Fudan University, Shanghai, China. [2]Department of Endocrinology, Nanjing First Hospital, Nanjing, China. [3]Department of Endocrinology and Metabolism, Nanfang Hospital, Southern Medical University, Guangzhou, China. [4]Department of Endocrinology and Diabetes, The First Affiliated Hospital of Xiamen University, Xiamen, China. [5]Department of Diabetes and Endocrinology, Affiliated Hospital of Southwest Medical University, Luzhou, China. [6]Department of Endocrinology, The First Affiliated Hospital of Harbin Medical University, Harbin, China. [7]Department of Endocrinology and Metabolism, Affiliated Hospital of Guizhou Medical University, Guizhou, China. [8]Department of Endocrinology, Shanghai East Hospital, Tongji University School of Medicine, Shanghai, China. [9]Department of Endocrinology, Affiliated Drum Tower Hospital, Medical School of Nanjing University, Nanjing, China. [10]Department of Endocrinology, Beijing Chao-Yang Hospital, Capital Medical University, Beijing, China. [11]Department of Endocrinology, Beijing Tongren Hospital, Capital Medical University, Beijing, China. [12]Department of Endocrinology, Peking Union Medical College Hospital, Beijing, China. [13]Department of Endocrinology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China. [14]Department of Endocrinology, Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, Hangzhou, China. [15]Department of Endocrinology and Metabolism, Shanghai Jiaotong University Affiliated Sixth People's Hospital, Shanghai, China. [16]Department of Endocrinology, Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine, Shanghai, China. [17]Department of Biostatistics, Zhongshan Hospital of Fudan University, Center of Evidence-based Medicine, Fudan University, Shanghai, China. [18]Shanghai Key Laboratory of Metabolic Remodeling and Health, Institute of Metabolism and Integrative Biology, Fudan University, Shanghai, China.

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To assess the effect of dapagliflozin plus calorie restriction on remission of type 2 diabetes.Multicentre, double blind, randomised, placebo controlled trial.16 centres in mainland China from 12 June 2020 to 31 January 2023.328 patients with type 2 diabetes aged 20-70 years, with body mass index >25 and diabetes duration of <6 years.Calorie restriction with dapagliflozin 10 mg/day or placebo.Primary outcome: incidence of diabetes remission (defined as glycated haemoglobin <6.5% and fasting plasma glucose <126 mg/dL in the absence of all antidiabetic drugs for at least 2 months); secondary outcomes: changes in body weight, waist circumference, body fat, blood pressure, glucose homoeostasis parameters, and serum lipids over 12 months.Remission of diabetes was achieved in 44% (73/165) of patients in the dapagliflozin group and 28% (46/163) of patients in the placebo group (risk ratio 1.56, 95% confidence interval (CI) 1.17 to 2.09; P=0.002) over 12 months, meeting the predefined primary endpoint. Changes in body weight (difference -1.3 (95% CI -1.9 to -0.7) kg) and homoeostasis model assessment of insulin resistance (difference -0.8, -1.1 to -0.4) were significantly greater in the dapagliflozin group than in the placebo group. Likewise, body fat, systolic blood pressure, and metabolic risk factors were significantly more improved in the dapagliflozin group than in the placebo group. In addition, no significant differences were seen between the two groups in the occurrence of adverse events.The regimen of dapagliflozin plus regular calorie restriction achieved a much higher rate of remission of diabetes compared with calorie restriction alone in overweight or obese patients with type 2 diabetes.ClinicalTrials.gov NCT04004793.© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

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出版当年[2023]版：

Q1 MEDICINE, GENERAL & INTERNAL

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Q1 MEDICINE, GENERAL & INTERNAL

影响因子： 93.7 最新[2023版] 69.9 最新五年平均 93.7 出版当年[2023版] 69.9 出版当年五年平均 107.7 出版前一年[2022版]

第一作者：

第一作者机构： [1]Ministry of Education Key Laboratory of Metabolism and Molecular Medicine, Department of Endocrinology and Metabolism, Zhongshan Hospital, Fudan University, Shanghai, China.

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通讯作者：

通讯机构： [1]Ministry of Education Key Laboratory of Metabolism and Molecular Medicine, Department of Endocrinology and Metabolism, Zhongshan Hospital, Fudan University, Shanghai, China. [18]Shanghai Key Laboratory of Metabolic Remodeling and Health, Institute of Metabolism and Integrative Biology, Fudan University, Shanghai, China.

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