近日，复旦大学李小英教授团队研究了达格列净联合热量限制治疗2型糖尿病对缓解率的影响。相关论文于2025年1月22日发表在《英国医学杂志》上。

为了评估达格列净联合热量限制对2型糖尿病缓解的影响，2020年6月12日至2023年1月31日，研究组在中国的16个中心进行了一项多中心、双盲、随机对照试验。共招募了328名20~70岁、体重指数>25、糖尿病持续时间<6年的2型糖尿病患者。干预措施为达格列净10 mg/天或安慰剂联合热量限制。

主要结局为糖尿病缓解的发生率（定义为糖化血红蛋白<6.5%，空腹血糖<126 mg/dL，且至少2个月未服用所有抗糖尿病药物）；次要结局为12个月内体重、腰围、体脂、血压、葡萄糖稳态参数和血脂的变化。

达格列净组44%（73/165）的患者和安慰剂组28%（46/163）的患者糖尿病缓解（风险比1.56，95%置信区间（CI）1.17至2.09；P=0.002）超过12个月，达到预定义的主要终点。达格列净组的体重变化（差异1.3（95%CI 1.9至0.7）kg）和胰岛素抵抗的稳态模型评估（差异0.8、1.1至0.4）明显大于安慰剂组。同样，与安慰剂组相比，达格列净组的体脂、收缩压和代谢危险因素明显改善。此外，两组不良事件的发生率没有显著差异。

研究结果表明，在超重或肥胖的2型糖尿病患者中，与单独限制热量相比，达格列净联合常规热量限制的方案实现了更高的糖尿病缓解率。

附：英文原文

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

Author: Yuejun Liu, Ying Chen, Jianhua Ma, Jiayang Lin, Changqin Liu, Xuejun Li, Yong Xu, Hongyu Kuang, Lixin Shi, Yaoming Xue, Bo Feng, Dalong Zhu, Guang Wang, Jinkui Yang, Xinhua Xiao, Xuefeng Yu, Jiaqiang Zhou, Yuqian Bao, Qing Su, Minzhi Lyu, Xiaomu Li, Huijie Zhang, Xiaoying Li

Issue&Volume: 2025/01/22

Abstract:

Objective To assess the effect of dapagliflozin plus calorie restriction on remission of type 2 diabetes.

Design Multicentre, double blind, randomised, placebo controlled trial.

Setting 16 centres in mainland China from 12 June 2020 to 31 January 2023.

Participants 328 patients with type 2 diabetes aged 20-70 years, with body mass index >25 and diabetes duration of <6 years.

Interventions Calorie restriction with dapagliflozin 10 mg/day or placebo.

Main outcome measures 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.

Results 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.

Conclusion 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.

DOI: 10.1136/bmj-2024-081820

Source: https://www.bmj.com/content/388/bmj-2024-081820