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

Methods

Multicentre, double blind, randomised, placebo controlled trial.

多中心、双盲、随机、安慰剂对照试验。

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

2020年6月12日至2023年1月31日，中国大陆的16个中心。

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

328名20至70岁的2型糖尿病患者，体重指数>25，糖尿病病程<6年。

Calorie restriction with dapagliflozin 10 mg/day or placebo.

通过每天10毫克的达格列净或安慰剂进行热量限制。

Primary outcome: incidenceof 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.

主要结果：糖尿病缓解的发生率（定义为糖化血红蛋白<6.5%和空腹血糖<126 mg/dL，在至少2个月内没有使用任何抗糖尿病药物）；次要结果：在12个月内体重、腰围、体脂、血压、血糖稳态参数和血清脂质的变化。

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.

在12个月的研究期间，达格列净组有44%（73/165）的患者和安慰剂组有28%（46/163）的患者实现了糖尿病缓解（风险比为1.56，95%置信区间（CI）为1.17至2.09；P=0.002），达到了预先设定的主要终点。

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.

与安慰剂组相比，达格列净组的体重变化（差异为-1.3（95%置信区间为-1.9至-0.7）kg）和胰岛素抵抗的稳态模型评估（差异为-0.8，-1.1至-0.4）显著更大。

Likewise, body fat, systolic blood pressure, and metabolic risk factors were significantly more improved in the dapagliflozin group than in the placebo group.

同样地，与安慰剂组相比，达格列净组在改善体脂、收缩压和代谢风险因素方面有显著优势。

In addition, no significant differences were seen between the two groups in the occurrence of adverse events.

此外，两组在不良事件发生率上未见显著差异。

Conclusions

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.

dapagliflozin联合常规热量限制方案在超重或肥胖的2型糖尿病患者中实现了比单独热量限制更高的糖尿病缓解率。

trial_registration

ClinicalTrials.gov NCT04004793.

ClinicalTrials.gov NCT04004793。