A study to assess the effect of dapagliflozin plus calorie restriction on remission of type 2 diabetes (1):
Study Design:
- 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
Intervention:
- calorie restriction with dapagliflozin 10 mg/day or placebo
Study 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 month
Study 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
- mean body weight reduction was 6%
- 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.
Notes:
- in the DiRECT trial, participants who had had diabetes for up to six years underwent an intensive dietary intervention
- diabetes remission (defined as glycated haemoglobin (HbA1c) <6.5% after at least two months off all antidiabetic drugs) was achieved in 46% of the intervention group, with a mean body weight reduction of 10%
Reference:
- Liu Y, Chen Y, Ma J, Lin J, Liu C, Li X et al. Dapagliflozin plus calorie restriction for remission of type 2 diabetes: multicentre, double blind, randomised, placebo controlled trialBMJ 2025; 388 :e081820
- Lean ME et al. Primary care-led weight management for remission of type 2 diabetes (DiRECT): an open-label, cluster-randomised trial. Lancet. 2018 Feb 10;391(10120):541-551.