Dapagliflozin plus calorie restriction for remission of type 2 diabetes: multicentre, double blind, randomised, placebo controlled trial.
Summary
In 328 adults with type 2 diabetes, dapagliflozin plus calorie restriction produced a 44% remission rate at 12 months versus 28% with calorie restriction alone, alongside greater reductions in weight and HOMA-IR and improved metabolic risk factors. Adverse events were similar between groups.
Key Findings
- Diabetes remission at 12 months: 44% with dapagliflozin plus calorie restriction vs 28% with calorie restriction alone (RR 1.56, 95% CI 1.17–2.09).
- Greater reductions in body weight (−1.3 kg vs placebo) and HOMA-IR (difference −0.8) with dapagliflozin.
- Improved body fat, systolic blood pressure, and metabolic risk factors without increased adverse events.
Clinical Implications
Consider SGLT2 inhibitor plus structured calorie restriction for remission-oriented care in overweight/obese patients with early T2D, with close monitoring and individualized dosing.
Why It Matters
This high-quality RCT demonstrates a practical, pharmacologically-augmented dietary strategy to achieve diabetes remission, a central goal in modern diabetes care.
Limitations
- Conducted in China; generalizability to other populations requires validation
- 12-month duration limits assessment of durability of remission
Future Directions
Longer-term and multinational trials assessing durability, cost-effectiveness, micro/macrovascular outcomes, and optimal patient selection for remission protocols.
Study Information
- Study Type
- RCT
- Research Domain
- Treatment/Prevention
- Evidence Level
- I - Randomized, double-blind, placebo-controlled clinical trial
- Study Design
- OTHER