Dapagliflozin plus calorie restriction for remission of type 2 diabetes: multicentre, double blind, randomised, placebo controlled trial
Primary result · Diabetes remission (HbA1c <6.5% and FPG <126 mg/dL without antidiabetic drugs ≥2 months)Result — go to the resultRR for diabetes remission 1.56 95% CI 1.17–2.09Authors' 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.
Study context
- Population
- Patients with T2D aged 20–70 years, BMI >25, diabetes duration <6 years; 16 centres in mainland China, 2020–2023
- Participants
- 328 patients
- Comparison
- Dapagliflozin 10 mg/day plus calorie restriction vs placebo plus calorie restriction
- Dapagliflozinn = 165
- Placebon = 163reference
- Primary endpoint
- Incidence of diabetes remission (HbA1c <6.5% and FPG <126 mg/dL without any antidiabetic drugs for at least 2 months)
- Follow-up
- 12 months
Methodological detailsmulticentre, double-blind, placebo-controlled
- Multicentre
- Double-blind
- Placebo-controlled
Primary result
As reported in the abstract
Diabetes remission (HbA1c <6.5% and FPG <126 mg/dL without antidiabetic drugs ≥2 months)
RR for diabetes remission
1.56
95% CI 1.17–2.09
P = 0.002
Events by treatment group
Dapagliflozinvs Placebo
RR for diabetes remission 1.56 (95% CI 1.17–2.09); P = 0.002
Secondary outcomes
| Outcome | Difference (kg) (95% CI) | |
|---|---|---|
| Change in body weight · 12 monthsSignificantly greater change with dapagliflozin | −1.3 (−1.9 to −0.7) | |
| −2−101Difference, kg (linear scale) |
| Outcome | Difference (CI) | |
|---|---|---|
| Change in HOMA-IR · 12 monthsSignificantly greater change with dapagliflozin | −0.8 (−1.1 to −0.4) | |
| −1.5−1−0.500.5Difference (linear scale) |
Body fat, systolic BP and metabolic risk factors
- Body fat, systolic BP and metabolic risk factors significantly more improved with dapagliflozin vs placebo
Safety
- No significant differences between the two groups in occurrence of adverse events
Original publication
Dapagliflozin plus calorie restriction for remission of type 2 diabetes: multicentre, double blind, randomised, placebo controlled trial. BMJ. Published 22 January 2025. doi:10.
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