Remission of Type 2 Diabetes With Dapagliflozin (READ Trial)

Phase 4 Completed 328 enrolled Shanghai Zhongshan Hospital

RandomizedParallel-groupTriple-blindTreatment

Summary

This is a multicenter, randomized, double-blind, placebo-controlled study to assess the effect of dapagliflozin add-on intensive lifestyle intervention for remission of type 2 diabetes in obese patients with Type 2 Diabetes Mellitus. The study consists of a 12-months treatment period (in which they will receive either Dapagliflozin plus intensive lifestyle intervention or placebo plus intensive lifestyle intervention in addition to the background therapy), and a 2-month follow-up period after treatment period.

Timeline

Start: 2020-06-12
Primary completion: 2023-01-31
Completion: 2023-01-31

Outcome

Met primary endpoint

paper 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 PMID 39843169 ↗

paper risk ratio 1.56, 95% confidence interval (CI) 1.17 to 2.09; P=0.002) over 12 months, meeting the predefined primary endpoint. PMID 39843169 ↗

Publications

Liu Y, Chen Y, Ma J, Lin J, Liu C, Li X, Xu Y, Kuang H, Shi L, Xue Y, Feng B, Zhu D, Wang G, Yang J, Xiao X, Yu X, Zhou J, Bao Y, Su Q, Lyu M, Li X, Zhang H, Li X. Dapagliflozin plus calorie restriction for remission of type 2 diabetes: multicentre, double blind, randomised, placebo controlled trial. BMJ. 2025 Jan 22;388:e081820. doi: 10.1136/bmj-2024-081820.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Dapagliflozin	Small molecule	10 mg	Oral