Remission of Type 2 Diabetes With Dapagliflozin (READ Trial)

Sponsor
Shanghai Zhongshan Hospital
Study ID
NCT04004793
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
20 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Intensive lifestyle intervention — BEHAVIORAL
    Participants were will be asked to follow a weight management programme, in accordance with the American Diabetes Association guidelines. Weight loss will be induced with a diet replacement phase using an energy restriction diet (energy deficit by 500\~750 kcal/day) for 3 months, with \<35% as fat, \>15% as protein. The minimum energy intake is 1200kcal/day for men and 1000kcal/day for women.. Additionally, participants were encouraged to increase physical exercise (≥150 minutes of brisk walking every week or ≥10000 steps per day).
  • Dapagliflozin 10 MG Oral Tablet — DRUG
    The treatment of Dapagliflozin (Forxiga®) will be initiated and maintained at 10mg every morning until the completion of the study.
  • Placebo Oral Tablet — DRUG
    The treatment of placebo will be initiated and maintained at 10mg every morning until the completion of the study.

Study Details

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.

Key Dates

Start date
Jun 12, 2020
Status verified
Jul 2024
Primary completion
Jan 31, 2023
Completion
Jan 31, 2023

Study Design

Enrollment
328 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Dapagliflozin plus intensive lifestyle intervention
    The treatment of Dapagliflozin (Forxiga®) will be initiated and maintained at 10mg every morning until the completion of the study.
  • Placebo Comparator: Placebo plus intensive lifestyle intervention
    The treatment of placebo will be initiated and maintained at 10mg every morning until the completion of the study.

Primary Outcome Measure

Incidence of patients with diabetes remission [ Time Frame: During the 12-month intervention ]

Related Studies