Remission of Type 2 Diabetes With Dapagliflozin (READ Trial)

NCT04004793 | Completed Phase 4

• 1 other identifier: ZSE-201901
• Study Type: interventional
• Target: 328
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

• Incidence of patients with diabetes remission

  Diabetes remission is defined as a HbA1c\<6.5% and a fasting glucose level of \<7.0 mmol/l in the absence of all antidiabetic medication for at least 2 months

  During the 12-month intervention

Secondary Outcomes (10)

• Proportion of patients with diabetes remission

  during the 12-month intervention

• Net change in body weight

  during both 12 and 14 months

• Net change in waist circumference

  during both 12 and 14 months

• Net change in HOMA-IR

  during both 12 and 14 months

• Net change in serum lipids

  during both 12 and 14 months

Study Arms (2)

Dapagliflozin plus intensive lifestyle intervention

EXPERIMENTAL

The treatment of Dapagliflozin (Forxiga®) will be initiated and maintained at 10mg every morning until the completion of the study.

Behavioral: Intensive lifestyle intervention; Drug: Dapagliflozin 10 MG Oral Tablet

Placebo plus intensive lifestyle intervention

PLACEBO COMPARATOR

The treatment of placebo will be initiated and maintained at 10mg every morning until the completion of the study.

Behavioral: Intensive lifestyle intervention; Drug: Placebo Oral Tablet

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 plus intensive lifestyle intervention; Placebo plus intensive lifestyle intervention

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.

Dapagliflozin plus intensive lifestyle intervention

Placebo Oral Tablet DRUG

The treatment of placebo will be initiated and maintained at 10mg every morning until the completion of the study.

Placebo plus intensive lifestyle intervention

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men or women aged 20-70 years old who had a BMI ≥25 kg/m2.
• Subjects had been diagnosed with type 2 diabetes within 6 years
• HbA1C ≥6.5% and ≤10.0% at screening if on treatment with metformin alone or without antidiabetic agents, or HbA1C \<6.5% at screening if on metformin treatment alone
• Able and willing to provide written informed consent and to comply with the study

You may not qualify if:

• Patients have a history of myocardial infarction, unstable angina, cardiac surgery or revascularization (coronary artery bypass graft/percutaneous transluminal coronary angioplasty), or congestive heart failure New York Heart Association Class III or IV.
• Current insulin use.
• Weight loss of more than 5kg within the past 6 months.
• Women who are pregnant or plan to become pregnant.
• Diagnosis or history of acute metabolic diabetic complications such as ketoacidosis or hyperglycemic hyperosmolar state, or diabetes insipidus within 30 days.
• Alcohol or drug abuse within the 3 months prior to informed consent that would interfere with trial participation or any ongoing condition leading to a decreased compliance to study procedures or study drug intake.
• Intake of an investigational drug in another trial within 30 days prior to intake of study medication in this trial or participating in another trial (involving an investigational drug and /or follow-up).
• Patients with clinically apparent hepatobiliary disease, including but not limited to chronic active hepatitis and/or severe hepatic insufficiency. ALT or AST \> 3x upper limit of normal (ULN), or serum total bilirubin (TB) \>34.2 μmol/L (\>2 mg/dL).
• Patients with severe renal impairment or end-stage renal disease (eGFR\< 45 mL/min/1.73 m2).
• Bariatric surgery within the past two years and other gastrointestinal surgeries that induce chronic malabsorption.
• Malignancy within 5 years of the enrollment visit.
• Known immunocompromised status, including but not limited to, individuals who had undergone organ transplantation or acquired immunodeficiency syndrome (AIDS).
• History of bone fracture secondary to diagnosed severe osteoporosis.
• Current treatment with systemic steroids at time of informed consent or change in dosage of thyroid hormones within 6 weeks prior to informed consent or any other uncontrolled endocrine disorder except T2DM.
• Administration of sibutramine, phentermine, orlistat, rimonabant, benzphetamine, diethylpropion, methamphetamine, or phendimetrazine within 30 days of enrollment visit.

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

Study Sites (1)

Shanghai Medical college of

Shanghai, 200032, China

Location

Related Publications (1)

• 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.

  PMID: 39843169 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

dapagliflozin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Xiaoying Li, MD

  Fudan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Medical doctor

Study Record Dates

• First Submitted: June 28, 2019
• First Posted: July 2, 2019
• Study Start: June 12, 2020
• Primary Completion: January 31, 2023
• Study Completion: January 31, 2023
• Last Updated: July 24, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)