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Remission of Type 2 Diabetes With Dapagliflozin (READ Trial) | Clinical Trials | Clareo Health

COMPLETEDPHASE4

Remission of Type 2 Diabetes With Dapagliflozin (READ Trial)

Effect of Dapagliflozin for Remission of Type 2 Diabetes Mellitus: A Multicenter, Randomized, Placebo-Controlled Trial

NCT04004793•Shanghai Zhongshan Hospital

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.

Detailed Description

Diabetes remission is an important issue which has not been well studied. Some studies showed that bariatric surgery and intensive lifestyle intervention could lead to remission in diabetic patients. Our present study aims to assess the effect of dapagliflozin add-on intensive lifestyle intervention on remission of type 2 diabetes in obese patients with type 2 diabetes. This is a multicenter, randomized, double-blind, placebo-controlled study. The study consists of a 12-months treatment period (in which subjects 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.

Eligibility

Age

20 - 70 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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

Exclusion Criteria

•1. 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.
•2. Current insulin use.
•3. Weight loss of more than 5kg within the past 6 months.
•4. Women who are pregnant or plan to become pregnant.
•5. Diagnosis or history of acute metabolic diabetic complications such as ketoacidosis or hyperglycemic hyperosmolar state, or diabetes insipidus within 30 days.
•6. 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.
•7. 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).
•8. 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).
•9. Patients with severe renal impairment or end-stage renal disease (eGFR\< 45 mL/min/1.73 m2).
•10. Bariatric surgery within the past two years and other gastrointestinal surgeries that induce chronic malabsorption.
+8 more criteria

Locations (1)

Shanghai Medical college of

Shanghai, China

Key Dates

Start Date

June 12, 2020

Primary Completion Date

January 31, 2023

Completion Date

January 31, 2023

Last Updated

July 24, 2024

Enrollment

328

ACTUAL participants

Conditions

Type 2 Diabetes

Interventions

Intensive lifestyle intervention

BEHAVIORAL

Dapagliflozin 10 MG Oral Tablet

DRUG

Placebo Oral Tablet

DRUG

Feasibility of a Tailored Online Self-compassion Intervention

NCT07051005

Type 1 Diabetes MellitusType 2 Diabetes Mellitus (T2DM)

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RECRUITINGPHASE2

Trial Against INtractable Type 2 Diabetes (CAPTAIN-T2D)

NCT07296484

Type 2 DiabetesCortisol Excess

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 24, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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Remission of Type 2 Diabetes With Dapagliflozin (READ Trial)

Inclusion Criteria

Exclusion Criteria

Feasibility of a Tailored Online Self-compassion Intervention

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