Remission of Type 2 Diabetes With Dapagliflozin (READ Trial)
NCT ID: NCT04004793
Last Updated: 2024-07-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
328 participants
INTERVENTIONAL
2020-06-12
2023-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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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.
Intensive lifestyle intervention
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
The treatment of Dapagliflozin (Forxiga®) will be initiated and maintained at 10mg every morning until the completion of the study.
Placebo plus intensive lifestyle intervention
The treatment of placebo will be initiated and maintained at 10mg every morning until the completion of the study.
Intensive lifestyle intervention
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).
Placebo Oral Tablet
The treatment of placebo will be initiated and maintained at 10mg every morning until the completion of the study.
Interventions
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Intensive lifestyle intervention
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
The treatment of Dapagliflozin (Forxiga®) will be initiated and maintained at 10mg every morning until the completion of the study.
Placebo Oral Tablet
The treatment of placebo will be initiated and maintained at 10mg every morning until the completion of the study.
Eligibility Criteria
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Inclusion Criteria
* 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
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.
11. Malignancy within 5 years of the enrollment visit.
12. Known immunocompromised status, including but not limited to, individuals who had undergone organ transplantation or acquired immunodeficiency syndrome (AIDS).
13. History of bone fracture secondary to diagnosed severe osteoporosis.
14. 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.
15. Administration of sibutramine, phentermine, orlistat, rimonabant, benzphetamine, diethylpropion, methamphetamine, or phendimetrazine within 30 days of enrollment visit.
16. Blood dyscrasias or any disorders causing haemolysis or unstable Red Blood Cell (e.g. malaria, babesiosis, haemolytic anaemia).
17. Administration of any other investigational drug within 30 days of planned enrollment to this study, or within 5 half-life periods of other investigational drugs.
18. Subject is, in the judgment of the Investigator, unlikely to comply with the protocol or has any severe concurrent medical or psychological condition that may affect the interpretation of efficacy or safety data
20 Years
70 Years
ALL
No
Sponsors
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Shanghai Zhongshan Hospital
OTHER
Responsible Party
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Xiaoying Li
Professor, Medical doctor
Principal Investigators
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Xiaoying Li, MD
Role: PRINCIPAL_INVESTIGATOR
Fudan University
Locations
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Shanghai Medical college of
Shanghai, , China
Countries
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References
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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.
Other Identifiers
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ZSE-201901
Identifier Type: -
Identifier Source: org_study_id
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