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Remission of Type 2 Diabetes With Dapagliflozin (READ Trial)

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ClinicalTrials.gov Identifier: NCT04004793
Recruitment Status : Not yet recruiting
First Posted : July 2, 2019
Last Update Posted : July 9, 2019
Sponsor:
Information provided by (Responsible Party):
Xiaoying Li, Shanghai Zhongshan Hospital

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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Behavioral: Intensive lifestyle intervention Drug: Dapagliflozin 10 MG Drug: Placebo oral tablet Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 328 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Dapagliflozin for Remission of Type 2 Diabetes Mellitus: A Multicenter, Randomized, Placebo-Controlled Trial
Estimated Study Start Date : August 1, 2019
Estimated Primary Completion Date : October 30, 2021
Estimated Study Completion Date : October 30, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Behavioral: 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).

Drug: Dapagliflozin 10 MG
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.
Behavioral: 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).

Drug: Placebo oral tablet
The treatment of placebo will be initiated and maintained at 10mg every morning until the completion of the study.




Primary Outcome Measures :
  1. Incidence of patients with diabetes remission [ Time Frame: During the 12-month intervention ]
    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


Secondary Outcome Measures :
  1. Proportion of patients with diabetes remission [ Time Frame: During the 12-month intervention ]
  2. Net change in body weight [ Time Frame: At both 12 and 14 months ]
  3. Net change in waist circumference [ Time Frame: At both 12 and 14 months ]
  4. Net change in HOMA-IR [ Time Frame: At both 12 and 14 months ]
  5. Net change in serum lipids [ Time Frame: At both 12 and 14 months ]
  6. Net change in HbA1c [ Time Frame: At both 12 and 14 months ]
  7. Net change in body fat [ Time Frame: At both 12 and 14 months ]
  8. Net change in SBP [ Time Frame: At both 12 and 14 months ]
  9. Net change in Serum Creatine [ Time Frame: At both 12 and 14 months ]
  10. Net change in Albuminuria [ Time Frame: At both 12 and 14 months ]


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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04004793


Contacts
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Contact: Xiaoying Li 0086-13651913857 xiaoying_li@hotmail.com

Sponsors and Collaborators
Shanghai Zhongshan Hospital

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Responsible Party: Xiaoying Li, Professor, Medical doctor, Shanghai Zhongshan Hospital
ClinicalTrials.gov Identifier: NCT04004793     History of Changes
Other Study ID Numbers: B2019-043R
First Posted: July 2, 2019    Key Record Dates
Last Update Posted: July 9, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
2-(3-(4-ethoxybenzyl)-4-chlorophenyl)-6-hydroxymethyltetrahydro-2H-pyran-3,4,5-triol
Sodium-Glucose Transporter 2 Inhibitors
Molecular Mechanisms of Pharmacological Action
Hypoglycemic Agents
Physiological Effects of Drugs