Condition or disease | Intervention/treatment | Phase |
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Type 2 Diabetes | Behavioral: Intensive lifestyle intervention Drug: Dapagliflozin 10 MG Oral Tablet Drug: Placebo Oral Tablet | Phase 4 |
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 |
Actual Study Start Date : | August 15, 2020 |
Estimated Primary Completion Date : | November 30, 2022 |
Estimated Study Completion Date : | June 30, 2023 |
Arm | Intervention/treatment |
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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.
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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 Oral Tablet The treatment of Dapagliflozin (Forxiga®) will be initiated and maintained at 10mg every morning until the completion of the study.
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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.
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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.
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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 |
Inclusion Criteria:
Exclusion Criteria:
China | |
Shanghai Medical college of | |
Shanghai, China, 200032 |
Principal Investigator: | Xiaoying Li, MD | Fudan University |
Tracking Information | |||||
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First Submitted Date ICMJE | June 28, 2019 | ||||
First Posted Date ICMJE | July 2, 2019 | ||||
Last Update Posted Date | January 29, 2021 | ||||
Actual Study Start Date ICMJE | August 15, 2020 | ||||
Estimated Primary Completion Date | November 30, 2022 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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
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Original Primary Outcome Measures ICMJE |
The incidence of remission of diabetes [ 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
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Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Remission of Type 2 Diabetes With Dapagliflozin (READ Trial) | ||||
Official Title ICMJE | Effect of Dapagliflozin for Remission of Type 2 Diabetes Mellitus: A Multicenter, Randomized, Placebo-Controlled Trial | ||||
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. | ||||
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. | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 4 | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Triple (Participant, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE | Type 2 Diabetes | ||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Enrolling by invitation | ||||
Estimated Enrollment ICMJE |
328 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | June 30, 2023 | ||||
Estimated Primary Completion Date | November 30, 2022 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 20 Years to 70 Years (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | China | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT04004793 | ||||
Other Study ID Numbers ICMJE | ZSE-201901 | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Xiaoying Li, Shanghai Zhongshan Hospital | ||||
Study Sponsor ICMJE | Shanghai Zhongshan Hospital | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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PRS Account | Shanghai Zhongshan Hospital | ||||
Verification Date | January 2021 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |