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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Xiaoying Li, MD | Fudan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Medical college of | Shanghai | 200032 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39843169 | Derived | 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. |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C529054 | dapagliflozin |
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|
| 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. |
|
| Placebo Oral Tablet | Drug | The treatment of placebo will be initiated and maintained at 10mg every morning until the completion of the study. |
|
| 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 |
| Net change in HbA1c | during both 12 and 14 months |
| Net change in body fat | during both 12 and 14 months |
| Net change in SBP | during both 12 and 14 months |
| Net change in Serum Creatine | during both 12 and 14 months |
| Net change in Albuminuria | during both 12 and 14 months |
| D004700 | Endocrine System Diseases |