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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
328
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).
The treatment of Dapagliflozin (Forxiga®) will be initiated and maintained at 10mg every morning until the completion of the study.
Shanghai Medical college of
Shanghai, China
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
Time frame: During the 12-month intervention
Proportion of patients with diabetes remission
Time frame: during the 12-month intervention
Net change in body weight
Time frame: during both 12 and 14 months
Net change in waist circumference
Time frame: during both 12 and 14 months
Net change in HOMA-IR
Time frame: during both 12 and 14 months
Net change in serum lipids
Time frame: during both 12 and 14 months
Net change in HbA1c
Time frame: during both 12 and 14 months
Net change in body fat
Time frame: during both 12 and 14 months
Net change in SBP
Time frame: during both 12 and 14 months
Net change in Serum Creatine
Time frame: during both 12 and 14 months
Net change in Albuminuria
Time frame: during both 12 and 14 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
The treatment of placebo will be initiated and maintained at 10mg every morning until the completion of the study.