Effect of Dapagliflozin for Remission of Type 2 Diabetes Mellitus: A Multicenter, Randomized, Placebo-Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 328
- 试验地点
- 1
- 主要终点
- Incidence of patients with diabetes remission
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men or women aged 20-70 years old who had a BMI ≥25 kg/m
- •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
排除标准
- •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.
- •Current insulin use.
- •Weight loss of more than 5kg within the past 6 months.
- •Women who are pregnant or plan to become pregnant.
- •Diagnosis or history of acute metabolic diabetic complications such as ketoacidosis or hyperglycemic hyperosmolar state, or diabetes insipidus within 30 days.
- •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.
- •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).
- •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).
- •Patients with severe renal impairment or end-stage renal disease (eGFR< 45 mL/min/1.73 m2).
- •Bariatric surgery within the past two years and other gastrointestinal surgeries that induce chronic malabsorption.
- •Malignancy within 5 years of the enrollment visit.
- •Known immunocompromised status, including but not limited to, individuals who had undergone organ transplantation or acquired immunodeficiency syndrome (AIDS).
- •History of bone fracture secondary to diagnosed severe osteoporosis.
- •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.
- •Administration of sibutramine, phentermine, orlistat, rimonabant, benzphetamine, diethylpropion, methamphetamine, or phendimetrazine within 30 days of enrollment visit.
- •Blood dyscrasias or any disorders causing haemolysis or unstable Red Blood Cell (e.g. malaria, babesiosis, haemolytic anaemia).
- •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.
- •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
研究组 & 干预措施
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.
干预措施: Intensive lifestyle intervention (Behavioral)
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.
干预措施: Dapagliflozin 10 MG Oral Tablet (Drug)
Placebo plus intensive lifestyle intervention
The treatment of placebo will be initiated and maintained at 10mg every morning until the completion of the study.
干预措施: Intensive lifestyle intervention (Behavioral)
Placebo plus intensive lifestyle intervention
The treatment of placebo will be initiated and maintained at 10mg every morning until the completion of the study.
干预措施: Placebo Oral Tablet (Drug)
结局指标
主要结局
Incidence of patients with diabetes remission
时间窗: 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
次要结局
- Net change in body fat(during both 12 and 14 months)
- 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(during both 12 and 14 months)
- Net change in Serum Creatine(during both 12 and 14 months)
- Net change in HbA1c(during both 12 and 14 months)
- Net change in SBP(during both 12 and 14 months)
- Net change in Albuminuria(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)
研究者
Xiaoying Li
Professor, Medical doctor
Shanghai Zhongshan Hospital