A Multicentre, Open-labelled, Randomized, Controlled Study to Evaluate the Efficacy of Metformin in Preventing Diabetes in China.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,724
- 试验地点
- 1
- 主要终点
- Rate of newly diagnosed diabetes
研究概览
简要总结
A multicentred, randomized, open study to evaluate the efficacy of metformin in preventing Diabetes.
详细描述
The increasing prevalence of prediabetes had been documented in the recent national surveillance in China. Prediabetes is an important risk factor for developing overt Diabetes and macro/micro vascular diseases. Pharmaceutical medications such as metformin had been proved effective in preventing Diabetes. Local studies are in need to guide the clinicians in their daily practice to prevent Diabetes in China. Therefore, China Diabetes Prevention Program（China DPP）is designed and conducted to compare the efficacy of metformin combined with lifestyle intervention versus lifestyle intervention alone in preventing Diabetes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of IGR before the randomization based on the 1999 WHO diagnostic and classification criteria.
- •Age: 18 ≤age≤70 years old.
- •Not on a treatment of anti-diabetic agents, including Chinese traditional herbs lowering blood glucose for at least 6 months before screening.
- •Male or non-pregnant, non-breastfeeding females, females without birthing plan in next three years.
- •Body mass index (BMI) ：21 kg/m2 ≤BMI<32 kg/m
- •Written informed consent given before any trial-related activities are carried out.
- •Main exclusion Criteria:
- •Administration with medications for pre-existed diseases affect glucose metabolism (except thiazide diuretics when its daily dose≤12.5mg).
- •Administration with anti-obesity agents (including Chinese traditional medicine) within 6 months of enrolment and during intervention.
- •Administration with three or more than three types antihypertensive drugs.
- •Diabetes patients (subjects with prior history of gestational Diabetes will not be excluded).
- •Have any of the following cardiovascular conditions within 3 months prior to the screening visit: acute myocardial infarction, congestive heart failure defined as New York Heart Association class III/IV or left ventricular ejection fraction ≤40%,) or cerebrovascular accident.
- •Persistent uncontrolled hypertension (systolic blood pressure ≥160mmHg, or diastolic blood pressure ≥100 mmHg).
- •Impaired liver function, have obvious clinical signs or symptoms of liver disease, acute or chronic hepatitis, ALT or AST levels ≥3 times the upper limit of the reference range at the screening visit.
- •Renal dysfunction (eGFR<45ml/min）.
- •Patients ventilated by ventilator.
- •Hypersensitivity to metformin or to any of the excipients such as povidone K 30, magnesium stearate and hypromellose.
- •Disease which may cause tissue hypoxia (especially acute disease, or worsening of chronic respiratory disease).
- •Acute alcohol intoxication, alcoholism.
- •Severe chronic gastrointestinal disease.
- •Severe psychiatric illness.
- •Cancer requiring treatment in past 5 years.
- •Uncontrolled thyroid diseases.
- •Women who are pregnant or breastfeeding .
- •Participation in another clinical trial within the past 30 days .
- •Other significant disease that in the Investigator's opinion would exclude the subject from the trial.
排除标准
- 未提供
研究组 & 干预措施
metformin plus standard lifestyle intervention
Metformin starting dose is 850mg/d, it will be titrated to 850mg twice daily after 2 weeks and maintained until the last subject completes 2 years' intervention.
干预措施: metformin (Drug)
Standard lifestyle intervention
Standard lifestyle advice will be united for all subjects by providing special booklet.
干预措施: Standard lifestyle intervention (Other)
结局指标
主要结局
Rate of newly diagnosed diabetes
时间窗: The primary outcome will be evaluated when the last subject completes 2 years' intervention.
次要结局
未报告次要终点