NCT00361738已完成2 期
A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Dose-Response, Multicentre, Multinational Study Evaluating the Efficacy and Safety of AVE2268 Administered Either Twice Daily (Breakfast and Lunch) at a Dose of 300, 600 and 1200 mg or Once Daily (Breakfast) at a Dose of 1200 mg, in Patients With Type 2 Diabetes Treated With Metformin and Not Adequately Controlled
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 317
- 试验地点
- 11
- 主要终点
- Change in Mean Plasma Glucose (MPG) from baseline to week 4.
研究概览
简要总结
Dose-ranging study of AVE2268 in the management of patients with type 2 diabetes mellitus also receiving metformin.
Its main objectives will be to assess the effects of several doses of AVE2268 on Mean Plasma Glucose. Its secondary objectives will be to assess the effects of AVE2268 on plasma glucose (fasting and post-prandial), and also the safety and tolerability of AVE2268.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetes mellitus, as defined by the American Diabetes Association, for at least one year at the time of screening.
- •HbA1c measured at visit 1 in the range of ≥ 7.0 and < 9.0 %.
- •Stable metformin treatment (dose ≥ 1.5g/day for at least 3 months prior to enrollment in the study). No other antidiabetic medications are permitted for 3 months prior to enrollment.
排除标准
- •Pregnant or breast-feeding women.
- •Women of childbearing potential not protected by medically approved contraceptive method of birth control.
- •BMI >40kg/m2
- •Diabetes other than type 2 diabetes.
- •Subjects with "brittle-diabetes" or any hospitalization or emergency room visit due to poor diabetic control within the past 6 months, previous history of diabetes related dehydration leading to hospitalization, history or evidence of ketoacidosis.
- •Presence or history of cancer within the past five years.
- •Evidence within the past 6 months of myocardial infarction, stroke, retinopathy requiring laser surgery, or heart failure requiring hospitalization.
- •Impaired hepatic tests, impaired renal function.
- •History or evidence of clinically relevant renal or urological disorder.
- •The investigator will evaluate whether there are other reasons why a patient may not participate.
结局指标
主要结局
Change in Mean Plasma Glucose (MPG) from baseline to week 4.
次要结局
- Glucose parameters (change from baseline to week 4 in fasting and post prandial plasma glucose) ; Change in HbA1c and fructosamine ; Safety: physical examination, adverse events, ECG, laboratory tests
研究者
研究点 (11)
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