A Randomized, Double Blind, Placebo Controlled Study Evaluating the Glycemic Effect of Rimonabant Added to Metformin in Patients With Type 2 Diabetes Insufficiently Controlled With Metformin Monotherapy
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- Sanofi
- 入组人数
- 403
- 试验地点
- 1
- 主要终点
- Change from baseline in HbA1c
研究概览
简要总结
The primary objective of the study is to determine the effect of rimonabant 20 mg daily when added to ongoing metformin therapy on glycemic control (HbA1c) over a 36 week period in patients with type 2 diabetes.
Secondary objectives include evaluation of other markers of glycemic control, lipid profile, body weight, and abdominal obesity. Also, the trial will study the safety of rimonabant when added to metformin over a period of 47 weeks.
详细描述
The total duration per patient will be approximately 49 weeks including a 36-week double-blind 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •History of type 2 diabetes
- •HbA1c between 7% to 10% at screening visit
- •Treatment with metformin only with a fixed and stable dose of 1500 mg/day or more for at least the past 3 months prior to screening visit
排除标准
- •Within 3 months prior to screening visit: change in lipid modifying agent, administration of systemic corticosteroids for more than 10 days, use of any anti-obesity agent or drugs for weight loss
- •Weight loss of more than 5 kg within 3 months prior to screening
- •Administration of other investigational drugs within 30 days prior to screening visit
- •Prior exposure to type 1 cannabinoid receptor (CB1) antagonists including rimonabant
- •Presence or history of cancer within the past five years
- •Pregnant or breast-feeding women
- •Presence of any severe medical or psychological condition that, in the opinion of the investigator, would compromise the patient's safe participation including uncontrolled serious psychiatric illness such a major depression within the last 2 years, and history of other severe psychiatric disorders.
- •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
研究组 & 干预措施
Rimonabant
Rimonabant 20 mg once daily on top of metformin
干预措施: Rimonabant (Drug)
Rimonabant
Rimonabant 20 mg once daily on top of metformin
干预措施: Metformin (Drug)
Placebo
Placebo (for Rimonabant) once daily on top of metformin
干预措施: Placebo (for Rimonabant) (Drug)
Placebo
Placebo (for Rimonabant) once daily on top of metformin
干预措施: Metformin (Drug)
结局指标
主要结局
Change from baseline in HbA1c
时间窗: 36 weeks
次要结局
- Percent change from baseline in HDL-C and Triglycerides(36 weeks)
- Change from baseline in fasting plasma glucose(36 weeks)
- Change from baseline in body weight(36 weeks)