A Multicenter, Double Blind, Placebo Controlled Randomized Study of the Efficacy and Safety of Two Rimonabant/Metformin Combinations for Reducing A1C in the Treatment of Patients With Type 2 Diabetes Mellitus Who Are Not on Current Drug Therapy.
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- Sanofi
- 试验地点
- 1
- 主要终点
- Change from baseline in A1C
研究概览
简要总结
The primary objective of the study is to demonstrate superiority of rimonabant/metformin combinations in Glycosylated Hemoglobin 1c (A1C) reduction over the corresponding single agent metformin and over rimonabant alone in patients with type 2 diabetes mellitus at 9 months.
The secondary objective is to investigate the effects of rimonabant/metformin combinations for reducing fasted plasma glucose, body weight and triglycerides, and raising High Density Lipoprotein Cholesterol (HDL-C) in comparison with metformin at 9 months.
Another objective is to evaluate the safety of rimonabant in combination with metformin over a period of up to 52 weeks.
详细描述
The duration per patient is up to 65 weeks: 1 - 2 weeks screening, up to 52 weeks double blind treatment, and 75 days post last dose. This study will end for all patients when the last patient has been treated for at least 9 months.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •History of type 2 diabetes mellitus diagnosed prior to the screening visit 1 (ADA criteria)
- •Patients must not have used any oral or injectable glucose lowering medication at least 12 weeks prior to the screening visit to establish a stable, comparable baseline A1C assessment in all patients
- •A1C ≥7.0 % and ≤10.0 %
- •Fasted plasma glucose at screening visit ≤260 mg/dL (14.44 mmol/L)
排除标准
- •Treatment with any anti-diabetic oral agent, or injectable antidiabetic agent within 12 weeks prior to screening visit
- •In the 3 months prior to the screening visit, use of any anti-obesity agent or drugs for weight loss, or administration of systemic corticosteroids for more than 7 days
- •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
- •Presence or history of cancer within the past five years
- •Pregnant or breast-feeding women, or women of childbearing potential not protected by effective method of birth control
- •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
Arm 2
Metformin 1000mg bid + placebo
干预措施: placebo (Drug)
Arm 1
Metformin 500mg twice daily (bid) + placebo
干预措施: Metformin (Drug)
Arm 1
Metformin 500mg twice daily (bid) + placebo
干预措施: placebo (Drug)
Arm 2
Metformin 1000mg bid + placebo
干预措施: Metformin (Drug)
Arm 3
Rimonabant 20mg once daily (od) + placebo
干预措施: Rimonabant (Drug)
Arm 3
Rimonabant 20mg once daily (od) + placebo
干预措施: placebo (Drug)
Arm 4
Rimonabant 10mg bid (from week 2) in combination with metformin 500mg bid
干预措施: Rimonabant (Drug)
Arm 4
Rimonabant 10mg bid (from week 2) in combination with metformin 500mg bid
干预措施: Metformin (Drug)
Arm 5
Rimonabant 10mg bid (from week 2) in combination with metformin 1000mg bid
干预措施: Rimonabant (Drug)
Arm 5
Rimonabant 10mg bid (from week 2) in combination with metformin 1000mg bid
干预措施: Metformin (Drug)
结局指标
主要结局
Change from baseline in A1C
时间窗: at 9 months
次要结局
- Change from baseline in body weight(at 9 months)
- Percent change from baseline in triglycerides(at 9 months)
- Percent change from baseline in HDL-C(at 9 months)
- Change from baseline in fasting plasma glucose(at 9 months)