A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Assess the Efficacy and Safety of SR141716 in Obese Type 2 Diabetic Patients on Monotherapy Inadequately Controlled With Oral Anti-diabetic Drug
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- Sanofi
- 入组人数
- 458
- 试验地点
- 1
- 主要终点
- Absolute change from baseline in HbA1C
研究概览
简要总结
The primary objective of this study is to assess the efficacy of Rimonabant (SR141716) compared to placebo on change in HbA1c and on relative change in body weight over 52 weeks in obese type 2 diabetic patients on monotherapy inadequately controlled with oral anti-diabetic drug (sulfonylurea or α-glucosidase inhibitor).
The secondary objectives are:
- To evaluate the effect of Rimonabant compared to placebo on other parameters related to the glucose control, waist circumference, Body Mass Index and metabolic parameters;
- To evaluate the safety and tolerability of Rimonabant compared to placebo;
- To evaluate the pharmacokinetics of Rimonabant.
详细描述
The total duration per patient will be approximately 69 weeks including a 52-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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 Diabetes Mellitus patients on monotherapy with oral anti-diabetic drug (sulfonylurea or α-glucosidase inhibitor)
- •HbA1C ≥ 7.0 % and ≤ 10.0 %
- •Body Mass Index ≥ 25 kg/m²
排除标准
- •Type 1 diabetes
- •Within 12 weeks prior to screening visit: use of oral antidiabetic drugs (other than a sulfonylurea or alpha-glucosidase inhibitor) and/or insulin, of anti-obesity drugs or other drugs for weight reduction
- •Within 4 weeks prior to screening visit: administration of systemic long-acting corticosteroids or prolonged use (more than one week) of other systemic corticosteroids, change in lipid lowering treatment
- •Secondary obesity
- •Primary hyperlipidemia
- •Positive serum pregnancy test in females of childbearing potential
- •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
干预措施: Rimonabant (Drug)
Rimonabant
Rimonabant 20 mg once daily
干预措施: Anti-diabetic monotherapy (Drug)
Placebo
Placebo (for Rimonabant) once daily
干预措施: Placebo (for Rimonabant) (Drug)
Placebo
Placebo (for Rimonabant) once daily
干预措施: Anti-diabetic monotherapy (Drug)
结局指标
主要结局
Absolute change from baseline in HbA1C
时间窗: Baseline to week 52
Relative change from baseline in in body weight
时间窗: Baseline to week 52
次要结局
- Absolute change from baseline in Fasting Plasma Glucose(Baseline to week 52)
- Relative change from baseline in Triglycerides and HDL-cholesterol(Baseline to week 52)
- Safety: overview of adverse events(Baseline to Week 56)
- Absolute change from baseline in waist circumference(Baseline to week 52)