A Randomized, Double-Blind, Parallel-Group, Multicenter, Multinational Study to Assess Glycemic Control With Rimonabant in Comparison With Glimepiride Over 1 Year in Overweight/Obese Type2 Diabetic Patients Not Adequately Controlled With Metformin
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- Sanofi
- 入组人数
- 508
- 试验地点
- 2
- 主要终点
- Change from baseline in glycemic measure HbA1c
研究概览
简要总结
The primary objective is to demonstrate, after 52 weeks of treatment, the non-inferiority of rimonabant 20 mg once daily (od) versus glimepiride od in reducing glycosylated haemoglobin (HbA1c) in overweight/obese patients with type 2 diabetes not adequately controlled with metformin at a stable dose (≥ 1500 mg/day) for at least 3 months.
The main secondary objectives are to assess the effect of rimonabant in comparison with glimepiride on body weight and HDL-Cholesterol and the long-term safety and tolerability of rimonabant in comparison with glimepiride.
详细描述
The total duration per patient will be approximately 65 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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with legal age
- •Body Mass Index >27kg/m2
- •Type 2 diabetes as defined by World Health Organization (WHO) criteria, treated with metformin for at least 6 months and with a stable dose of metformin >=1500 mg/day for at least three months
- •HbA1c >=7% and <=9% at screening visit
排除标准
- •Weight loss > 5 kg within three months prior to screening
- •Presence of any clinically significant endocrine disease according to the Investigator
- •Presence of type 1 diabetes
- •Presence or history of cancer within the past 5 years with the exception of adequately-treated localized basal cell skin cancer or in situ uterine cervical cancer
- •Previous participation in a clinical study with rimonabant
- •Absence of effective medical contraceptive method for females of childbearing potential
- •Within 3 months prior to screening visit: use of oral antidiabetic drugs (other than metformin) and/or insulin, of anti-obesity drugs or other drugs for weight reduction
- •Within 2 months 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
- •Presence of any severe medical or psychological condition or chronic conditions/infections that in the opinion of the Investigator would compromise the patient's safety or successful participation in the study, including uncontrolled serious psychiatric illness
- •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)
Glimepiride
Glimepiride from 1 mg up to 6 mg once daily on top of metformin
干预措施: Glimepiride (Drug)
Glimepiride
Glimepiride from 1 mg up to 6 mg once daily on top of metformin
干预措施: Metformin (Drug)
结局指标
主要结局
Change from baseline in glycemic measure HbA1c
时间窗: 52 weeks (1 year)
次要结局
- Relative change from baseline in HDL-C(52 weeks)
- Absolute change from baseline in body weight(52 weeks)