NCT00288236已完成3 期
A Multicenter, Randomized, Placebo-Controlled, Double-Blind, Parallel-Group, Fixed-Dose Study Evaluating the Effect of One Dose of Rimonabant (20 mg/Day) on Glycemic Control in Type 2 Diabetic Patients Inadequately Controlled With Insulin
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 368
- 试验地点
- 12
- 主要终点
- Absolute change in HbA1C from baseline to Week 48
研究概览
简要总结
Primary: Effect on HbA1c over 48 weeks in insulin-treated patients with type 2 diabetes
Secondary: Effect on glucose, total daily insulin dose, body weight, waist circumference, HDL-cholesterol, triglycerides - Safety, tolerability
详细描述
The total duration of the study will be up to 360 days including screening period (up to 14 days) and double-blind treatment period (approximately 11 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
- 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
- •Male or female patients aged greater than or equal to 18 years.
- •Diagnosis of type 2 diabetes as defined by WHO criteria.
- •Type 2 diabetes treated with insulin for at least 3 months (insulin dose of at least 30 U/day for at least 4 weeks).
- •HbA1C greater than or equal to 7%.
- •Having signed the informed consent form.
排除标准
- •Weight loss > 5 kg within 3 months prior to screening visit.
- •Pregnancy or lactation.
- •Absence of medically approved contraceptive methods for females of childbearing potential.
- •Administration of other investigational drugs within 30 days prior to screening visit.
- •Previous participation in a Rimonabant study.
- •Presence or history of allergic reaction or intolerance to multiple drugs.
- •Related to endocrine and metabolic disorders:
- •Presence of any clinically significant endocrine disease according to the Investigator.Note: euthyroid patients on replacement therapy will be included if the dosage of thyroxine is stable for at least 3 months prior to screening visit.
- •Fasting C-peptide < 1.0 ng/mL.
- •Related to other disorders:
- •Presence of any severe medical or psychological condition that in the opinion of the Investigator would compromise the patient's safety or successful participation in the study.
- •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.
- •Related to laboratory findings:
- •Positive test for hepatitis B surface antigen and/or hepatitis C antibody.
- •Abnormal TSH level (TSH > ULN or < LLN).
- •Positive urine pregnancy test.
- •Related to previous or concomitant medications:
- •Antidiabetic drugs other than insulin within 3 months prior to screening visit.
- •Drugs affecting weight (e.g., sibutramine, orlistat, herbal preparations, etc).
结局指标
主要结局
Absolute change in HbA1C from baseline to Week 48
次要结局
- Fasting glucose, total daily insulin dose, body weight, waist circumference, HDL-cholesterol, triglycerides, safety (physical examination, vital signs, laboratory tests, adverse events).
研究者
研究点 (12)
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