NCT00257257已完成3 期
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Fixed-Dose (Rimonabant 20 mg) Multicenter Study of Long-Term Glycemic Control With Rimonabant in Treatment-naïve Patients With Type 2 Diabetes
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
- 281
- 试验地点
- 8
- 主要终点
- Absolute change in HbA1C from baseline to Month 6.
研究概览
简要总结
Primary: Effect on HbA1c over 6 months in drug-naive patients with type 2 diabetes
Secondary: Effect on glucose, insulin, C-peptide, insulin resistance, body weight, HDL-cholesterol, triglycerides, blood pressure - Safety, tolerability
详细描述
The total duration of the study will be up to 6 and 1/2 months including screening period (up to 14 days) and double-blind treatment period (approximately 6 months) in patients on mild hypocaloric diet (600 kcal/day deficit).
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
- •Male or female patients aged greater than or equal to 18 years.
- •Diagnosis of type 2 diabetes as defined by WHO criteria for at least 2 months but no longer than 3 years.
- •Type 2 diabetes not previously treated by a pharmacological agent.
- •a) insulin use is accepted if it is not within 6 months prior to screening visit and only for the following reasons:
- •prior use for management of gestational diabetes,
- •short-term (less than or equal to 1 month) use to maintain glycemic control for hospitalization, medical procedures, or intervention.
- •b) use of an oral antidiabetic agent is accepted if it is not within 6 months prior to screening visit and only if it was prescribed for no more than 4 months.
- •HbA1C greater than or equal to 7% and less than or equal to 10%.
- •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.
- •Marijuana or hashish users.
- •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.
- •Presence of any other condition (e.g., geographic, social) that the Investigator feels that would restrict or limit the patient's participation for the duration of the study.
- •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 five 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).
- •Hemoglobin < 11 g/dL and/or neutrophils < 1,500/mm3 and/or platelets < 100,000/mm
- •Positive urine pregnancy test.
- •Positive urine test for marijuana or hashish metabolites.
- •Related to previous or concomitant medications:
- •Oral antidiabetic agent except if it is not within 6 months prior to screening visit and only if it was prescribed for no more than 4 months.
- •Insulin except if it is not within 6 months prior to screening visit and only for management of gestational diabetes or short-term use to maintain glycemic control for hospitalization, medical procedures, or intervention.
- •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 Month 6.
次要结局
- Fasting glucose, fasting insulin, C-peptide, HOMA analysis, body weight, HDL-cholesterol, triglycerides, blood pressure, safety (physical examination, vital signs, laboratory tests, adverse events).
研究者
研究点 (8)
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