NCT00057304已完成2 期
A Phase II Randomized, Double-Blind, Dose-Ranging Study to Determine the Efficacy, Safety, Tolerability & Pharmacokinetics of RO 205-2349 in Patients With Type 2 Diabetes Mellitus
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 190
研究概览
简要总结
The objective of the study is to determine the dose(s) of Ro 205-2349 which, when compared to placebo, are efficacious, safe and tolerable in improving glycemic control in patients with type 2 diabetes. Doses of 2 to 5 mg/day will be studied.
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
- 35 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 35 to 75
- •Type 2 diabetes for longer than 3 months
- •HbA1c (glycosylated hemoglobin A1c) greater than 7.0% at screening
- •FPG (fasting plasma glucose) greater than 126 mg/dL at screening
- •BMI (body mass index) less than 40 kg/square meter
排除标准
- •Type I diabetes
- •Type 2 diabetes patients currently treated with insulin
- •Type 2 diabetes patients currently or previously treated with Actos, Avandia or Rezulin
- •FPG (fasting plasma glucose) greater than 270 mg/dL at baseline
- •Impaired liver or kidney function
- •Triglycerides greater than 600 mg/dL
- •Uncontrolled hypertension
- •Pregnant or lactating women
- •Women not using adequate contraception
研究组 & 干预措施
RO 205-2349 2 mg QD
Experimental
RO 205-2349 2 mg was taken once daily (QD) for 16 weeks during the double-blind treatment period.
干预措施: RO 205-2349 (Drug)
RO 205-2349 5 mg QD
Experimental
RO 205-2349 5 mg was taken once daily (QD) for 16 weeks during the double-blind treatment period.
干预措施: RO 205-2349 (Drug)
研究者
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