A Randomized, Double-blind Dose-ranging Study of the Effect of DPP-IV on HbA1c, Other Efficacy Parameters, Pharmacokinetics and Safety in Patients With Type 2 Diabetes (BC20779)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 289
- 主要终点
- Absolute change in hemoglobin A1c (HbA1c)
研究概览
简要总结
This 5 arm study will assess the efficacy, pharmacokinetics, safety and tolerability of a DPP-IV inhibitor compared to placebo in patients with type 2 diabetes. Patients will be randomized to receive DPP-IV(3) at one of 4 doses (of 12.5mg and above), or placebo p.o. Patients receiving metformin before the study will continue on the same dose of metformin. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adult patients, 18-75 years of age;
- •type 2 diabetes diagnosed >= 1 month before screening;
- •drug-naive, or pretreated with maximum tolerated dose (MTD) of metformin;
- •BMI 25-45kg/m2.
排除标准
- •type 1 diabetes;
- •any anti-hyperglycemic medication other than metformin, or weight-lowering drug, during last 3 months.
研究组 & 干预措施
RO4876904 1
Escalating doses, at a starting dose of 12.5mg po daily. Patients receiving metformin before the study will continue on the same dose of metformin.
干预措施: RO4876904 (Drug)
RO4876904 2
Escalating doses, at a starting dose of 12.5mg po daily. Patients receiving metformin before the study will continue on the same dose of metformin.
干预措施: RO4876904 (Drug)
RO4876904 3
Escalating doses, at a starting dose of 12.5mg po daily. Patients receiving metformin before the study will continue on the same dose of metformin.
干预措施: RO4876904 (Drug)
RO4876904 4
Escalating doses, at a starting dose of 12.5mg po daily. Patients receiving metformin before the study will continue on the same dose of metformin.
干预措施: RO4876904 (Drug)
Placebo
Placebo po daily. Patients receiving metformin before the study will continue on the same dose of metformin.
干预措施: Placebo (Drug)
结局指标
主要结局
Absolute change in hemoglobin A1c (HbA1c)
时间窗: Week 12
次要结局
- Absolute change in fasting plasma glucose (FPG), HbA1c response rate, absolute/relative change in insulin sensitivity, beta cell function, lipid profile.(Week 12)
- Adverse events (AEs), vital signs, laboratory parameters.(Throughout study)