A Multi-center, Double-blind, Randomized, Parallel Group, Placebo-controlled 12-week Study to Investigate Glycemic Parameters of Efficacy, Safety/ Tolerability and Pharmacokinetics of Five Dose Levels of RO4998452 in Patients With Type 2 Diabetes Mellitus
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 394
- 主要终点
- Absolute Change in HbA1c
研究概览
简要总结
This 6 arm study will evaluate the efficacy, safety and pharmacokinetics of 5 doses of RO4998452 compared to placebo in patients with type 2 diabetes mellitus. Patients will be randomized to one of 6 groups to receive RO4998452 at doses of 2.5mg, 5mg, 10mg, 20mg or 40mg po daily, or placebo daily. Patients pre-treated with stable metformin will continue to take their usual dose of metformin throughout the study.The anticipated time on study treatment is <=3 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
- 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 for >=3 months;
- •either treated with diet, exercise and stable metformin, or with diet and exercise alone.
排除标准
- •type 1 diabetes mellitus;
- •currently or within 2 months prior to screening treated with an oral or injectable anti-diabetic agent except stable doses of metformin;
- •currently or within 6 months prior to screening treated with any PPARgamma agonist;
- •uncontrolled hypertension;
- •significant pre-diagnosed diabetic complications requiring treatment.
研究组 & 干预措施
Placebo
During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast.
During the 12-week double-blind treatment period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test.
干预措施: Placebo (Drug)
RO4998452 10mg
During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test. The two capsules combined contained 10 mg of RO4998452.
干预措施: RO4998452 (Drug)
RO4998452 2.5mg
During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test. The two capsules combined contained 2.5 mg of RO4998452.
干预措施: RO4998452 (Drug)
RO4998452 20mg
During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test. The two capsules combined contained 20 mg of RO4998452.
干预措施: RO4998452 (Drug)
RO4998452 40mg
During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test. The two capsules combined contained 40 mg of RO4998452.
干预措施: RO4998452 (Drug)
RO4998452 5mg
During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test. The two capsules combined contained 5 mg of RO4998452.
干预措施: RO4998452 (Drug)
结局指标
主要结局
Absolute Change in HbA1c
时间窗: Baseline, Week 4, Week 8 and Week 12
次要结局
- Change From Baseline in Mean Daily Glucose Concentration (mmol/L)(Baseline and Week 12)
- Percentage of Participants Treated to Target HbA1c < 6.5%(Baseline up to 12 weeks)
- Change From Baseline in Fasting Plasma Glucose (mmol/L)(Baseline and Week 12)
- Percentage of Participants With at Least One Adverse Event(Baseline up to 12 weeks)
- Change From Baseline in Fructosamine Concentration (μmol/L)(Baseline and 12 weeks)
- Change From Baseline in Meal Tolerance Test: 0-3h Mean Glucose Concentration (mmol/L)(Baseline and Week 12)
- Change From Baseline in Meal Tolerance Test: 0-3h Urinary Glucose Excretion (mmol/L)(Baseline and Week 12)
- Change From Baseline in Meal Tolerance Test: 0-3h Mean Insulin Concentration (mmol/L)(Baseline and Week 12)
- Change From Baseline in Body Weight (kg)(Baseline and Week 12)
- Percentage of Participants Treated to Target HbA1c < 7%(Baseline up to 12 weeks)