A Multicenter, Randomized, Double-Blind Factorial Study of the Co-Administration of MK0431 and Metformin in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,208
- 主要终点
- Change From Baseline in HbA1c (Hemoglobin A1C) at Week 24
研究概览
简要总结
The purpose of this study is to determine the safety and effectiveness of an investigational drug in patients with Type 2 Diabetes Mellitus (T2DM) (a specific type of diabetes).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 78 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •54-Week Base Study:
- •Patients between the ages of 18 and 78 with Type 2 Diabetes Mellitus (a specific type of diabetes)
- •50-Week Extension Study:
- •Patients who complete the 54-week base study are eligible to enter the 50-week extension study
排除标准
- •Patients who do not have Type 2 Diabetes Mellitus (a specific type of diabetes)
研究组 & 干预措施
1
MK0431 100 mg q.d.
干预措施: Comparator: MK0431 100 mg q.d. (q.d. = once daily) (Drug)
2
Metformin 500 mg b.i.d.
干预措施: Comparator: Metformin 500 mg b.i.d. (Drug)
3
Metformin 1000 mg b.i.d.
干预措施: Comparator: Metformin 1000 mg b.i.d. (Drug)
4
Coadministration of MK0431 and Metformin 50/500 mg b.i.d.
干预措施: Comparator: MK0431 50 mg b.i.d. (b.i.d. = twice daily) (Drug)
4
Coadministration of MK0431 and Metformin 50/500 mg b.i.d.
干预措施: Comparator: Metformin 500 mg b.i.d. (Drug)
5
Coadministration of MK0431 and Metformin 50/1000 mg b.i.d.
干预措施: Comparator: MK0431 50 mg b.i.d. (b.i.d. = twice daily) (Drug)
5
Coadministration of MK0431 and Metformin 50/1000 mg b.i.d.
干预措施: Comparator: Metformin 1000 mg b.i.d. (Drug)
6
Placebo/Metformin 1000 mg b.i.d.
干预措施: Comparator: Placebo (Phase A)/Metformin (Phase B) (Drug)
7
Non-Randomized, Open-Label: Coadministration MK0431 and Metformin 50/1000 mg b.i.d.
干预措施: Comparator: Open-Label MK0431/Metformin 50/1000 mg b.i.d. (Drug)
结局指标
主要结局
Change From Baseline in HbA1c (Hemoglobin A1C) at Week 24
时间窗: Week 24
HbA1c is measured as a percent. This change from baseline reflects the Week 24 HbA1c percent minus the Week 0 HbA1c percent.
次要结局
- Change From Baseline in HbA1c (Hemoglobin A1C) at Week 104(Week 104)
- Change From Baseline in FPG (Fasting Plasma Glucose) at Week 24(Week 24)
- Change From Baseline in 2-Hour PMG (Post-Meal Glucose) at Week 24(Week 24)
- Change From Baseline in HbA1c (Hemoglobin A1C) at Week 54(Week 54)
- Change From Baseline in FPG (Fasting Plasma Glucose) at Week 54(Week 54)
- Change From Baseline in 2-Hour PMG (Post-Meal Glucose) at Week 54(Week 54)
- Change From Baseline in FPG (Fasting Plasma Glucose) at Week 104(Week 104)
- Change From Baseline in 2-Hour PMG (Post-Meal Glucose) at Week 104(Week 104)