A Multicenter, Double-Blind, Randomized, Placebo and Active Comparator Controlled Dose-Range Finding Study of MK0893 in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 342
- 主要终点
- Change From Baseline to Week 12 in Fasting Plasma Glucose (FPG)
研究概览
简要总结
A study to compare MK0893 to metformin or placebo for patients with Type 2 diabetes (Diabetes Mellitus).
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
- 21 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who have Type 2 Diabetes Mellitus, with suboptimal glucose control, while either not on AHA (antihyperglycemic agent) therapy or on monotherapy or on low-dose combination therapy
排除标准
- •Patients have a history of Type 1 Diabetes Mellitus
- •Patients taking insulin or thiazolidinedione (TZD, a peroxisome proliferator-activated receptor [PPAR]-gamma agonist)
- •Patients who have a contraindication to metformin
研究组 & 干预措施
MK0893 40 mg
MK0893 40 mg tablet once daily.
干预措施: MK0893 (Drug)
MK0893 80 mg
MK0893 tablets totaling 80 mg once daily.
干预措施: MK0893 (Drug)
MK0893 80 mg
MK0893 tablets totaling 80 mg once daily.
干预措施: Placebo to MK0893 (Drug)
MK0893 80 mg
MK0893 tablets totaling 80 mg once daily.
干预措施: Placebo to Metformin (Drug)
MK0893 60 mg
MK0893 tablets totaling 60 mg once daily.
干预措施: MK0893 (Drug)
MK0893 60 mg
MK0893 tablets totaling 60 mg once daily.
干预措施: Placebo to MK0893 (Drug)
MK0893 60 mg
MK0893 tablets totaling 60 mg once daily.
干预措施: Placebo to Metformin (Drug)
MK0893 40 mg
MK0893 40 mg tablet once daily.
干预措施: Placebo to MK0893 (Drug)
MK0893 40 mg
MK0893 40 mg tablet once daily.
干预措施: Placebo to Metformin (Drug)
MK0893 20 mg
MK0893 20 mg tablet once daily.
干预措施: MK0893 (Drug)
MK0893 20 mg
MK0893 20 mg tablet once daily.
干预措施: Placebo to MK0893 (Drug)
MK0893 20 mg
MK0893 20 mg tablet once daily.
干预措施: Placebo to Metformin (Drug)
Metformin
Metformin HCL 500 mg tablet twice daily BID titrating up to 1000 mg twice daily over 3 weeks.
干预措施: Metformin (Drug)
Metformin
Metformin HCL 500 mg tablet twice daily BID titrating up to 1000 mg twice daily over 3 weeks.
干预措施: Placebo to MK0893 (Drug)
Placebo
PLA tablets. 12 week treatment period.
干预措施: Placebo to MK0893 (Drug)
Placebo
PLA tablets. 12 week treatment period.
干预措施: Placebo to Metformin (Drug)
结局指标
主要结局
Change From Baseline to Week 12 in Fasting Plasma Glucose (FPG)
时间窗: Week 12
次要结局
- Change From Baseline to Week 12 in Hemoglobin A1c (HbA1c)(Week 12)
- Change From Baseline to Week 12 in 2-Hour Post Prandial Glucose (PPG)(Week 12)