NCT00631488已完成2 期
A Phase IIa, Multicenter, Double-Blind, Randomized, Active Comparator-Controlled Clinical Trial to Study the Efficacy and Safety of MK0893 in Combination With Sitagliptin or in Combination With Metformin in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control
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
- 146
- 主要终点
- Change From Baseline (BL) to Week 4 in 24-hour Weighted Mean Glucose (WMG) Levels
研究概览
简要总结
This study will test the effectiveness and safety of treatment with MK-0893 in combination with other drugs commonly used to treat type 2 diabetes for a duration up to 13 weeks.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants 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
- •Participants have a history of Type 1 Diabetes Mellitus
- •Participants taking insulin or thiazolidinediones (TZDs: peroxisome proliferator-activated receptor [PPAR]-gamma agonists)
- •Participants who have a contraindication to metformin or sitagliptin
研究组 & 干预措施
MK-0893 + Sitagliptin
Experimental
干预措施: MK-0893 (Drug)
MK-0893 + Sitagliptin
Experimental
干预措施: Sitagliptin (Drug)
MK-0893 + Sitagliptin
Experimental
干预措施: Placebo for Metformin (Drug)
MK-0893 + Metformin
Experimental
干预措施: MK-0893 (Drug)
MK-0893 + Metformin
Experimental
干预措施: Metformin (Drug)
MK-0893 + Metformin
Experimental
干预措施: Placebo for Sitagliptin (Drug)
Sitagliptin + Metformin
Active Comparator
干预措施: Sitagliptin (Drug)
Sitagliptin + Metformin
Active Comparator
干预措施: Metformin (Drug)
Sitagliptin + Metformin
Active Comparator
干预措施: Placebo for MK-0893 (Drug)
结局指标
主要结局
Change From Baseline (BL) to Week 4 in 24-hour Weighted Mean Glucose (WMG) Levels
时间窗: BL, 4 weeks (end of double-blind treatment period)
次要结局
- Change From BL to Week 4 in the 2-Hour Total GLP-1 Total AUC(BL, 4 weeks (end of double-blind treatment period))
- Change From BL to Week 4 in Fasting Plasma Glucose (FPG)(BL, 4 weeks (end of double-blind treatment period))
- Change From BL to Week 4 in 2-hr Glucose Area Under The Curve (AUC)(BL, 4 weeks (end of double-blind treatment period))
- Change From BL to Week 4 in the 2-Hour Active GLP-1 Total AUC(BL, 4 weeks (end of double-blind treatment period))
研究者
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