NCT00094770已完成3 期
A Multicenter, Double-Blind, Randomized Study to Evaluate the Safety and Efficacy of the Addition of MK0431 Compared With Sulfonylurea Therapy in Patients With Type 2 Diabetes With Inadequate Glycemic Control on Metformin Monotherapy
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,172
- 主要终点
- Change From Baseline in HbA1c at Week 52
研究概览
简要总结
The purpose of this investigational study is to determine the safety and effectiveness of an investigational drug in patients with type 2 diabetes mellitus (a specific type of diabetes).
详细描述
The duration of treatment is 104 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
- 18 Years 至 78 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who are at least 18 years of age and not older than 78 with type 2 diabetes mellitus
排除标准
- 未提供
研究组 & 干预措施
Sitagliptin 100 mg
Experimental
Sitagliptin 100 mg oral tablets of sitagliptin once daily.
干预措施: sitagliptin (MK0431) (Drug)
结局指标
主要结局
Change From Baseline in HbA1c at Week 52
时间窗: Baseline and Week 52
HbA1c is measured as percent. Thus, this change from baseline reflects the Week 52 HbA1c percent minus the Week 0 HbA1c percent.
次要结局
- Change From Baseline in HbA1c at Week 104(Baseline and Week 104)
- Hypoglycemic Events at Week 52(Baseline to Week 52)
- Number of Participants With Serious CAEs at Week 104(Baseline to Week 104)
- Number of Participants With Laboratory Adverse Experiences (LAEs) at Week 104(Baseline to Week 104)
- Change From Baseline in Body Weight at Week 52(Baseline and Week 52)
- Change From Baseline in Body Weight at Week 104(Baseline and Week 104)
- Number of Participants With Serious LAEs at Week 104(Baseline to Week 104)
- Number of Participants With Drug-related LAEs at Week 104(Baseline to Week 104)
- Hypoglycemic Events at Week 104(Baseline to Week 104)
- Number of Participants With Clinical Adverse Experiences (CAEs) at Week 104(Baseline to Week 104)
- Number of Participants With Drug-related CAEs at Week 104(Baseline to Week 104)
研究者
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