NCT00813995已完成3 期
A Phase III, Multicenter, Double-Blind, Placebo-Controlled, Randomized Study to Evaluate the Safety and Efficacy of the Addition of Sitagliptin 100 mg Once Daily in Patients With Type 2 Diabetes With Inadequate Glycemic Control on Metformin Monotherapy
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 395
- 主要终点
- Change From Baseline in Hemoglobin A1c (A1C) at Week 24
研究概览
简要总结
A study to assess the safety and efficacy of the addition of sitagliptin compared to placebo in patients with Type 2 Diabetes Mellitus who have inadequate glycemic control on metformin.
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
- •18 - 78 years of age
- •Currently on metformin monotherapy
排除标准
- •History of Type 1 diabetes mellitus or ketoacidosis
- •Currently on a weight loss program and not in the maintenance phase or has started on a weight loss medication within the last 8 weeks
- •Has undergone surgery requiring general anesthesia within the past 4 weeks or has planned major surgery
- •Currently participating in a study or has participated in a study with or without an investigational compound or device within the past 12 weeks
- •History of active liver disease such as chronic active hepatitis B or C, cirrhosis or symptomatic gallbladder disease
- •HIV positive
- •Pregnant, breast-feeding or planning to become pregnant during the study
- •User of recreational or illicit drugs or has a recent history (within the past year) of drug or alcohol abuse or dependence
结局指标
主要结局
Change From Baseline in Hemoglobin A1c (A1C) at Week 24
时间窗: Baseline and Week 24
A1C is measured as percent. Thus, this change from baseline reflects the Week 24 A1C percent minus the Week 0 A1C percent.
次要结局
- Change From Baseline in Hemoglobin A1c (A1C) at Week 24 for Participants on Metformin 1000 mg/Day(Baseline and Week 24)
- Change From Baseline in Hemoglobin A1c (A1C) at Week 24 for Participants on Metformin 1700 mg/Day(Baseline and Week 24)
- Change From Baseline in 2-hour Post-meal Glucose (PMG) at Week 24(Baseline and Week 24)
- Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24(Baseline and Week 24)
研究者
相似试验
已完成
3 期
Study to Assess Safety & Efficacy of Sitagliptin as Initial Oral Therapy for Treatment of Type 2 Diabetes Mellitus in Pediatric Participants. (MK-0431-083)Type 2 DiabetesDiabetes MellitusNCT01485614Merck Sharp & Dohme LLC200
已完成
3 期
A Study in China Evaluating the Safety and Efficacy of Adding Sitagliptin to Stable Therapy With Insulin With or Without Metformin in Participants With Type 2 Diabetes Mellitus (T2DM) (MK-0431-254)Type 2 Diabetes MellitusNCT01590797Merck Sharp & Dohme LLC467
已完成
3 期
A Study in China Evaluating the Safety and Efficacy of Adding Sitagliptin to Stable Therapy With Sulfonylurea With or Without Metformin in Participants With Type 2 Diabetes Mellitus (T2DM) (MK-0431-253)Type 2 Diabetes MellitusNCT01590771Merck Sharp & Dohme LLC498
已完成
3 期
Sitagliptin (MK-0431) vs. Placebo in Patients With Inadequate Glycemic Control on Metformin With Pioglitazone (MK-0431-128)Type 2 Diabetes MellitusNCT00885352Merck Sharp & Dohme LLC313
已完成
3 期
Safety and Efficacy of Sitagliptin Compared With Glimepiride in Elderly Participants With Type 2 Diabetes Mellitus (MK-0431-251)Type 2 Diabetes MellitusNCT01189890Merck Sharp & Dohme LLC480