A Phase III, Randomized, Clinical Trial to Evaluate the Safety and Efficacy of the Addition of Sitagliptin in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on a Sulfonylurea in Combination With Metformin
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 427
- 主要终点
- Change From Baseline in Hemoglobin A1C (%) at Week 24
研究概览
简要总结
This study will evaluate whether the addition of Sitagliptin treatment provides a greater decrease in A1C levels compared to placebo in participants with inadequate glycemic control on sulfonylurea and metformin combination therapy.
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
- •Type 2 diabetes mellitus
- •Hemoglobin A1C of ≥7.5% and ≤10.5%
- •Currently taking a stable dose of metformin (at least 1500 mg/day) and either glimepiride (at least 2 mg/day) or gliclazide (at least 50% of maximum registered dose) for at least 10 weeks prior to study start
- •Male, or a female who is highly unlikely to conceive
排除标准
- •Type 1 diabetes mellitus or ketoacidosis
- •Taking a dipeptidyl peptidase-4 (DPP-4) inhibitor (such as sitagliptin) or a glucagon-like peptide-1 (GLP-1) mimetic (such as exenatide or liraglutide) or required insulin therapy within 12 weeks prior to study start
- •On a weight loss program not in the maintenance phase or on a weight loss medication
- •History of liver disease, heart failure, heart disease, stroke, high blood pressure, blood disorders, or cancer
- •HIV positive
研究组 & 干预措施
placebo/pioglitazone
Phase A (Weeks 0-24): placebo to Sitagliptin 100 mg; Phase B (Weeks 24-54): placebo to Sitagliptin 100 mg + pioglitazone 30 mg
干预措施: Glimepiride or gliclazide (Drug)
placebo/pioglitazone
Phase A (Weeks 0-24): placebo to Sitagliptin 100 mg; Phase B (Weeks 24-54): placebo to Sitagliptin 100 mg + pioglitazone 30 mg
干预措施: Metformin (Drug)
placebo/pioglitazone
Phase A (Weeks 0-24): placebo to Sitagliptin 100 mg; Phase B (Weeks 24-54): placebo to Sitagliptin 100 mg + pioglitazone 30 mg
干预措施: Pioglitazone rescue therapy (Drug)
Sitagliptin
Phase A (Weeks 0-24): Sitagliptin 100 mg; Phase B (Weeks 24-54): Sitagliptin 100 mg + placebo to pioglitazone
干预措施: Sitagliptin phosphate (Drug)
Sitagliptin
Phase A (Weeks 0-24): Sitagliptin 100 mg; Phase B (Weeks 24-54): Sitagliptin 100 mg + placebo to pioglitazone
干预措施: Glimepiride or gliclazide (Drug)
Sitagliptin
Phase A (Weeks 0-24): Sitagliptin 100 mg; Phase B (Weeks 24-54): Sitagliptin 100 mg + placebo to pioglitazone
干预措施: Metformin (Drug)
Sitagliptin
Phase A (Weeks 0-24): Sitagliptin 100 mg; Phase B (Weeks 24-54): Sitagliptin 100 mg + placebo to pioglitazone
干预措施: Pioglitazone rescue therapy (Drug)
结局指标
主要结局
Change From Baseline in Hemoglobin A1C (%) at Week 24
时间窗: Baseline and Week 24
Change from baseline reflects the Week 24 value minus the baseline value. A1C represents the percentage of glycosylated hemoglobin.
Number of Participants With One or More Adverse Events (AEs) - Week 0 to Week 54
时间窗: Week 0 to Week 54
Number of Participants Discontinuing Study Drug Due to An Adverse Event
时间窗: Week 0 to Week 54
次要结局
- Change From Baseline in 2-hour Post-Meal Glucose at Week 24(Baseline and Week 24)
- Change From Baseline in Fasting Plasma Glucose at Week 24(Baseline to Week 24)