A Phase III, Multicenter, Randomized, Open-label Clinical Trial Comparing the Efficacy and Safety of a Sitagliptin-Based Treatment Paradigm to a Liraglutide-Based Treatment Paradigm in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin Monotherapy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 653
- 主要终点
- Change From Baseline in Hemoglobin A1c (A1C)
研究概览
简要总结
This study is being done to compare the effectiveness and safety of two treatment paradigms (oral sitagliptin with or without glimepiride versus liraglutide with or without increased dosing) for the treatment of participants with Type 2 Diabetes that is not adequately controlled with metformin alone. The primary hypothesis postulated that the mean change from baseline in hemoglobin A1c (A1C) in participants treated with a sitagliptin-based treatment is non-inferior to that of participants treated with a liraglutide-based
treatment.
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
- None
入排标准
- 年龄范围
- 18 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Sitagliptin +/- glimepiride
Sitagliptin 100 mg tablet orally once daily for 26 weeks. Participants continued their stable dose of metformin >=1500 mg orally daily. Participants may have received glimepiride orally for glycemic control.
干预措施: sitagliptin (Drug)
Sitagliptin +/- glimepiride
Sitagliptin 100 mg tablet orally once daily for 26 weeks. Participants continued their stable dose of metformin >=1500 mg orally daily. Participants may have received glimepiride orally for glycemic control.
干预措施: glimepiride (Drug)
Sitagliptin +/- glimepiride
Sitagliptin 100 mg tablet orally once daily for 26 weeks. Participants continued their stable dose of metformin >=1500 mg orally daily. Participants may have received glimepiride orally for glycemic control.
干预措施: metformin (Drug)
Liraglutide
Liraglutide subcutaneous injection once daily for 26 weeks (starting dose 0.6 mg daily up-titrated to 1.2 mg daily on Day 8). Participants continued their stable dose of metformin >=1500 mg orally daily. Participants may have had their liraglutide dose uptitrated to 1.8 mg daily for glycemic control.
干预措施: liraglutide (Drug)
Liraglutide
Liraglutide subcutaneous injection once daily for 26 weeks (starting dose 0.6 mg daily up-titrated to 1.2 mg daily on Day 8). Participants continued their stable dose of metformin >=1500 mg orally daily. Participants may have had their liraglutide dose uptitrated to 1.8 mg daily for glycemic control.
干预措施: metformin (Drug)
结局指标
主要结局
Change From Baseline in Hemoglobin A1c (A1C)
时间窗: Baseline and Week 26
A1C is measured as percent. Thus, this change from baseline reflects the Week 26 A1C percent minus the Week 0 A1C percent.
次要结局
- Change From Baseline in Fasting Plasma Glucose (FPG)(Baseline and Week 26)
- Percentage of Participants Reaching A1C Goal of <7.0%(Week 26)
- Percentage of Participants Reaching A1C Goal of <6.5%(Week 26)