Efficacy and Safety of Alogliptin vs. Acarbose in Chinese T2DM Patients With High CV Risk or CHD Treated With Aspirin and Inadequately Controlled With Metformin Monotherapy or Drug Naive: A Multicenter, Randomized, Open Label, Prospective Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 1,293
- 试验地点
- 1
- 主要终点
- Overall Gastrointestinal tolerability
研究概览
简要总结
Primary Objectives:
- To assess efficacy in terms of change from baseline in Hemoglobin A1c (HbA1c) at the end of study between the two drugs.
- To assess tolerability in terms of overall Gastrointestinal (GI) tolerability for Alogliptin compared with acarbose during the whole treatment period.
Secondary Objectives:
- To assess efficacy in terms of the percentage of patients achieving HbA1c<7%.
- To assess efficacy in terms of percentage of patients achieving HbA1c<7% without GI effects.
- To assess change from baseline in Fasting plasma glucose (FPG), 2-h Post plasma glucose (2-h PPG), β-cell function (HOMA-β), lipids and body weight.
- To assess safety in terms of occurrence of hypoglycemia events.
- To assess safety in terms of other adverse events.
- To assess patient adherence and tolerability.
详细描述
The duration of the study for each patient will be approximately 17 weeks consisting of about 1 week screening period and 16-week treatment period.
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 —（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
Alogliptin
Single dose of alogliptin once daily for 16 weeks
干预措施: Alogliptin (Drug)
Alogliptin
Single dose of alogliptin once daily for 16 weeks
干预措施: Metformin (Drug)
Alogliptin
Single dose of alogliptin once daily for 16 weeks
干预措施: Aspirin (Drug)
Acarbose
Thrice daily dose of acarbose Dose 1 for 7 days then titrate to thrice daily dose of of acarbose Dose 2
干预措施: Acarbose (Drug)
Acarbose
Thrice daily dose of acarbose Dose 1 for 7 days then titrate to thrice daily dose of of acarbose Dose 2
干预措施: Metformin (Drug)
Acarbose
Thrice daily dose of acarbose Dose 1 for 7 days then titrate to thrice daily dose of of acarbose Dose 2
干预措施: Aspirin (Drug)
结局指标
主要结局
Overall Gastrointestinal tolerability
时间窗: Baseline to week 16
Incidence of any gastrointestinal adverse events during the whole treatment period.
Change in Hemoglobin A1c
时间窗: Baseline to week 16
Change from baseline in Hemoglobin A1c at the end of study (week 16) between the two drugs
次要结局
- Percentage of patients achieving HbA1c <7%(Baseline to Week 16)
- Other Adverse Events (AEs)(Baseline to Week 16)
- Overall tolerability(Baseline to Week 16)
- Change in Postprandial Plasma Glucose 2-h (PPG)(Baseline to Week 16)
- Change in High Density Lipoprotein-Cholesterol (HDL-C)(Baseline to Week 16)
- Change in Fasting Plasma Glucose (FPG)(Baseline to Week 16)
- Occurrence of hypoglycemia events(Baseline to Week 16)
- Change in Tri Glycerides (TG)(Baseline to Week 16)
- Change in Low Density Lipoprotein-Cholesterol (LDL-C)(Baseline to Week 16)
- Change in body weight(Baseline to Week 16)
- Medication possession ratio (MPR)(Baseline to Week 16)
- Percentage of patients achieving HbA1c <7% without gastrointestinal effects(Baseline to Week 16)
- Change in Homeostasis model assessment-β (HOMA- β)(Baseline to Week 16)
- Change in Total Cholesterol (TC)(Baseline to Week 16)
- Overall adherence to Investigational Medicinal Product (IMP)(Baseline to Week 16)