18-wk, International, Multi-centre, Randomized, Parallel-group, Double-Blind, Active-Controlled Phase IIIb Study to Evaluate the Efficacy and Safety of Saxagliptin in Combination With Metformin in Comparison With Sitagliptin in Combination With Metformin in Adult Patients With T2D Who Have Inadequate Glycaemic Control on Metformin Alone
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 822
- 试验地点
- 1
- 主要终点
- Hemoglobin A1c (HbA1c) Change From Baseline to Week 18
研究概览
简要总结
Saxagliptin is a new investigational medication being developed for treatment of type 2 diabetes. This study is designed to assess the efficacy and tolerability of saxagliptin in addition to metformin and compare to sitagliptin in addition with 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Diagnosed with type 2 diabetes
- •Treatment with metformin alone on stable doses of 1500 mg or higher per day for at least 8 weeks
排除标准
- •Type 1 diabetes, history of diabetic ketoacidosis or hyperosmolar non-ketotic coma
- •Insulin therapy within one year
- •Previous treatment with DPP-4 inhibitor
研究组 & 干预措施
1
saxagliptin add-on to metformin
干预措施: saxagliptin (Drug)
2
sitagliptin add-on to metformin
干预措施: sitagliptin (Drug)
结局指标
主要结局
Hemoglobin A1c (HbA1c) Change From Baseline to Week 18
时间窗: Baseline, Week 18
Adjusted mean change from baseline in HbA1c achieved with saxagliptin added on to metformin versus sitagliptin added on to metformin at Week 18 (Per Protocol Analysis Set). HbA1c is a continuous measure, the change from baseline for each participant is calculated as the Week 18 value minus the baseline value.
次要结局
- Proportion of Patients Achieving Therapeutic Glycaemic Response Defined as HbA1c <= 6.5% at Week 18(Week 18 (Last Observation Carried Forward))
- Fasting Plasma Glucose Change From Baseline to Week 18 (mg/dL)(Baseline, Week 18 (Last Observation Carried Forward))
- Fasting Plasma Glucose Change From Baseline to Week 18 (mmol/L)(Baseline, Week 18 (Last Observation Carried Forward))