NCT00960076已完成3 期
18-Week, Multicenter, Randomized, Double-Blind 3b Trial to Evaluate Efficacy/Safety of Saxagliptin in Combo With Metformin XR 1500mg vs Metformin Uptitrated to 2000mg in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control After Diet/Exercise and a Stable Dose of Metformin XR 1500mg
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 282
- 试验地点
- 1
- 主要终点
- Change in HbA1c Level From Baseline to Week 18 (LOCF)
研究概览
简要总结
The purpose of this study is to compare reduction in A1C for subjects taking Saxagliptin and Metformin XR vs. uptitrated Metformin XR.
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 78 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetics taking metformin IR or XR greater than or equal to 850mg and less than or equal to 1500mg only for at least 8 weeks prior to screening
- •A1c: 7.5-11% (at screening)
- •BMI less than or equal to 45 kg/m2
排除标准
- •Significant cardiovascular history
- •Active liver disease, renal impairment
研究组 & 干预措施
1
Experimental
Saxagliptin
干预措施: Saxagliptin (Drug)
1
Experimental
Saxagliptin
干预措施: Metformin XR (Drug)
2
Active Comparator
Metformin Extended Release
干预措施: Metformin XR (Drug)
结局指标
主要结局
Change in HbA1c Level From Baseline to Week 18 (LOCF)
时间窗: Baseline to week 18
Adjusted mean change from baseline in HbA1c achieved with saxagliptin added on to metformin versus metformin at Week 18 (Randomized 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
- Change in 2-hour PPG Following Mixed Meal Tolerance Test (MMTT) From Baseline to Week 18 (LOCF)(Baseline to week 18)
- Change in FPG From Baseline to Week 18 (LOCF)(Baseline to week 18)
- Percent of Subjects Reaching Goal (HbA1c <7%) at Week 18 (LOCF) - Percent of Subjects (1)(Week 18 (LOCF))
研究者
研究点 (1)
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