NCT00575588已完成3 期
A 52-Week International, Multi-centre, Randomized, Parallel-group, Double-blind, Active-controlled, Phase III Study With a 52-Week Extension Period to Evaluate the Safety and Efficacy of Saxagliptin in Combination With Metformin Compared With Sulphonylurea in Combination With Metformin in Adult Patients With Type 2 Diabetes Who Have Inadequate Glycaemic Control on Metformin Therapy Alone.
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
- 891
- 试验地点
- 1
- 主要终点
- Hemoglobin A1c (HbA1c) Change From Baseline to Week 52
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 sulphonylurea 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 prior to Visit 1,
- •HbA1c >6.5% and ≤10.0%
排除标准
- •Type 1 diabetes,
- •history of diabetic ketoacidosis or hyperosmolar non-ketonic coma,
- •Insulin therapy within one year of enrolment (with the exception of insulin therapy during a hospitalization or use in gestational diabetes)
研究组 & 干预措施
Saxagliptin
Experimental
干预措施: Metformin (Drug)
Saxagliptin
Experimental
干预措施: Saxagliptin (Drug)
Glipizide
Experimental
干预措施: Metformin (Drug)
Glipizide
Experimental
干预措施: Sulphonylurea (Drug)
结局指标
主要结局
Hemoglobin A1c (HbA1c) Change From Baseline to Week 52
时间窗: Baseline to 52 Weeks
Adjusted mean change from baseline in HbA1c achieved with saxagliptin added on to metformin versus glipizide added on to metformin at Week 52 (Per Protocol Analysis Set). HbA1c is a continuous measure, the change from baseline for each participant is calculated as the Week 52 value minus the baseline value.
次要结局
- Proportion of Participants Reporting at Least One Episode of Any Hypoglycaemic Event Over 52 Weeks(From Baseline to Week 52)
- Body Weight Change From Baseline to Week 52(Baseline, Week 52 (Last Observation Carried Forward))
- Mean Slope of the Regressions of Change From Week 24 to Week 52 in HbA1c(Week 24 to Week 52)
研究者
研究点 (1)
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