NCT00614939已完成3 期
A Short-term 12-Week, Multi-centre, Randomized, Parallel-group, Double-blind, Placebo-controlled Study to Evaluate the Treatment Effect of Saxagliptin Compared With Placebo in Adult Patients With Type 2 Diabetes and Renal Impairment (Moderate, Severe, and End-Stage) With an Additional 40-week, Randomized, Double-blind, Placebo-controlled Long-term Observational Period.
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
- 572
- 试验地点
- 1
- 主要终点
- Absolute Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) Level to Week 12 Last Observation Carried Forward (LOCF)
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 test the efficacy of once daily saxagliptin in renally impaired patients.
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
- Triple (Participant, Care Provider, Investigator)
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
- •Documented history of CrCl <50 ml/min within the 3 months prior to enrollment
- •HbA1c ≥7.0% and ≤11.0%
排除标准
- •Type 1 diabetes, history of diabetic ketoacidosis or hyposmolar non-ketonic coma
- •Previous or current treatment with any DPP-IV inhibitor and/or GLP-1 mimetic.
研究组 & 干预措施
Saxa
Experimental
Saxagliptin
干预措施: Saxagliptin (Drug)
Placebo
No Intervention
Placebo to match
干预措施: Placebo (Drug)
结局指标
主要结局
Absolute Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) Level to Week 12 Last Observation Carried Forward (LOCF)
时间窗: Baseline , Week 12 (LOCF)
Adjusted\* mean change from baseline in HbA1c achieved with saxagliptin 2.5 mg once daily versus placebo at Week 12 (Full Analysis Set). HbA1c is a continuous measure, the change from baseline for each participant is calculated at the Week 12 value minus the baseline value.
次要结局
- Absolute Change From Baseline in Fasting Plasma Glucose (FPG) to Week 12 (LOCF)- Moderate Renal Impairment Subgroup(Baseline, Week 12 (LOCF))
- Absolute Change From Baseline in Fasting Plasma Glucose (FPG) to Week 12 (LOCF) - Severe Renal Impairment Subgroup(Baseline, Week 12 (LOCF))
- Absolute Change From Baseline in Fasting Plasma Glucose (FPG) to Week 12 (LOCF) - End-Stage Renal Impairment Subgroup(Baseline, Week 12 (LOCF))
- Absolute Change From Baseline in Fasting Plasma Glucose (FPG) to Week 12 (LOCF) - Moderate Renal Impairment Subgroup(Baseline, Week 12 (LOCF))
- Absolute Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) Level to Week 52(Baseline , Week 52)
- Absolute Change From Baseline in Fasting Plasma Glucose (FPG) to Week 52 - Moderate Renal Impairment Subgroup(Baseline, Week 52)
- Absolute Change From Baseline in Fasting Plasma Glucose (FPG) to Week 52 - Severe Renal Impairment Subgroup(Baseline, Week 52)
- Absolute Change From Baseline in Fasting Plasma Glucose (FPG) to Week 52 - End-Stage Renal Impairment Subgroup(Baseline, Week 52)
研究者
研究点 (1)
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