NCT01006590已完成4 期
A 24-Week, Randomised, Double-Blind, Active-Controlled, Multi-Centre Phase IIIb/IV Study to Evaluate the Efficacy and Tolerability of Saxagliptin Add-On Compared to Uptitration of Metformin in Patients With Type 2 Diabetes Mellitus With Inadequate Glycaemic Control on Sub-Maximal Doses of Metformin
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 286
- 试验地点
- 1
- 主要终点
- Absolute Change From Baseline in HbA1c at Week 24
研究概览
简要总结
The study will evaluate the efficacy and tolerability of saxagliptin compared to uptitration of metformin in patients with type 2 diabetes who have inadequate glycaemic control on a submaximal dose of 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
- 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
- •Provision of signed informed consent
- •Established clinical diagnosis of type 2 diabetes. Treatment with a stable dose of metformin monotherapy (1500-1700 mg/day) for at least 8 weeks prior to visit
- •HbA1c ≥7.0% and ≤10.0%
排除标准
- •Type 1 diabetes, history of diabetic ketoacidosis or hyperosmolar non-ketonic coma.
- •Renal impairment as defined by a creatinine clearance <60 mL/min/1.73 m2
- •Individuals who, in the opinion of the investigator, in which participation in this study may pose a significant risk to the patient and could render the patient unable to successfully complete the study
研究组 & 干预措施
1
Experimental
Saxagliptin 5 mg
干预措施: Saxagliptin (Drug)
2
Active Comparator
Metformin 500 -1000 mg
干预措施: Metformin (Drug)
结局指标
主要结局
Absolute Change From Baseline in HbA1c at Week 24
时间窗: Baseline and 24 weeks
次要结局
- Change From Baseline to Week 24 in Fasting Plasma Glucose(Baseline and 24 weeks)
- Proportion of Patients Achieving a Therapeutic Response at Week 24 Defined as HbA1c<7.0%(24 Weeks)
- Proportion of Patients Achieving a Therapeutic Response at Week 24 Defined as HbA1c<=6.5%(24 Weeks)
- Change From Baseline to Week 24 in Fasting Insulin(Baseline and 24 weeks)
- Change From Baseline to Week 24 in Beta-cell Function as Measured by Homeostasis Model Assessment-2-beta(Baseline and 24 weeks)
研究者
研究点 (1)
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