NCT01128153已完成3 期
A 24-week, Multicentre, Randomised, Double-Blind, Placebo-Controlled Phase IIIb Study to Evaluate Efficacy and Safety of Saxagliptin in Combination With Metformin and Sulfonylurea in Subjects With Type 2 Diabetes Who Have Inadequate Glycaemic Control With Combination of Metformin and Sulfonylurea
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
- 257
- 试验地点
- 1
- 主要终点
- Change in HbA1c From Baseline to Week 24, Last Observation Carried Forward (LOCF)
研究概览
简要总结
The purpose of this study is to determine whether the addition of saxagliptin to a patient's combination treatment of metformin and sulfonylurea for a 24 week period will provide better control of the patient's type 2 diabetes and will be well tolerated.
详细描述
A 24-week, Multicentre, Randomised, Double-Blind, Placebo-Controlled Phase IIIb Study to Evaluate Efficacy and Safety of Saxagliptin in Combination with Metformin and Sulfonylurea in Subjects with Type 2 Diabetes who have Inadequate Glycaemic Control with Combination of Metformin and Sulfonylurea
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
- •Written Informed Consent
- •Males or females with type 2 diabetes with inadequate glycaemic control (HbA1c > or = 7% and < or = 10%) despite being on combination of metformin and sulfonylurea for at least 8 weeks prior to Visit 1
- •BMI < or = 40 kg/m2
排除标准
- •Symptoms of poorly controlled diabetes including but not limited to marked polyuria and marked polydipsia with > 10% weight loss in 3 months prior to entry, or other signs and symptoms
- •History of diabetic ketoacidosis or hyperosmolar non-ketotic coma
- •Current or prior use within 3 months of Visit 1 of insulin, DDP4 inhibitor, GLP-1 analogues, and/or other oral anti-diabetic agents (other than metformin or sulfonylurea)
- •Treatment with CYP3A4 inducers and/or potent CYP3A4/5 inhibitor
- •Estimated CrCl < 60 ml/min at Visit 2
- •CHF (NYHA class III or IV) and/or LVEF <40%
- •Active liver disease and/or significant abnormal liver function defined as AST and/or ALT > 3 x ULN and/or bilirubin > 2.0 mg/dL at Visit
- •Creatine kinase > or = 10 x ULN at Visit 2
研究组 & 干预措施
Saxagliptin 5 mg once daily
Experimental
干预措施: Saxagliptin (Drug)
Placebo once daily
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Change in HbA1c From Baseline to Week 24, Last Observation Carried Forward (LOCF)
时间窗: From Baseline to Week 24 weeks
Adjusted Mean Change in HbA1c from baseline to Week 24 using analysis of covariance model
次要结局
- Change in Fasting Plasma Glucose (FPG) From Baseline to Week 24, Last Observation Carried Forward (LOCF) Measured as [mg/dL](From Baseline to Week 24)
- Change in 2-hour Postprandial Glucose (PPG) From Baseline to Week 24, Last Observation Carried Forward (LOCF) Measured as [mg/dL](From Baseline to Week 24)
- Change in 2-hour Postprandial Glucose (PPG) From Baseline to Week 24, Last Observation Carried Forward (LOCF) Measured as [mmol/L](From Baseline to Week 24)
- Change in Fasting Plasma Glucose (FPG) From Baseline to Week 24, Last Observation Carried Forward (LOCF) Measured as [mmol/L](From Baseline to Week 24)
- Proportion of Participants Achieving a Therapeutic Response: HbA1c Less Than 7% at Week 24, Last Observation Carried Forward (LOCF)(From Baseline to Week 24)
研究者
研究点 (1)
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