NCT00698932已完成3 期
A 24-Week International, Multi-centre, Randomized, Parallel-group, Double-blind, Placebo-controlled, Phase III Study to Evaluate the Efficacy and Safety of Saxagliptin in Adult Patients With Type 2 Diabetes Who Have Inadequate Glycaemic Control With Diet and Exercise.
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
- 568
- 试验地点
- 1
- 主要终点
- Absolute Change From Baseline to Week 24 in Glycosylated Haemoglobin A1c (HbA1c)
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 evaluate the efficacy and safety in adult patients with inadequate glycaemic control with diet and exercise.
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
- •Patients should be drug naïve ie, not received medical treatment for diabetes,
- •HbA1c ≥ 7.2% and ≤10.0% (at enrolment), HbA1c ≥ 7.0% and ≤10.0% (at randomization)
排除标准
- •Insulin therapy within one year of enrolment (with the exception of insulin therapy during a hospitalization or use in gestational diabetes),
- •Type 1 diabetes,history of ketoacidosis or hyperosmolar non-ketonic koma
研究组 & 干预措施
Saxagliptin 5mg
Experimental
干预措施: Saxagliptin (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Absolute Change From Baseline to Week 24 in Glycosylated Haemoglobin A1c (HbA1c)
时间窗: Baseline , Week 24
Adjusted\* mean change from baseline in HbA1c achieved with saxagliptin 5 mg versus placebo at week 24 (LOCF, Full Analysis set). HbA1c is a continuous measure, the change from baseline for each subject is calculated as the week 24 values minus the baseline value. HbA1c data were excluded on and after rescue medication.
次要结局
- Absolute Change (mmol/L) From Baseline to Week 24 in Fasting Plasma Glucose (FPG)(Baseline, Week 24)
- Absolute Change (mg/dL) From Baseline to Week 24 in Fasting Plasma Glucose (FPG)(Baseline, Week 24)
- Absolute Change (mmol*Min/L) From Baseline to Week 24 in Area Under the Curve (AUC) From 0 to 180 Minutes for Postprandial Glucose (PPG) During Mixed Meal (Instant Noodles) Tolerance Tests (MMTT) in All MMTT Participants(Baseline , Week 24)
- Absolute Change (mg*Min/dL) From Baseline to Week 24 in Area Under the Curve (AUC) From 0 to 180 Minutes for Postprandial Glucose (PPG) During Mixed Meal (Instant Noodles) Tolerance Tests (MMTT) in All MMTT Participants(Baseline , Week 24)
- Proportion of Patients Achieving a Therapeutic Glycemic Response Defined as HbA1c <7.0% at Week 24(Baseline, Week 24)
研究者
研究点 (1)
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