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 Combination With Metformin in Adult Patients With Type 2 Diabetes Who Have Inadequate Glycaemic Control on Metformin Therapy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 570
- 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 who have inadequate glycaemic control when treated with metformin in addition to 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
- •Treatment with metformin at a stable dose >1500 mg/day
- •HbA1c ≥ 7.0% and ≤10.0%
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
1
Metformin + Saxagliptin
干预措施: Saxagliptin (Drug)
1
Metformin + Saxagliptin
干预措施: Metformin (Drug)
2
Metformin + Placebo
干预措施: Placebo (Drug)
2
Metformin + Placebo
干预措施: Metformin (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 + metformin versus placebo + metformin 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. \*Adjusted for baseline HbA1c.
次要结局
- Change From Baseline in the Area Under the Curve (AUC) From 0 to 180 Minutes for Postprandial Glucose (PPG) During a Mixed Meal Tolerance Test (MMTT) in a Subgroup(Baseline , Week 24)
- Absolute Change From Baseline to Week 24 in Fasting Plasma Glucose (FPG) mmol/L(Baseline , Week 24)
- Proportion of Patients Achieving a Therapeutic Glycemic Response(Baseline , Week 24)
- Absolute Change From Baseline to Week 24 in Fasting Plasma Glucose (FPG) mg/dL(Baseline , Week 24)