A 24-week International, Multicenter, Randomized, Open-Label, Active-Controlled, Parallel Group, Phase 3b Trial With a 28-week Extension to Evaluate the Efficacy and Safety of Saxagliptin Co-administered With Dapagliflozin Compared to Insulin Glargine in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin With or Without Sulfonylurea Therapy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 650
- 试验地点
- 1
- 主要终点
- Mean Change From Baseline in HbA1c at Week 24
研究概览
简要总结
This research study of subjects with inadequately controlled type 2 diabetes mellitus (T2DM) will compare the glycemic control (measured by HbA1c) in subjects co-administered saxagliptin and dapagliflozin, in addition to metformin with or without sulfonylurea, to subjects receiving insulin glargine, in addition to metformin with or without sulfonylurea, over a treatment period of 52 weeks.
详细描述
CV181-369; A 24 Week International, Open-Label Trial With a 28 Week Extension to Evaluate the Efficacy of Saxagliptin Co-administered With Dapagliflozin Compared to Insulin Glargine in Subjects With Type 2 Diabetes on Metformin With or Without Sulfonylurea Therapy
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
- None
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least 18 years of age at screening
- •HbA1c ≥ 8% and ≤ 12% at screening
- •Fasting plasma glucose (FPG) ≤ 270 mg/dL (15mmol/L)
- •Stable dose metformin ≥ 1500 mg per day with or without a stable dose of sulfonylurea (defined as at least 50% maximal dose per local label) for at least 8 weeks
- •estimated glomerular filtration rate (eGFR) < 60 ml/ml/1.73m2
- •Body Mass Index ≤ 45.0 kg/m2
排除标准
- •Clinical diagnosis of Type 1 diabetes
- •History of ketoacidosis
- •Renal, hepatic or pancreatic disease
- •Impairment of renal function (defined as creatinine clearance [CrCl] < 60 mL/min
- •Cardiovascular or vascular diseases identified within 3 months of participationImpairment of renal function (defined as creatinine clearance [CrCl] < 60 mL/min
研究组 & 干预措施
Saxagliptin/Dapagliflozin/Metformin
Oral route. Saxagliptin/Dapa adminsitered once daily for 24 weeks at a dose of 5 mg Saxagliptin and 10 mg Dapagliflozin
干预措施: Saxagliptin, Onglyza (Drug)
Saxagliptin/Dapagliflozin/Metformin
Oral route. Saxagliptin/Dapa adminsitered once daily for 24 weeks at a dose of 5 mg Saxagliptin and 10 mg Dapagliflozin
干预措施: Dapagliflozin, Farxiga (Drug)
Saxagliptin/Dapagliflozin/Metformin
Oral route. Saxagliptin/Dapa adminsitered once daily for 24 weeks at a dose of 5 mg Saxagliptin and 10 mg Dapagliflozin
干预措施: Metformin (Drug)
Insulin Glargine, Lantos/Metformin
Insulin glargine administered once a day with starting dose of 0.2 Unit per kg or 10 units.
干预措施: Glargine insulin (Drug)
结局指标
主要结局
Mean Change From Baseline in HbA1c at Week 24
时间窗: Baseline and Week 24
To examine whether the mean change from baseline in HbA1c with co-administered saxagliptin 5 mg and dapagliflozin 10 mg plus metformin with or without SU is noninferior (noninferiority margin of 0.3%) to titrated insulin glargine plus metformin with or without SU after 24 weeks of open-label treatment.
次要结局
- Mean Change From Baseline in Total Body Weight at Week 24(Baseline and Week 24)
- Percentage of Subjects With Confirmed Hypoglycaemia at Week 24(Baseline and Week 24)
- Percentage of Subjects Achieving a Therapeutic Glycemic Response, Without Hypoglycaemia, at Week 24(Baseline and Week 24)
- Percentage of Subjects Achieving a Therapeutic Glycemic Response at Week 24(Baseline and Week 24)
- Change From Baseline in the Mean Value of 24-hour Glucose at Week 2(Baseline and Week 2)