A 52-week International, Multicenter, Randomized, Double-Blind, Active-Controlled, Parallel Group, Phase 3bTrial With a Blinded 104-week Long -Term Extension Period to Evaluate the Efficacy and Safety of Saxagliptin Co-administered With Dapagliflozin in Combination With Metformin Compared to Glimepiride in Combination With Metformin ≥1500 mg in Adult Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Therapy Alone
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 444
- 试验地点
- 1
- 主要终点
- Change From Baseline in Hemoglobin A1c (HbA1c) at Week 52
研究概览
简要总结
This clincial trial is evaluating if the co-administration of saxagliptin and dapagliflozin, in addition to metformin, results in better glycemic control, as measured by HbA1c, over a treatment period of 52 weeks, compared to the addition of glimepiride to metformin in subjects with Type 2 Diabetes Mellitus who have inadequate glycemic control on Metformin Alone. We will compare the change from baseline in HbA1c achieved with saxagliptin, in co-administration with dapagliflozin, added to current background therapy with metformin compared to glimepiride added to current background therapy with metformin ≥1500 mg at Week 52.
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 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must be willing and able to give signed and dated written informed consent
- •Patients with Type 2 diabetes mellitus (T2DM) with inadequate glycemic control
- •Subjects should have been taking the same daily dose of metformin ≥ 1500 mg
- •Fasting Plasma Glucose ≤ 270 mg/dL (≤15 mmol/L)
- •Males and females, aged ≥18 years old at time of screening visit
- •Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test
- •WOCBP and males must agree to follow instructions for method(s) of contraception for the duration of treatment with study drug
排除标准
- •Clinical diagnosis of type I diabetes
- •History of diabetic ketoacidosis
- •Cardiovascular/vascular diseases within 3 months of the enrollment
- •Renal disease
- •Hepatic diseases
- •History of, or currently, acute or chronic pancreatitis
- •Hematological and oncological disease/conditions
- •Patients who have contraindications to therapy being studied
- •Patients on weight loss program(s)
- •Replacement or chronic systemic corticosteroid therapy
研究组 & 干预措施
Saxagliptin 5 mg/ dapagliflozin 10mg or Placebo
Saxagliptin 5 mg /dapagliflozin 10 mg Placebo once a day orally
干预措施: Saxagliptin (Drug)
Saxagliptin 5 mg/ dapagliflozin 10mg or Placebo
Saxagliptin 5 mg /dapagliflozin 10 mg Placebo once a day orally
干预措施: Dapagliflozin (Drug)
Saxagliptin 5 mg/ dapagliflozin 10mg or Placebo
Saxagliptin 5 mg /dapagliflozin 10 mg Placebo once a day orally
干预措施: Placebo (Other)
Glimepiride or Placebo
Glimepiride or placebo 1mg or 2mg or 3mg or 4mg or 6mg once a day orally
干预措施: Glimepiride (Drug)
Glimepiride or Placebo
Glimepiride or placebo 1mg or 2mg or 3mg or 4mg or 6mg once a day orally
干预措施: Placebo (Other)
结局指标
主要结局
Change From Baseline in Hemoglobin A1c (HbA1c) at Week 52
时间窗: Baseline and Week 52
To examine whether the mean change from baseline in HbA1c with co-administered saxagliptin 5 mg and dapagliflozin 10 mg plus metformin is superior to titrated glimepiride plus metformin after 52 weeks of double-blind treatment.
次要结局
- Change From Baseline in Total Body Weight at Week 52(Baseline and Week 52)
- Percentage of Subjects Achieving a Therapeutic Glycemic Response, Defined as HbA1c < 7.0%, at Week 52(At Week 52)
- Change From Baseline in Systolic Blood Pressure (SBP) at Week 52(Baseline and Week 52)
- Percentage of Subjects With Treatment Intensification During the 52-week Short-term Treatment Period(Up to Week 52)
- Percentage of Subjects With Treatment Intensification During the 156-Week Short-term Plus Long-Term Treatment Period.(Up to Week 156)
- Percentage of Subjects Achieving a Therapeutic Glycemic Response, Defined as HbA1c < 7.0%, at Week 156(At Week 156)
- Time to Treatment Intensification During the 156-Week Short-term Plus Long-Term Treatment Period.(Up to Week 156)