A 52-Week, Multi-Centre, Randomised, Parallel-Group, Double-Blind, Active Controlled, Phase IV Study to Evaluate the Safety and Efficacy of Dapagliflozin or Dapagliflozin Plus Saxagliptin Compared With Sulphonylurea All Given as Add-on Therapy to Metformin in Adult Patients With Type 2 Diabetes Who Have Inadequate Glycaemic Control on Metformin Monotherapy
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 939
- 试验地点
- 1
- 主要终点
- Change in Haemoglobin A1c (HbA1c) From Baseline to Week 52
研究概览
简要总结
This study is being carried out to see if dapagliflozin and dapagliflozin plus saxagliptin as an addition to metformin is effective and safe in treating patients with type 2 diabetes when compared to glimepiride (sulphonylurea) as an addition to metformin treatment.
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 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Main Inclusion Criteria:
- •Is male or female and ≥18 and <75 years old at time of informed consent.
- •Has a HbA1c of ≥7.5% and ≤10.5% based on central laboratory results from Visit 1, with individual need for therapy escalation.
- •Currently treated with a stable maximum tolarated dose (MTD) (≥1500 mg/day) of metformin therapy for at least 8 weeks prior to Enrolment visit.
- •Has a BMI of ≤45 kg/m2 at Enrolment visit.
- •Has a C-peptide laboratory value of ≥1.0 ng/mL (0.33 nmol/L; 333.3 pmol/L) based on central laboratory results from Visit
排除标准
- •Clinically diagnosed with Type I diabetes, known diagnosis of maturity onset diabetes of the young (MODY), or secondary diabetes mellitus or known presence of glutamate decarboxylase 65 (GAD65) antibodies.
- •Patients who, in the judgment of the Investigator, may be at risk for dehydration or volume depletion that may affect the patient's safety and/or the interpretation of efficacy or safety data.
- •Clinically significant cardiovascular disease or procedure within 3 months prior to Enrolment or expected to require coronary revascularization procedure during the course of the study.
- •Concomitant treatment with loop diuretics
研究组 & 干预措施
Dapagliflozin+metformin
Dapagliflozin + saxagliptin placebo + glimepiride placebo + metformin
干预措施: Dapagliflozin (Drug)
Dapagliflozin+metformin
Dapagliflozin + saxagliptin placebo + glimepiride placebo + metformin
干预措施: Placebo for saxagliptin (Drug)
Dapagliflozin+metformin
Dapagliflozin + saxagliptin placebo + glimepiride placebo + metformin
干预措施: Placebo for glimepiride (Drug)
Dapagliflozin+saxagliptin+metformin
Dapagliflozin + saxagliptin + glimepiride placebo+ metformin
干预措施: Dapagliflozin (Drug)
Dapagliflozin+saxagliptin+metformin
Dapagliflozin + saxagliptin + glimepiride placebo+ metformin
干预措施: Saxagliptin (Drug)
Dapagliflozin+saxagliptin+metformin
Dapagliflozin + saxagliptin + glimepiride placebo+ metformin
干预措施: Placebo for glimepiride (Drug)
Glimepiride+metformin
Glimepiride + dapagliflozin placebo + saxagliptin placebo + metformin
干预措施: Glimepiride (Drug)
Glimepiride+metformin
Glimepiride + dapagliflozin placebo + saxagliptin placebo + metformin
干预措施: Placebo for dapagliflozin (Drug)
Glimepiride+metformin
Glimepiride + dapagliflozin placebo + saxagliptin placebo + metformin
干预措施: Placebo for saxagliptin (Drug)
结局指标
主要结局
Change in Haemoglobin A1c (HbA1c) From Baseline to Week 52
时间窗: Baseline, week 52. Values recorded after rescue treatment or collected more than 8 days after the last dose date were excluded from the analysis
Change in HbA1c from baseline (week 0) to week 52.
次要结局
- Patients With at Least One Episode of Confirmed Hypoglycaemia(Up to Week 52. Values recorded after rescue treatment or collected more than 8 days after the last dose date were excluded from the analysis)
- Change in Fasting Plasma Glucose (FPG) From Baseline to Week 52(Baseline, week 52. Values recorded after rescue treatment or collected more than 8 days after the last dose date were excluded from the analysis)
- Time to Rescue(Over the 52 week treatment period)
- Change in Total Body Weight From Baseline at Week 52(Baseline, week 52. Values recorded after rescue treatment or collected more than 8 days after the last dose date were excluded from the analysis)
- Number of Patients Rescued(Over the 52 week treatment period)