A 52-Week International, Multi-centre, Randomised, Parallel-group, Double-blind, Active-controlled, Phase III Study With a 156-Week Extension Period to Evaluate the Efficacy and Safety of Dapagliflozin in Combination With Metformin Compared With Sulphonylurea in Combination With Metformin in Adult Patients With Type 2 Diabetes Who Have Inadequate Glycaemic 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
- 1,217
- 试验地点
- 1
- 主要终点
- Adjusted Mean Change in HbA1c Levels
研究概览
简要总结
This study is being carried out to see if dapagliflozin as an addition to metformin is effective and safe in treating patients with type 2 diabetes when compared to glipizide (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
- 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
- •Type 2 Diabetes
- •Treated with oral anti-diabetic drug therapy therapy including Metformin for at least 8 weeks prior to enrolment
- •HbA1c >6.5% and </=10%
排除标准
- •Type 1 Diabetes
- •Insulin therapy within one year of enrolment
- •Renal (kidney) failure or dysfunction
研究组 & 干预措施
1
dapagliflozin plus metformin
干预措施: metformin hydrochloride (Drug)
1
dapagliflozin plus metformin
干预措施: dapagliflozin (Drug)
2
glipizide plus metformin
干预措施: glipizide (Drug)
2
glipizide plus metformin
干预措施: metformin hydrochloride (Drug)
结局指标
主要结局
Adjusted Mean Change in HbA1c Levels
时间窗: Baseline to Week 52
To assess the effect of dapagliflozin plus metformin compared to glipizide plus metformin on the absolute change from baseline in HbA1c level after 52 weeks double-blind treatment in patients with type 2 diabetes who have inadequate glycaemic control on 1500 mg/day or higher doses of metformin therapy alone.
次要结局
- Adjusted Mean Change in Body Weight(Baseline to Week 52)
- Proportion of Participants With Body Weight Reduction of at Least 5%(Baseline to Week 52)
- Proportion of Participants With at Least One Episode of Hypoglycemia(Baseline to Week 52)