A 16-week, Multicentre, Randomised, Double-Blind, Placebo-Controlled Phase III Study to Evaluate the Safety and Efficacy of Dapagliflozin 2.5 mg BID, 5 mg BID and 10 mg QD Versus Placebo in Patients With Type 2 Diabetes Who Are Inadequately Controlled on Metformin-IR Monotherapy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 400
- 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 - administered in a daily dose of 2.5 mg given twice a day or 5 mg twice a day or 10mg once daily - in addition to metformin, is beneficial in diabetes treatment, and if so, how it compares to treatment with metformin alone.
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 77 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provision of informed consent prior to any study specific procedures
- •Diagnosis of T2DM
- •Current antihyperglycaemic treatment with metformin immediate release formulation monotherapy >/= 1500 mg/day at a stable dose for at least 10 weeks prior to enrolment. Other treatment with OADs within the 10 weeks prior to enrolment is not permitted.
- •HbA1c ≥ 6.7% and ≤10.5%, based on central laboratory values from Screening Visit, and Enrolment Visit 1.
排除标准
- •Diagnosis of Type 1 diabetes mellitus, known diagnosis of Maturity Onset Diabetes of the Young (MODY) or secondary causes of diabetes mellitus
- •History of diabetic ketoacidosis
- •Symptoms of poorly controlled diabetes including, but not limited to, marked polyuria, polydipsia, and/or greater than 10% weight loss during the 3 months prior to enrolment
- •FPG >270 mg/dL (>15.0 mmol/L)
- •BMI >45 kg/m2
研究组 & 干预措施
1
Dapagliflozin 2.5 mg twice-daily plus open-label metformin
干预措施: dapagliflozin (Drug)
1
Dapagliflozin 2.5 mg twice-daily plus open-label metformin
干预措施: metformin (Drug)
2
Dapagliflozin 5.0 mg twice-daily plus open-label metformin
干预措施: dapagliflozin (Drug)
2
Dapagliflozin 5.0 mg twice-daily plus open-label metformin
干预措施: metformin (Drug)
3
Dapagliflozin 10 mg once-daily plus open-label metformin
干预措施: dapagliflozin (Drug)
3
Dapagliflozin 10 mg once-daily plus open-label metformin
干预措施: metformin (Drug)
4
Placebo plus open-label metformin
干预措施: metformin (Drug)
4
Placebo plus open-label metformin
干预措施: placebo (Drug)
结局指标
主要结局
Adjusted Mean Change in HbA1c Levels
时间窗: Baseline to Week 16
To compare the change from baseline in HbA1c achieved with each of the 2 BID doses of dapagliflozin (2.5 mg BID and 5 mg BID) co-administered with metformin versus placebo co-administered with metformin after 16 weeks of double-blind treatment.
次要结局
- Adjusted Mean Change in Fasting Plasma Glucose (FPG) From Baseline to Week 16(Baseline to Week 16)
- Adjusted Percent Change in Body Weight(Baseline to Week 16)
- Adjusted Mean Change in Fasting Plasma Glucose (FPG) From Baseline to Week 1(Baseline to Week 1)
- Proportion of Participants With HbA1c<7.0% at Week 16, in Participants Who Had HbA1c ≥7.0% at Baseline.(Baseline to Week 16)