NCT00855166已完成3 期
A 24-week,Multi-centre,Int.,Double-blind,Rand.,Parallel-group,Plac.-Controlled,Phase III Study With a 78-week Ext.Per. to Evaluate the Effect of Dapagliflozin in Combination With Metformin on Body Weight in Subjects With Type2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin Alone
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 182
- 试验地点
- 1
- 主要终点
- Adjusted Mean Change in Total Body Weight
研究概览
简要总结
This study is being carried out to see if dapagliflozin in addition to metformin decreases body weight and if so, how it compares 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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetes
- •Ongoing treatment with metformin on a stable dose of ≥1500 mg/day for at least 12 weeks prior to enrolment
- •Inadequate glycemic control, defined as HbA1c ≥6.5% and ≤8.5%
- •≥30 years for males
- •≥55 years for females
排除标准
- •Type 1 Diabetes
- •Body weight change >5% within 3 months prior to enrolment
- •Renal and liver impairment
研究组 & 干预措施
A
Experimental
Dapagliflozin 10 mg plus Metformin
干预措施: Sitagliptin (Drug)
A
Experimental
Dapagliflozin 10 mg plus Metformin
干预措施: Dapagliflozin (Drug)
A
Experimental
Dapagliflozin 10 mg plus Metformin
干预措施: Metformin (Drug)
B
Placebo Comparator
Placebo plus Metformin
干预措施: Metformin (Drug)
B
Placebo Comparator
Placebo plus Metformin
干预措施: Sitagliptin (Drug)
B
Placebo Comparator
Placebo plus Metformin
干预措施: Placebo (Drug)
结局指标
主要结局
Adjusted Mean Change in Total Body Weight
时间窗: Baseline to Week 24
To evaluate the effect of dapagliflozin 10 mg daily in combination with metformin compared to placebo in combination with metformin on total body weight after 24 weeks of oral administration of double-blind treatment.
次要结局
- Adjusted Mean Change in Body Fat Mass(Baseline to Week 24)
- Proportion of Participants With Body Weight Decrease ≥5%(Baseline to Week 24)
- Adjusted Mean Change in Waist Circumference(Baseline to Week 24)
研究者
研究点 (1)
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