NCT01505426已完成3 期
A Phase III, Double-Blind, Randomized, Placebo-Controlled Study to Assess the Efficacy and Safety of ASP1941 in Combination With Metformin in Asian Subjects With Type 2 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
- 入组人数
- 171
- 主要终点
- Change in HbA1c from baseline to end of treatment
研究概览
简要总结
To compare the efficacy and safety of ASP1941 + metformin with metformin alone in Asian subjects with type 2 diabetes mellitus.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed as type 2 diabetes mellitus patient at least 12 weeks before the study
- •Stable diet and exercise program for at least 8 weeks before the study
- •On a stable dose of at least 1500 mg/day metformin monotherapy or at least 1000 mg/day metformin monotherapy for the subject who can not titrate up to 1500 mg/day due to safety concern of metformin
- •BMI of 20.0 to 45.0 kg/m2
- •A HbA1c value between 7.0 and 10.0% at screening AND does not meet any of discontinuation criteria on fasting plasma glucose
排除标准
- •Type 1 diabetes mellitus
- •Proliferative diabetic retinopathy
- •Receiving insulin within 12 weeks prior to the study
- •History of clinically significant renal disease(s)
- •Significant dysuria caused by a neurogenic bladder or a benign prostate hypertrophy etc.
- •Urinary tract infection or genital infection
- •Continuous use of systemic corticosteroids, immunosuppressants, or loop diuretics
- •History of cerebrovascular attack, unstable angina, myocardial infarction, angioplasty, serious cardiac diseases within 12 weeks prior to the study
- •Severe infection, serious trauma, or perioperative subject
- •Known or suspected hypersensitivity to ASP1941
- •History of treatment with ASP1941
- •Participated in another clinical study, postmarketing study or medical device study within 12 weeks before the study
- •Serum creatinine value exceeding the upper limit of normal range
- •Urinary microalbumin/urinary creatinine ratio >300 mg/g
研究组 & 干预措施
ASP1941 group
Experimental
ASP1941 + metformin
干预措施: metformin (Drug)
ASP1941 group
Experimental
ASP1941 + metformin
干预措施: ASP1941 (Drug)
placebo group
Placebo Comparator
placebo + metformin
干预措施: metformin (Drug)
placebo group
Placebo Comparator
placebo + metformin
干预措施: Placebo (Drug)
结局指标
主要结局
Change in HbA1c from baseline to end of treatment
时间窗: Baseline and up to 24 weeks
次要结局
- Change in fasting plasma glucose level(Baseline and up to 24 weeks)
- Change in fasting serum insulin level(Baseline and up to 24 weeks)
- Change in waist circumference(Baseline and up to 24 weeks)
- Safety assessed by the incidence of adverse events, vital signs safety labo-tests and 12-lead ECG(For 24 weeks)
- Change in body weight(Baseline and up to 24 weeks)
研究者
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