NCT01071850已完成2 期
A Phase 2, Double-Blind, Randomized, Placebo and Active-Controlled Dose-Finding Study to Assess the Efficacy, Safety and Tolerability of Multiple Oral Doses of ASP1941 in Patients With Type 2 Diabetes Mellitus
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 412
- 试验地点
- 59
- 主要终点
- Mean change from baseline in Hemoglobin A1c (HbA1c)
研究概览
简要总结
Evaluate the efficacy, safety, and tolerability of multiple doses of ASP1941 compared to placebo over 12 weeks of therapy in adult patients 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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject has been diagnosed with type 2 diabetes
- •Subject has a HbA1c value between 6.8 and 9.5%
- •Subject has never, is not currently taking anti-diabetic medication OR is receiving a single anti- diabetic agent or low-doses two anti-diabetic medications and is willing to discontinue them during the study
- •Subject is on a stable diet and exercise program
- •Female subject is not pregnant and agrees to use an acceptable form of contraception throughout the duration of the study
排除标准
- •Subject has type 1 diabetes mellitus
- •Subject is using insulin therapy
- •Subject has a serum creatinine higher than upper limit of normal
- •Subject has an ALT and/or AST value higher than 3 times upper limit of normal or a total bilirubin value more than 2 times upper limit of normal
- •Subject has persistent, uncontrolled severe hypertension as indicated by a
- •systolic blood pressure >180 mmHg or a diastolic blood pressure of
- •Subject has had significant cardiovascular disease such as myocardial infarction or a vascular intervention (e.g., angioplasty or stent) in the last 3 months
- •Subject is known to have hepatitis or be a carrier of hepatitis B surface
- •antigen, hepatitis C virus antibody or is known positive for HIV1 and/or
- •Subject has a history of lactic acidosis
- •Subject has a history of drug and alcohol abuse/dependency within last 12
- •Subject has had a malignancy in the last 5 years, except for successfully
- •treated basal or squamous cell carcinoma of the skin or of the cervix
- •Subject has a symptomatic urinary tract infection or genital infection
- •Female subject is lactating
- •Subject has an unstable medical or psychiatric illness
研究组 & 干预措施
ASP1941 highest dose
Experimental
oral tablet
干预措施: ipragliflozin (Drug)
Metformin
Active Comparator
oral tablet
干预措施: Metformin (Drug)
Placebo
Placebo Comparator
oral tablet
干预措施: Placebo (Drug)
ASP1941 lowest dose
Experimental
oral tablet
干预措施: ipragliflozin (Drug)
ASP1941 low dose
Experimental
oral tablet
干预措施: ipragliflozin (Drug)
ASP1941 high dose
Experimental
oral tablet
干预措施: ipragliflozin (Drug)
结局指标
主要结局
Mean change from baseline in Hemoglobin A1c (HbA1c)
时间窗: 12 weeks
次要结局
- Proportion of subjects achieving target goal of HbA1c <7.0%(12 weeks)
- Proportion of subjects achieving target goal of HbA1c <6.5%(12 weeks)
- Mean change from baseline in fasting plasma glucose (FPG)(12 weeks)
研究者
研究点 (59)
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