A Phase III, Double-Blind, Randomized, Active Controlled, Monotherapy Study to Assess the Efficacy and Safety of ASP1941 in Asian Subjects With Type 2 Diabetes Mellitus
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 46
- 主要终点
- Change in HbA1c from baseline to end of treatment
研究概览
简要总结
The purpose of this study is to assess the efficacy of ASP1941 based on the changes in HbA1C as well as its safety in Asian subjects with type 2 diabetes mellitus.
详细描述
This is a multi-center, active-controlled, double-blind, double-dummy, parallel-group comparative study. After a screening period followed by a placebo run-in period under the single-blind condition, subjects will be randomized to either the ASP1941 or the acarbose group. Subjects will take the study drug under the double-blind condition in the treatment period. After completion of the study drug administration, a follow-up period will be provided.
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 6 weeks before the study
- •for the hypoglycemic agent non-naïve subject, subject has been receiving a single hypoglycemic agent or low-dose of a dual combination therapy
- •BMI of 20.0 to 45.0 kg/m2
- •for the hypoglycemic agent non-naïve subject, subject has a HbA1c value between 6.8 and 10.0% at screening AND has a HbA1c value between 7.0 and 10.0%, inclusive, at run-in period
- •for the hypoglycemic agent naïve subject, subject has a HbA1c value between 7.0 and 10.0%, inclusive, at run-in period
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, acarbose or other alpha-GI
- •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
1941 group
Once daily over a 24-week treatment period
干预措施: ASP1941 (Drug)
1941 group
Once daily over a 24-week treatment period
干预措施: Placebo (Drug)
acarbose group
Once daily over a 24-week treatment period
干预措施: acarbose (Drug)
acarbose group
Once daily over a 24-week treatment period
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 serum insulin level(Baseline and up to 24 weeks)
- Change in body waist circumference(Baseline and up to 24 weeks)
- Change in fasting plasma glucose level(Baseline and up to 24 weeks)
- Change in body weight(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)