NCT01054092已完成3 期
Long-term Study of ASP1941 - A Phase III, Open-Label, Uncontrolled, Monotherapy Study to Assess the Long-term Safety, Tolerability and Efficacy of ASP1941 in Japanese Patients With Type 2 Diabetes Mellitus
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
- 182
- 主要终点
- HbA1c
研究概览
简要总结
The primary objective of this study is to evaluate the long-term safety of ASP1941 in patients with type 2 diabetes mellitus. The second objectives are to compare the efficacy and pharmacokinetics of ASP1941 administered before or after food intake.
详细描述
Subject will be randomized into either ASP1941 before meal or ASP1941 after meal groups. Subjects will undergo a screening period before entering the long-term treatment. Dosage may be increased during the treatment period if subjects fulfill increasing criteria and the investigators adjudicate that no impact for subjects safety.
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
- None
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
- •Type 2 diabetic patients for at least 12 weeks
- •HbA1c value between 6.5 and 9.5%
- •Body Mass Index ( BMI )20.0 - 45.0kg/m2
排除标准
- •Type 1 diabetes mellitus patients
- •Serum creatinine > upper limit of normal
- •Proteinuria (albumin/creatinine ratio > 300mg/g)
- •Dysuria and/or urinary tract infection, genital infection
- •Significant renal, hepatic or cardiovascular diseases
- •Severe gastrointestinal diseases
- •Proliferative diabetic retinopathy
研究组 & 干预措施
after meal group
Experimental
ASP1941 will be administered after meal
干预措施: ipragliflozin (Drug)
before meal group
Experimental
ASP1941 will be administered before meal
干预措施: ipragliflozin (Drug)
结局指标
主要结局
HbA1c
时间窗: For 52 weeks
次要结局
- Fasting plasma glucose(For 52 weeks)
- Fasting serum insulin(For 52 weeks)
- Plasma levels of ASP1941 for population PK analysis(For 52 weeks)
- Safety assessed by adverse events, vital signs laboratory tests and 12-lead ECGs(For 52 weeks)
研究者
相似试验
已完成
3 期
A Study to Assess the Safety and Efficacy of ASP1941 in Combination With α-glucosidase Inhibitor in Type 2 Diabetic PatientsType 2 Diabetes MellitusNCT01242202Astellas Pharma Inc113
已完成
3 期
A Study to Assess Safety and Efficacy of ASP1941 in Combination With Nateglinide in Type 2 Diabetic PatientsType 2 Diabetes MellitusNCT01316107Astellas Pharma Inc122
已完成
3 期
A Study to Assess the Safety and Efficacy of ASP1941 in Combination With Dipeptidyl Peptidase-4 (DPP-4) Inhibitor in Type 2 Diabetic PatientsType 2 Diabetes MellitusNCT01242228Astellas Pharma Inc106
已完成
3 期
A Study to Assess the Efficacy and Safety of ASP1941 in Combination With Sulfonylurea in Type 2 Diabetic PatientsType 2 Diabetes MellitusNCT01242215Astellas Pharma Inc243
招募中
3 期
A Study of Apremilast in Children With Oral Ulcers Associated With Behçet's Disease or Juvenile Psoriatic ArthritisBehçet's DiseaseJuvenile Psoriatic ArthritisNCT05767047Amgen48