A Phase II, Randomized, Double-Blind, Placebo-and Active-Controlled, Multi-center Study to Determine the Efficacy and Safety of TAK-379 in Subjects With Type 2 Diabetes
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 323
- 主要终点
- Change from Baseline in Glycosylated Hemoglobin
研究概览
简要总结
The purpose of this study is to evaluate the safety and effectiveness of multiple doses of TAK-379, once daily (QD), in subjects with type 2 diabetes mellitus.
详细描述
Type 2 diabetes is a metabolic disease that has reached epidemic proportions. The global incidence of this disease is estimated to increase from 120 million individuals to over 200 million by the year 2010. In type 2 diabetes, multiple metabolic defects contribute to hyperglycemia. These include insulin resistance, inadequate insulin secretion, and excessive hepatic glucose production. Nine classes of antihyperglycemic agents are currently approved for the treatment of type 2 diabetes (insulin, sulfonylureas, biguanides, alpha-glycosidase inhibitors, thiazolidinediones, glinides, glucagon-like peptide analogues, amylin analogues, and dipeptidyl peptidase 4 inhibitors). Each class acts by a unique mechanism on 1 or more of the metabolic defects.
Takeda Pharmaceutical Company Limited is developing TAK-379, a non-thiazolidinedione partial proliferator-activated receptor agonist for the treatment of type 2 diabetes mellitus. Study participation is anticipated to be approximately 4.5 months.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
TAK-379 200 mg QD
干预措施: TAK-379 (Drug)
TAK-379 25 mg QD
干预措施: TAK-379 (Drug)
TAK-379 100 mg QD
干预措施: TAK-379 (Drug)
Pioglitazone 30 mg QD
干预措施: Pioglitazone (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Change from Baseline in Glycosylated Hemoglobin
时间窗: Week 12 or Final Visit
次要结局
- Number of patients with elevation of alanine aminotransferase greater than three times the Upper Limit of Normal during treatment.(Week 12 or Final Visit)
- Change from baseline in glycosylated hemoglobin.(Weeks 4 and 8 or Final Visit)
- Change from baseline in fasting plasma glucose.(Weeks 1, 2, 4, 8 and 12 or Final Visit)
- Change from baseline in body weight.(Weeks 4, 8 and 12 or Final Visit)
- Plasma concentrations of TAK-379 and its metabolite M-I via a sparse sampling population approach.(Week 12 or Final Visit)