NCT00997152终止2 期
A Phase II, Randomized, Double-Blind, Placebo-controlled, Multi-Center, Parallel Group Study Evaluating the Efficacy, Safety and Pharmacokinetics of JTT-654 Administered for 12 Weeks in Untreated or Metformin-treated Type 2 Diabetic Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 152
- 主要终点
- Change in Fasting Plasma Glucose (FPG) levels
研究概览
简要总结
The purpose of this study is to evaluate the effect of JTT-654 on diabetes as well as the safety, tolerability and pharmacokinetics of JTT-654 in type 2 diabetic patients.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have type 2 diabetes;
- •Body mass index (BMI) of ≤ 45.0 kg/m2;
- •Are either untreated with respect to hypoglycemic agents OR are currently being treated with a stable dose of metformin alone.
排除标准
- •Females who are pregnant or breast-feeding;
- •Known medical history or presence of type 1 diabetes or pancreatitis, acute metabolic diabetic complications, presence of unstable or rapidly progressing retinopathy, nephropathy or neuropathy;
- •Acute coronary syndrome or uncontrolled hypertension;
- •Does not meet all diet or previous/concomitant medication restrictions criteria, as described in the protocol.
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: JTT-654 Placebo (Drug)
Dose 2 JTT-654
Experimental
干预措施: JTT-654 (Drug)
Dose 1 JTT-654
Experimental
干预措施: JTT-654 (Drug)
结局指标
主要结局
Change in Fasting Plasma Glucose (FPG) levels
时间窗: 3 months
次要结局
- Change in glycosylated hemoglobin (HbA1c) levels(3 months)
- Effect on glycated albumin, insulin, C-peptide, glucagon and lipid parameters(3 months)
- Safety (biochemistry, hematology, urinalysis and adrenal-related markers) and tolerability (adverse events)(3 months)
研究者
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