NCT00929539已完成2 期
A Phase II, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy, Safety and Tolerability of JTT-130 in Treatment-naïve, Metformin Only or Metformin Plus Sulfonylurea-treated Obese 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
- 已完成
- 入组人数
- 496
- 主要终点
- Change in glycosylated hemoglobin (HbA1c) levels
研究概览
简要总结
The purpose of this study is to evaluate the effect of JTT-130 on diabetes as well as the safety and tolerability of JTT-130 in obese 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 > 27.0 kg/m2 and ≤ 45.0 kg/m2;
- •Are either drug naïve with respect to hypoglycemic agents OR are currently being treated with metformin alone or in combination with a sulfonylurea. Metformin and sulfonylurea dosing must be stable.
排除标准
- •Females who are pregnant or breast-feeding
- •Known medical history or presence of type 1 diabetes, pancreatitis, unstable or rapidly progressing retinopathy, nephropathy or neuropathy;
- •Acute coronary syndrome or uncontrolled hypertension;
- •Does not meet medication restriction criteria, as described in the protocol.
研究组 & 干预措施
Dose 1 JTT-130
Experimental
干预措施: JTT-130 (Drug)
Dose 2 JTT-130
Experimental
干预措施: JTT-130 (Drug)
Dose 3 JTT-130
Experimental
干预措施: JTT-130 (Drug)
Placebo
Placebo Comparator
干预措施: JTT-130 Placebo (Drug)
结局指标
主要结局
Change in glycosylated hemoglobin (HbA1c) levels
时间窗: End of Study
次要结局
- Safety and tolerability data(End of Study)
研究者
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