NCT00478322已完成2 期
Pharmacodynamic Study of the Effect of INCB013739 on Insulin Sensitivity in Obese, Type 2 Diabetic Subjects
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
- 24
- 主要终点
- Changes in lipid profile laboratory values
研究概览
简要总结
Purpose: A 28-day US study in patients with type 2 diabetes mellitus to assess the safety and tolerability as well as the effects of treatment with an investigational drug.
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
- Double (Participant, Investigator)
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 an established diagnosis of Type 2 Diabetes as determined by the investigator.
- •Females will be postmenopausal for at least 1 year with documented FSH > 30 IU/L.
排除标准
- •Hypertriglyceridemia > 500 mg/dL at screening.
- •BMI > 40 kg/m
- •Receiving thiazolidinediones, insulin, or exenatide within the 3 months prior to screening.
- •History or clinical manifestations of Addison's disease, Cushing's Syndrome, or other disorders involving glucocorticoids or mineralocorticoids.
- •Current treatment or treatment within 30 days or five half-lives (whichever is longer) prior to the first dose of study medication with another investigational medication or current enrollment in another investigational protocol.
研究组 & 干预措施
INCB013739
Experimental
干预措施: INCB013739 (Drug)
Matching Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Changes in lipid profile laboratory values
时间窗: Measured at baseline and weekly for four weeks
Assessment of pharmacodynamics of INCB013739 through analysis of blood samples
时间窗: Measured at baseline and weekly for four weeks
Assessment of ECGs, physical examinations and laboratory values for adverse events
时间窗: Measured at baseline through study completion
Assessment of pharmacokinetics of INCB013739 through analysis of blood samples.
时间窗: Measured at baseline and weekly for four weeks
次要结局
未报告次要终点
研究者
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