Randomized Study to Evaluate the Safety and Efficacy of INCB013739 Plus Metformin Compared to Metformin Alone on Glycemic Control in Type 2 Diabetic Subjects
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 302
- 主要终点
- Change from Baseline to Week 12 in hemoglobin A1c (HbA1c)
研究概览
简要总结
Determine the effect of treatment with INCB013739 administered as an 'add-on' to metformin therapy in type 2 diabetic subjects on safety and tolerability and glycemic control.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Established diagnosis of Type 2 Diabetes
- •Stable dose of metformin for more than 8 weeks
排除标准
- •Subjects with Addison's disease or Cushing's Syndrome
- •Type 1 diabetes mellitus or secondary forms of diabetes
- •Subjects with uncontrolled thyroid disease
- •History of renal impairment
研究组 & 干预措施
Treatment C - INCB013739 & Metformin
INCB013739 50 mg QD and Metformin
干预措施: Metformin (Drug)
Treatment A - INCB013739 & Metformin
INCB013739 5 mg QD and Metformin
干预措施: INCB013739 (Drug)
Treatment A - INCB013739 & Metformin
INCB013739 5 mg QD and Metformin
干预措施: Metformin (Drug)
Treatment B - INCB013739 & Metformin
INCB013739 15 mg QD and Metformin
干预措施: INCB013739 (Drug)
Treatment B - INCB013739 & Metformin
INCB013739 15 mg QD and Metformin
干预措施: Metformin (Drug)
Treatment C - INCB013739 & Metformin
INCB013739 50 mg QD and Metformin
干预措施: INCB013739 (Drug)
Treatment D - INCB013739 & Metformin
INCB013739 100 mg QD and Metformin
干预措施: INCB013739 (Drug)
Treatment D - INCB013739 & Metformin
INCB013739 100 mg QD and Metformin
干预措施: Metformin (Drug)
Treatment E - INCB013739 & Metformin
INCB013739 200 mg QD and Metformin
干预措施: INCB013739 (Drug)
Treatment E - INCB013739 & Metformin
INCB013739 200 mg QD and Metformin
干预措施: Metformin (Drug)
Treatment F - Placebo
Matching placebo
干预措施: Placebo comparator matching INCB013739 (Drug)
结局指标
主要结局
Change from Baseline to Week 12 in hemoglobin A1c (HbA1c)
时间窗: Baseline and Week 12 (or early termination study visit)
次要结局
- Change from Baseline to Week 12 in fasting plasma glucose (FPG).(Baseline and Week 12 (or early termination study visit))