A Double-blind, Placebo Controlled, Randomized Study to Evaluate the Safety and Tolerability of INCB019602 Plus Metformin Compared to Metformin Alone in Type 2 Diabetic Subjects
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 48
- 主要终点
- Safety and tolerability as determined by monitoring of AEs, vital signs, ECGs, physical examinations, and clinical laboratory blood and urine parameters.
研究概览
简要总结
Determine the effect of treatment with INCB019602 administered as an add-on to stable dose metformin therapy in type 2 diabetic subjects on safety 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
- 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
- •Established diagnosis of T2D
- •Currently taking metformin monotherapy at a stable dose level
- •FPG between 150 and 270 mg/dL
排除标准
- •History or clinical manifestations of renal impairment
- •Hyperglycemia > 270 mg/dL
- •Receiving thiazolidenediones, Exenatide or sulfonylureas within 90 days prior to screening
- •Prior use of Acipimox which is known under the name Olbetam within 90 days prior to screening.
- •Diagnosed major depression within the last 2 years requiring hospitalization
- •History of chronic insulin therapy for glycemic control
研究组 & 干预措施
Treatment A
5 mg of INCB019602 in AM with placebo administration in PM
干预措施: INCB019602 (Drug)
Treatment A
5 mg of INCB019602 in AM with placebo administration in PM
干预措施: Placebo (Drug)
Treatment A
5 mg of INCB019602 in AM with placebo administration in PM
干预措施: Metformin (Drug)
Treatment B
20 mg of INCB019602 in AM with placebo administration in PM
干预措施: INCB019602 (Drug)
Treatment B
20 mg of INCB019602 in AM with placebo administration in PM
干预措施: Placebo (Drug)
Treatment B
20 mg of INCB019602 in AM with placebo administration in PM
干预措施: Metformin (Drug)
Treatment C
5 mg of INCB019602 in PM with placebo administration in AM
干预措施: INCB019602 (Drug)
Treatment C
5 mg of INCB019602 in PM with placebo administration in AM
干预措施: Placebo (Drug)
Treatment C
5 mg of INCB019602 in PM with placebo administration in AM
干预措施: Metformin (Drug)
Treatment D
20 mg of INCB019602 in PM with placebo administration in AM
干预措施: INCB019602 (Drug)
Treatment D
20 mg of INCB019602 in PM with placebo administration in AM
干预措施: Placebo (Drug)
Treatment D
20 mg of INCB019602 in PM with placebo administration in AM
干预措施: Metformin (Drug)
Treatment E
7.5 mg of INCB019602 in PM QoD with placebo administration in AM as well as PM on non active dose days
干预措施: INCB019602 (Drug)
Treatment E
7.5 mg of INCB019602 in PM QoD with placebo administration in AM as well as PM on non active dose days
干预措施: Placebo (Drug)
Treatment E
7.5 mg of INCB019602 in PM QoD with placebo administration in AM as well as PM on non active dose days
干预措施: Metformin (Drug)
Treatment F
Placebo BID
干预措施: Placebo (Drug)
Treatment F
Placebo BID
干预措施: Metformin (Drug)
结局指标
主要结局
Safety and tolerability as determined by monitoring of AEs, vital signs, ECGs, physical examinations, and clinical laboratory blood and urine parameters.
时间窗: End of Study
次要结局
- Change from Baseline in fasting plasma glucose and population pharmacokinetics of INCB019602 in type 2 diabetic patients.(End of Study)