NCT02583919已完成2 期
Double Blind, Randomized, Placebo-Controlled, Phase 2 Study to Evaluate the Safety, Tolerability and Efficacy of ISIS 449884 Administered Once Weekly for 26 Weeks in Patients With Type 2 Diabetes Being Treated With Metformin
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
- 79
- 试验地点
- 2
- 主要终点
- Change in HbA1C
研究概览
简要总结
The purpose of this study is to evaluate the efficacy, safety, and tolerability of ISIS-GCGRRx in combination with metformin versus placebo
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, age 18 to 75
- •BMI ≥ 25.0 kg/m2
- •HbA1c ≥ 8.0% and ≤ 10.5%
- •Type 2 Diabetes Mellitus and on stable dose of Metformin
- •Agree to conduct home-based (fasted) blood glucose testing as directed
排除标准
- •Clinically significant abnormalities in medical history of physical exam
- •Show evidence of uncorrected hypothyroidism or hyperthyroidism hormone results
- •History of solid organ transplant or renal dialysis
- •History of liver disease
- •History of greater than 3 episodes of severe hypoglycemia within 6 months of screening
- •Treatment with any other antidiabetic drug(s) other than metformin within 3 months of screening
- •History of diabetic ketoacidosis
- •Any other significant illness or condition that may interfere with the patient participating or completing the study
- •Inability or unwillingness to comply with protocol or study procedures
研究组 & 干预措施
ISIS-GCGRRx - Dose Level 1
Experimental
ISIS-GCGRRx - Dose Level 1
干预措施: ISIS-GCGRRx- Dose Level 1 (Drug)
ISIS-GCGRRx - Dose Level 2
Experimental
ISIS-GCGRRx - Dose Level 2
干预措施: ISIS-GCGRRx- Dose Level 2 (Drug)
Placebo
Placebo Comparator
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Change in HbA1C
时间窗: Week 27 and subsequent timepoints
Change from Baseline
次要结局
- Safety and Tolerability will be assessed by determining the incidence, severity, dose-relationship adverse-effects, and changes in laboratory evaluations within each dose cohort(50 weeks)
研究者
研究点 (2)
Loading locations...
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