NCT01885260已完成2 期
A Double Blind, Placebo-Controlled, Phase 2 Study to Assess the Safety, Tolerability and Efficacy of ISIS 449884 Administered Once Weekly to Patients With Type 2 Diabetes Mellitus 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
- 77
- 试验地点
- 1
- 主要终点
- The effect of ISIS-GCGRRx on serum fructosamine
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 + metformin
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
- •Male or female, age 18 to 75
- •BMI greater than or equal to 25
- •HbA1c greater than or equal to 7.5% and less than or equal to 10.5%
- •Type 2 Diabetes Mellitus and on stable dose of oral metformin
- •Agree to conduct home-based (fasted) blood glucose testing as directed
排除标准
- •Clinically significant abnormalities in medical history or physical exam
- •Show evidence of uncorrected hypothyroidism or hyperthyroidism hormone results
- •History of renal transplantation or renal dialysis
- •History of liver disease
- •History of greater than 3 episodes of severe hypoglycemia within 6 months of screening
- •Use of oral anti-diabetic medication 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
The effect of ISIS-GCGRRx on serum fructosamine
时间窗: 14 Weeks
Change from Baseline to Week 14
次要结局
- The safety of ISIS-GCGRRx(25 Weeks)
- The tolerability of ISIS-GCGRRx(25 Weeks)
研究者
研究点 (1)
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