NCT02824003已完成2 期
Double Blind, Randomized, Placebo-Controlled, Phase 2A Mechanistic Study to Evaluate the Effect of ISIS 449884 (ISIS-GCGRRx) on Hepatic Lipid and Glycogen Content 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
- 15
- 试验地点
- 1
- 主要终点
- Change in fasting hepatic lipid content
研究概览
简要总结
The purpose of this study is to evaluate the effect of ISIS 449884 (ISIS-GCGRRX) on Hepatic Lipid and Glycogen Content in patients with Type 2 Diabetes being treated with 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
- 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 < 36.0 kg/m2
- •HbA1c ≥ 7.5% and ≤ 10.5%
- •Type 2 Diabetes Mellitus and on stable dose of Metformin. Patients must have been on a stable dose of oral metformin (at least 1000 mg/day) for a minimum of 3 months prior to screening evaluation and will be required to continue their stable dose of metformin throughout the study. Patients on a stable dose of metformin plus a sulfonylurea (SU) or metformin plus a dipeptidyl peptidase-IV (DPPIV) inhibitor for a minimum of 3 months prior to Screening evaluation may be allowed
- •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
- •History of liver transplantation 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, SU or DPPIV 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
Experimental
ISIS-GCGRRx once weekly dosing for 13 weeks
干预措施: ISIS-GCGRRx (Drug)
Placebo
Placebo Comparator
once weekly dosing for 13 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Change in fasting hepatic lipid content
时间窗: Week 14
Change from Baseline
Change in fasting hepatic glycogen content
时间窗: Week 14
Change from Baseline
次要结局
- Safety and Tolerability will be assessed by determining the incidence, severity, dose relationship of adverse effects, and changes in laboratory evaluations(38 weeks)
研究者
研究点 (1)
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