NCT01647308终止2 期
A Randomized, Double Blind, Placebo-Controlled, Phase 2 Study to Investigate the Effects of ISIS 304801 Lowering of ISIS-APOCIIIRX on Triglyceride Levels and Insulin Sensitivity in Subjects With Type 2 Diabetes Mellitus
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Total apoC-III
研究概览
简要总结
The purpose of this study is to evaluate the effects of ISIS ISIS-APOCIIIRX on Triglyceride Levels and Insulin Sensitivity in Subjects with Type 2 Diabetes on stable treatment 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •BMI >/= 25 to </= 40 kg/m2
- •Type 2 Diabetes Mellitus and on a stable dose of metformin
- •Hypertriglyceridemia
排除标准
- •Significant abnormalities in medical history, clinical examination or clinical testing
- •Use of oral anti-diabetic medication other than metformin within 3 months prior to dosing
- •History of outpatient insulin use for more than 2 weeks in the last year
研究组 & 干预措施
ISIS-APOCIIIRX
Active Comparator
干预措施: ISIS-APOCIIIRX (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Total apoC-III
时间窗: 91 Days
The effect of treatment with ISIS ISIS-APOCIIIRX or Placebo on fasting total apoC-III levels.
次要结局
- Insulin Sensitivity(Day 92)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
2 期
Safety, Tolerability, and Pharmacokinetic Study of ISIS ApoC-III Rx in HypertriglyceridemiaHypertriglyceridemiaNCT01529424Ionis Pharmaceuticals, Inc.89
已完成
2 期
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ISIS-APO(a)Rx in Participants With High Lipoprotein(a)Elevated Lipoprotein(a)NCT02160899Ionis Pharmaceuticals, Inc.64
已完成
2 期
Measure Liver Fat Content After ISIS 301012 (Mipomersen) AdministrationLipid Metabolism, Inborn ErrorsHyperlipidemiasMetabolic DiseasesHypolipoproteinemiaHypolipoproteinemiasHypobetalipoproteinemiasMetabolism, Inborn ErrorsGenetic Diseases, InbornInfant, Newborn, DiseasesCongenital AbnormalitiesMetabolic DisorderDyslipidemiasLipid Metabolism DisordersHypercholesterolemiaNCT00362180Kastle Therapeutics, LLC38
已完成
不适用
Lipid-lowering Effects of an Astaxanthin Supplement in Volunteers With Mild DyslipidaemiaDyslipidemiasNCT02343497Ajinomoto Foods Europe SAS68
已完成
1 期
Safety Study of ISIS 325568 in Healthy VolunteersType 2 Diabetes MellitusNCT00519727Ionis Pharmaceuticals, Inc.60