NCT00330200终止2 期
A Randomized, Double-Blind, Placebo-Controlled Study to Examine the Effects of ISIS 113715 Monotherapy on Insulin Sensitivity, Glucose and Lipid Metabolism and Energy Expenditure in Subjects With Type 2 Diabetes Mellitus
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 2
- 主要终点
- Evaluate the effects on fasting and postprandial glucose excursions
研究概览
简要总结
The aim of this study is to examine the effects of ISIS 113715 monotherapy on insulin sensitivity, glucose and lipid metabolism and energy expenditure in subjects with type 2 diabetes mellitus.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female (post menopausal and/or surgically sterile)
- •Aged 18 to 70 years
- •Treatment naïve subjects with fasting blood glucose levels of 150-220 mg/dL, hematocrit of >/= 35% and HbA1c levels of >/= 7% and </= 10.0%
- •Subjects on antidiabetic therapy with fasting blood glucose levels of 100-200 mg/dL, hematocrit of >/= 35%, and HbA1c levels of >/= 6.5% and </= 9.0%
排除标准
- •Greater than 3 severe hypoglycemic episodes within six months of screen
- •Pregnant, breastfeeding, or intends to become pregnant
- •Clinical signs or symptoms of liver disease, acute or chronic hepatitis, or ALT greater than 1.5 times the upper limit of normal
- •History of hepatitis B surface antigen, hepatitis C antibody, or HIV
- •Complications of diabetes (e.g., neuropathy, nephropathy, and retinopathy)
- •Clinically significant and currently active diseases
- •Clinically significant abnormalities in medical history, physical examination, or laboratory examination
结局指标
主要结局
Evaluate the effects on fasting and postprandial glucose excursions
Evaluate the effects of ISIS 113715 on hepatic and peripheral insulin sensitivity
Evaluate the effects on hemoglobin A1c (HbA1c)
Examine the effect on whole body energy expenditure
次要结局
- Expand the safety and tolerability profile for ISIS 113715
- Assess the effects of ISIS 113715 on rates of basal and insulin stimulated whole body glycerol turnover
- Assess the effects of ISIS 113715 on insulin suppression of local rates of lipolysis (microdialysis)
研究者
研究点 (2)
Loading locations...
相似试验
Unknown
4 期
Intensive Insulin for Severe/Moderate Hypertriglyceridemia Pancreatitis.Acute PancreatitisHypertriglyceridemiaNCT03501680First Affiliated Hospital of Wenzhou Medical University200
已完成
不适用
Low Glycemic Index (GI) Diet Management for Pregnant Woman With OverweightOverweightPregnant WomenNCT01628835Children's Hospital of Fudan University400
已完成
不适用
Short-Term Intensive Insulin Therapy Induction of Long-term Glycemic ControlType 2 DiabetesNCT00506194Taipei Veterans General Hospital, Taiwan60
已完成
不适用
Comparison of the effects of insulin monotherapy and combination therapy with ipragliflozin and insulin on glucose toxicity in type 2 diabetes mellitus : a randomized controlled trialType 2 diabetesJPRN-UMIN000018784Osaka university medical hospital40
已完成
1 期
Safety, Tolerability, and Activity Study of ISIS SOD1Rx to Treat Familial Amyotrophic Lateral Sclerosis (ALS) Caused by SOD1 Gene MutationsFamilial Amyotrophic Lateral SclerosisNCT01041222Ionis Pharmaceuticals, Inc.33