NCT00330330已完成2 期
A Double-Blind, Placebo-Controlled, Dose-Escalation Study to Assess the Safety, Tolerability, Pharmacokinetics, and Activity of ISIS 113715 in Patients With Type 2 Diabetes Mellitus Who Have Not Received Prior Therapy
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 96
- 试验地点
- 20
- 主要终点
- To evaluate the pharmacokinetic profile of ISIS 113715
研究概览
简要总结
The aim of this study is to evaluate the safety, tolerability, and pharmacokinetics of five ISIS 113715 intravenous dose cohorts in drug-naïve type 2 diabetics.
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
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
- •Type 2 Diabetes Mellitus of less than 5 years in duration
- •Have never received hypoglycemic therapy
- •Aged 18 to 65 years
- •Fasting blood glucose between 130 and 220 mg/dL (7.2 to 12.2 mmol/L) for Cohorts A-D and between 140 and 220 mg/dL (7.8 to 12.2 mmol/L) for Cohort E
- •HbA1c between 6.8 and 10.0% for Cohorts A-D and between 7.5 and 11.0% for Cohort E
- •Body Mass index > 25 and < 35 kg m -2
排除标准
- •Medication that may affect glucose homeostasis (e.g. systemic glucocorticoid) within one month of screening
- •Clinically significant abnormalities in medical history or physical exam
- •Clinically significant abnormalities on laboratory examination
- •History of HIV infection
- •Active infection requiring antiviral or antimicrobial therapy
- •Malignancy (with the exception of basal or squamous cell carcinoma of the skin if adequately treated and no recurrence for > one year at the time of screening)
- •Any other concurrent condition which, in the opinion of the Investigator, would preclude participation in or interfere with compliance
- •Alcohol or drug abuse
- •Undergoing or have undergone treatment with another investigational drug, biologic agent or device within 90 days of screening
- •Abnormal serum creatinine concentration defined as > 1.5 mg/dL (132.6 micro mol/L) for males and > 1.2 mg/dL (106 micro mol/L) for females
- •Medications that may affect coagulation (heparin, warfarin, etc.) with the exception of acetylsalicylic acid or non-steroidal anti-inflammatory agents.
- •Allergy to sulfur-containing medications
结局指标
主要结局
To evaluate the pharmacokinetic profile of ISIS 113715
To evaluate the safety and tolerability of ISIS 113715
To evaluate the pharmacologic activity of ISIS 113715
次要结局
未报告次要终点
研究者
研究点 (20)
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