NCT01918865已完成2 期
A Double Blind, Placebo-Controlled, Phase 2 Study to Assess the Safety, Tolerability, and Efficacy of ISIS 404173 Administered Once Weekly to Obese Patients With Type 2 Diabetes Mellitus Being Treated With Metformin or Metformin Plus Sulfonylurea
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
- 92
- 试验地点
- 2
- 主要终点
- Incidence, severity, dose-relationship of adverse effects, and changes in laboratory evaluations as a measure of safety
研究概览
简要总结
The purpose of this study is to evaluate the safety, tolerability, and efficacy of ISIS-PTP1BRx + oral antidiabetic drug/s (metformin and/or sulfonylurea) versus placebo + oral antidiabetic drug/s.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Body mass index (BMI) >/= 27 kg/m2
- •HbA1c between 7.5% and 10.5% (inclusive)
- •C-Peptide (fasting) greater than or equal to 500 pmol/L
- •On stable dose of metformin alone or in combination with a stable dose of sulfonylurea for >/= 3 months prior to screening, and remain on stable dose throughout the study
- •Agree to conduct home-based (fasted) blood glucose testing as directed
排除标准
- •Clinically significant abnormalities in medical history or physical exam
- •Serum creatinine > ULN at Screening
- •Clinical signs or symptoms of liver disease, acute or chronic hepatitis, or ALT or AST > 1.5x ULN at Screening
- •History of renal transplantation or renal dialysis
- •GFR < 60 mL/min at Screening
- •History of diabetic ketoacidosis
- •History of greater than 3 episodes of severe hypoglycemia within 6 months of screening
- •Allergy to sulfur containing drugs
- •Treatment with other drugs or medications not allowed per study specific Disallowed Concomitant Medicines
- •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-PTP1BRx
Experimental
Weekly Dosing for 26 Weeks
干预措施: ISIS-PTP1BRx (Drug)
ISIS-PTP1BRx
Experimental
Weekly Dosing for 26 Weeks
干预措施: daily OAD (metformin and/or sulfonylurea) (Drug)
Placebo
Placebo Comparator
Weekly Dosing for 26 Weeks
干预措施: Placebo (Drug)
Placebo
Placebo Comparator
Weekly Dosing for 26 Weeks
干预措施: daily OAD (metformin and/or sulfonylurea) (Drug)
结局指标
主要结局
Incidence, severity, dose-relationship of adverse effects, and changes in laboratory evaluations as a measure of safety
时间窗: 38 weeks
Change in plasma HbA1c levels at Week 27 compared to Baseline as a measure of efficacy
时间窗: 27 weeks
次要结局
- Change in FPG, weekly average SMPG, seven-point glucose profile, lipid profile, body weight, & BMI at Week 27 compared to Baseline as a measure of efficacy(27 Weeks)
研究者
研究点 (2)
Loading locations...
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