NCT00327626撤回2 期
A Phase 2, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Activity of ISIS 113715 Administered Daily in Patients With Type 2 Diabetes Mellitus Being Treated With Sulfonylurea
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 5
- 主要终点
- Evaluate the effects of ISIS 113715 on insulin sensitivity, B-cell function, proinsulin/insulin ratio, fasting insulin, C-peptide and proinsulin.
研究概览
简要总结
The aim of this study is to evaluate the safety, tolerability, and pharmacokinetics of two ISIS 113715 subcutaneous doses (15 mg and 30 mg/day) in combination with oral antidiabetic agents (OAD) versus OAD + placebo in patients with inadequately controlled type 2 diabetes, despite ongoing maximal treatment with OAD.
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 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
- •Diagnosed with type 2 diabetes mellitus of eight years or less in duration
- •Being treated with OAD at stable maximum doses [defined as at least 10 mg/day glibenclamide (preferred), or 20 mg/day glipizide, with or without at least 1,500 mg/day metformin] for at least three months prior to screening
- •Having fasting plasma glucose levels of 150-270 mg/dL and HbA1c levels of 7.5-11.0%
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 the upper limit of normal
- •Positive hepatitis B surface antigen, hepatitis C antibody, or HIV test
- •Patients with history of renal transplantation or renal dialysis or microalbuminuria defined as urine albumin > 200 mg/day
- •History of insulin use within three months of screen
- •History of diabetic ketoacidosis
- •Treatment with any thiazolidinedione (e.g., rosiglitazone) within three months of screen
- •History of lactic acidosis while on metformin therapy
- •Complications of diabetes (e.g., neuropathy, nephropathy, and retinopathy)
- •Clinically significant and currently active diseases
- •Clinical significant abnormalities in medical history, physical examination, or laboratory examination
结局指标
主要结局
Evaluate the effects of ISIS 113715 on insulin sensitivity, B-cell function, proinsulin/insulin ratio, fasting insulin, C-peptide and proinsulin.
Evaluate the safety, tolerability, and pharmacokinetics of two ISIS 113715 subcutaneous dosages in combination with OAD versus OAD + placebo.
Examine the effect of treatment with 15 and 30 mg/day ISIS 113715 on fasting plasma glucose and HbA1c.
次要结局
未报告次要终点
研究者
研究点 (5)
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