NCT01681290已完成2 期
A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of CBX129801 (Ersatta™), Long-Acting Synthetic C-Peptide, in Type 1 Diabetes Mellitus Subjects With Mild to Moderate Diabetic Peripheral Neuropathy
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
- 250
- 主要终点
- Bilateral change in sensory nerve conduction velocity
研究概览
简要总结
The purpose of the study is to determine the beneficial effects of CBX129801 (PEGylated synthetic human C-peptide) following weekly subcutaneous administration for 12 months in type 1 diabetes mellitus patients (T1DM) with mild to moderate diabetic peripheral neuropathy (DPN).
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
- •Give informed consent;
- •18-65 years old;
- •Have type 1 diabetes mellitus for a minimum of 5 years, with a stable diabetic regimen (for at least 3 months);
- •Have clinical signs of diabetic peripheral neuropathy at screening;
- •Have abnormal sural nerve conduction observed bilaterally during screening;
- •Be C-peptide deficient;
- •Be in good general health (besides having type 1 diabetes mellitus);
- •Practice effective contraception during and for at least 12 weeks after study participation;
- •Have a body mass index (BMI) ≥18.0 and <35.0 kg/m
排除标准
- •Any significant cardiovascular, hematological, lymphatic, immunologic, urologic, dermatologic, psychiatric, renal, hepatic, pulmonary, endocrine (except for diabetes mellitus), central nervous, gastrointestinal, or other major disease;
- •Unstable or inadequate glucose control;
- •Any clinically significant laboratory value at screening;
- •Occurrence of a severe, unexplainable hypoglycemic event (defined as requiring the assistance of another individual) within 6 months of Day 0, or recurrent episodes of non-severe hypoglycemia (≥3 per week on average) that are deemed clinically significant by the Investigator;
- •Have had an islet cell, kidney, and/or pancreas transplant;
- •If female, is pregnant or lactating;
- •History of alcohol or substance abuse within 2 years;
- •Positive screen for hepatitis B, hepatitis C antibody, or human immunodeficiency virus (HIV) antibody;
- •Initiation of treatment or change of dose of medication that could affect peripheral nerve function within 60 days;
- •Previous treatment with CBX129801 or unmodified C-peptide;
- •Receipt of an investigational product or therapeutic device, or participation in a drug research study, within a period of 30 days;
- •Chronic use of oral steroids or use of Ampyra (dalfampridine) within 60 days.
研究组 & 干预措施
CBX129801 High Dose
Experimental
Solution for injection, 2.4 mg, weekly for 52 weeks
干预措施: CBX129801 (Drug)
CBX129801 Low Dose
Experimental
Solution for injection, 0.8 mg, weekly for 52 weeks
干预措施: CBX129801 (Drug)
结局指标
主要结局
Bilateral change in sensory nerve conduction velocity
时间窗: Predose and 12 months post dose
次要结局
- Clinical composite score(Predose and 6 and 12 months post dose)
- Pain Intensity due to DPN(Predose and 12 months post dose)
- Sexual function questionnaires(Predose and 6 and 12 months post dose)
- Quality of life questionnaire(Predose and 12 months post dose)
- Vibration perception threshold(Predose and 6 and 12 months post dose)
研究者
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