NCT01811849已完成1 期
A Double-blind Study of the Pharmacokinetic Properties of BIOD-238 and BIOD-250 Compared to Humalog® in Subjects With Type 1 Diabetes Including Assessments of Safety and Injection Site Toleration
Biodel0 个研究点目标入组 12 人开始时间: 2012年8月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 主要终点
- Time to 1/2 maximal insulin concentration
研究概览
简要总结
A Double-blind Study of the Pharmacokinetic Properties of BIOD-238 and BIOD-250 Compared to Humalog® in Subjects with Type 1 Diabetes
详细描述
The purpose of this study is to assess the speed of absorption of BIOD-238 and BIOD-250 compared to Humalog®. Secondary objectives are to assess other pharmacokinetic characteristics of BIOD-238 and BIOD-250 compared to Humalog®, and to evaluate the safety and tolerability of BIOD-238 and BIOD-250 compared to Humalog®.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, 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
- •Age: ≥18 to ≤70 years
- •Body Mass Index: ≥18 and ≤35 kg/m2
- •Diagnosed with Type 1 Diabetes Mellitus for at least 1 year
排除标准
- •Type 2 diabetes mellitus
- •Serum C-peptide >1.0 ng/mL
- •HbA1c >10.0%
- •History of hypersensitivity to any of the components in the study medication
- •Treatment with any other investigational drug in the last 30 days before dosing.
- •Current drug or alcohol abuse, or a history of drug or alcohol abuse which in the opinion of the Investigator will impair subject safety, protocol compliance, or interpretation of study results. Caffeine, nicotine or alcohol addiction which might be expected to result in withdrawal symptoms during the course of a study dosing day would fall into this category.
研究组 & 干预措施
Humalog
Active Comparator
Subcutaneous injection
干预措施: Insulin LISPRO (Drug)
BIOD-238
Experimental
Subcutaneous injection
干预措施: Insulin LISPRO (Drug)
BIOD-250
Experimental
Subcutaneous injection
干预措施: Insulin LISPRO (Drug)
结局指标
主要结局
Time to 1/2 maximal insulin concentration
时间窗: 480 minutes
次要结局
- Visual analog scale(30 minutes)
- AUC 0-30 and AUC 0-60(60 minutes)
- Time to maximal insulin concentration(480 minutes)
- Time to 1/2 maximal insulin concentration after peak(480 minutes)
研究者
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