A Double-blind Study of the Pharmacokinetic and Pharmacodynamic Properties of BIOD-105 and BIOD-107 Compared to Humalog® in Subjects With Type 1 Diabetes Including Assessments of Safety and Injection Site Toleration
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Speed of absorption
研究概览
简要总结
The primary objective of this study is to assess the speed of absorption and onset of action of BIOD-105 and BIOD-107 and compare them to Humalog®.
详细描述
The secondary objectives of this study are to assess other pharmacokinetic characteristics of BIOD-105 and BIOD-107 and compare those to Humalog®, to assess other pharmacodynamic characteristics of BIOD-105 and BIOD-107 and compare those to Humalog®, and to evaluate the safety and tolerability of BIOD-105 and BIOD-107 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
- 19 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must present with the following:
- •Body Mass Index: ≥ 18 - ≤ 28 kg/m2
- •Diagnosed with type 1 diabetes mellitus for at least 1 year
- •Insulin antibody less than or equal to 10 μU/mL at screening
排除标准
- •Subjects presenting with any of the following will not be included in the study:
- •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 screening visit
- •Regular smoking as assessed clinically by the Investigator.
研究组 & 干预措施
Humalog®
Humalog®, administered subcutaneously on 1 occasion
干预措施: Insulin LISPRO (Drug)
BIOD- 105
BIOD- 105 administered subcutaneously on 1 occasion
干预措施: recombinant human insulin (Drug)
BIOD-107
BIOD-107 administered subcutaneously on 1 occasion
干预措施: recombinant human insulin (Drug)
结局指标
主要结局
Speed of absorption
时间窗: 480 minutes
The speed of absorption will be assessed by the time to reach 50% of maximum insulin concentration (TINS-50%-early, time before CINS max) and the onset of action will be assessed by the time to reach 50% of the maximum glucose infusion rate (TGIR-50%- early).
次要结局
未报告次要终点