A Double-blind Study of the Pharmacokinetic and Pharmacodynamic Properties of BIOD-123 and BIOD-125 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
- 12
- 主要终点
- Speed of absorption (TINS-50%-early) of BIOD-123 and BIOD-125 versus Humalog.
研究概览
简要总结
The primary objective is to assess the speed of absorption of BIOD-123 and BIOD-125 and compare them to Humalog.
详细描述
The primary objective is to assess the speed of absorption of BIOD-123 and BIOD-125 and compare them to Humalog.
The secondary objectives are to assess other pharmacokinetic characteristics of BIOD-123 and BIOD-125 and compare those to Humalog®, to assess pharmacodynamic characteristics of BIOD-123 and BIOD-125 and compare those to Humalog®, and to evaluate the safety and tolerability of BIOD-123 and BIOD-125 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 - ≤70 years
- •BMI: ≥18 - ≤30 kg/m2
- •Diagnosed with type 1 diabetes mellitus for at least 1 year
- •Insulin antibody ≤10 μU/mL at screening
排除标准
- •Type 2 diabetes mellitus
- •History of >2 severe hypoglycemic events within the 3 months prior to screening
- •Serum C-peptide >1.0 ng/mL
- •Hemoglobin A1c (HbA1c) >10.0%
- •Females who were breast feeding, pregnant, or intending to become pregnant during the study
- •A sexually active person who was not using adequate contraceptive methods
- •Positive serology for human immunodeficiency virus (HIV), Hepatitis B, or Hepatitis C
- •Abnormal ECG, safety lab, or physical examination results that were deemed clinically significant by the investigator
研究组 & 干预措施
BIOD-123
SC administration of 0.20 U/kg
干预措施: BIOD-123 (Drug)
BIOD-125
SC administration of 0.20 U/kg
干预措施: BIOD-125 (Drug)
Humalog
SC administration of 0.20 U/kg
干预措施: Humalog (Drug)
结局指标
主要结局
Speed of absorption (TINS-50%-early) of BIOD-123 and BIOD-125 versus Humalog.
时间窗: 0-30, 0-60, 0-90, 0-480, and 120-480 minutes
Subjects were to receive study drug at 3 separate dosing visits separated by 3-28 days. The estimated duration of study participation for 1 subject was approximately 12 weeks. The estimated duration of the study was approximately 6 months.
次要结局
未报告次要终点