A Single-blind Crossover Study of the Pharmacokinetic and Postprandial Glucose Dynamics of BIOD-531 Compared to Humulin® R U-500 and Humalog® Mix75/25™ in Subjects With Type 2 DM Who Are Treated With ≥ 150 Units of Insulin Per Day
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Post-breakfast glucose exposure (AUC)
研究概览
简要总结
The study is designed to compare meal time glucose control associated with BIOD-531, a rapidly absorbed concentrated insulin to that associated with Humalog Mix 75/25 and Humulin R U-500 in patients with diabetes and severe insulin resistance.
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
- Single (Participant)
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
- •BMI > 25 kg/m2
- •Diabetes Mellitus using ≥ 150 units of insulin or insulin analog per day and/or ≥ 100 units of insulin or insulin analog at a single dosing session for at least 1 month prior to screening
- •HbA1c < 10.0%
排除标准
- •History of bariatric surgery
- •Corticosteroid therapy
- •Significant cardiovascular or other major organ disease
- •Females who are breast feeding or pregnant
- •A sexually active person not using adequate contraceptive methods
研究组 & 干预措施
BIOD-531 pre-meal
Subcutaneous injections of 1.2 U/kg before the start of a standardized breakfast and 0.8 U/kg before the start of a standardized dinner.
干预措施: BIOD-531 (Drug)
Humalog Mix 75/25 pre-meal
Subcutaneous injections of 1.2 U/kg before the start of a standardized breakfast and 0.8 U/kg before the start of a standardized dinner.
干预措施: Humalog Mix 75/25 (Drug)
Humulin R U-500 pre-meal
Subcutaneous injections of 1.2 U/kg before the start of a standardized breakfast and 0.8 U/kg before the start of a standardized dinner.
干预措施: Humulin R U-500 (Drug)
BIOD-531 post-meal
Subcutaneous injections of 1.2 U/kg 20 minutes after the start of a standardized breakfast and 0.8 U/kg 20 minutes after the start of a standardized dinner.
干预措施: BIOD-531 (Drug)
结局指标
主要结局
Post-breakfast glucose exposure (AUC)
时间窗: 0-330 minutes
次要结局
- Insulin exposure (AUC)(0-1440 minutes)
- Maximal insulin concentration(0-330 and 660-1020 minutes)
- Post-lunch and post-dinner glucose exposures (AUC)(330-660 and 660-1020 minutes)
- Injection site toleration (VAS and severity scales)(30 and 690 minutes)
- Speed of insulin absorption (Times to 50%, 90%, maximal insulin concentrations)(0-330 and 660-1020 minutes)