Evaluation of the Counter-Regulatory Response to Hypoglycaemia Following LY2605541 Administration Compared to Insulin Glargine in Patients With Type 1 Diabetes Mellitus
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Concentration of Epinephrine
研究概览
简要总结
This study has 2 parts. Each participant will receive a daily injection of LY2605541 during one treatment period and a daily injection of insulin glargine during one treatment period. Each treatment period is 2 to 3 weeks and is followed by a procedure to lower blood sugar levels to see how the body recovers after each treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
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
- •Type 1 diabetic for more than 1 year with glycated hemoglobin (HbA1c) less than 9%
- •Otherwise fit and healthy
- •Nonsmoker
排除标准
- •Taking medication or supplements other than insulin to control diabetes
- •Suffered a hypoglycemic event in the last 12 months that required hospitalization or has poor awareness of hypoglycemia
研究组 & 干预措施
Insulin Glargine
Stable dose of insulin glargine (0.2 to 0.6 U/kg) administered SQ once daily for at least 14 days in 1 of 2 treatment periods. Dose based on prestudy basal insulin dosing regimen.
干预措施: Insulin Glargine (Biological)
LY2605541
Stable dose of LY2605541 (0.2 to 0.6 units per kilogram [U/kg]) administered subcutaneously (SQ) once daily for at least 14 days in 1 of 2 treatment periods. Dose based on prestudy basal insulin dosing regimen.
干预措施: LY2605541 (Biological)
结局指标
主要结局
Concentration of Epinephrine
时间窗: 30, 15, and 0 minutes Preclamp; 10, 20, and 30 minutes Post-Clamp
Epinephrine levels are presented. Each participant's measurements at 30, 15, and 0 minutes preclamp on the day of the clamp were averaged for the baseline value, and measurements at blood glucose (BG) level attainment and +10, 20, and 30 minutes were averaged for the BG nadir value.
次要结局
- Concentration of Glucagon(30, 15, and 0 minutes Preclamp; 10, 20, and 30 minutes Post-Clamp)
- Amount of Glucose Required to Maintain BG of 72 mg/dL(30, 15, and 0 minutes Preclamp; 10, 20, and 30 minutes Post-Clamp)
- Concentration of Growth Hormone(30, 15, and 0 minutes Preclamp; 10, 20, and 30 minutes Post-Clamp)
- Concentration of Norepinephrine(30, 15, and 0 minutes Preclamp; 10, 20, and 30 minutes Post-Clamp)
- Amount of Glucose Required to Reach Blood Glucose (BG) of 72 mg/dL(30, 15, and 0 minutes Preclamp; 10, 20, and 30 minutes Post-Clamp)
- Concentration of Cortisol(30, 15, and 0 minutes Preclamp; 10, 20, and 30 minutes Post-Clamp)