Assessment of the Effects of LY2605541 on Triglyceride Metabolism, 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
- 15
- 试验地点
- 2
- 主要终点
- Very Low Density Lipoprotein-Triglyceride (VLDL-TG) Concentrations
研究概览
简要总结
This study has two parts. Each participant will receive a daily injection of insulin peglispro during one treatment period and a daily injection of insulin glargine during the other treatment period. Each treatment period is 3 to 4 weeks and is followed by procedures to look at how the body uses or stores fats while taking each study drug.
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) of less than 8.5%
- •Otherwise fit and healthy
- •Non smoker
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 have poor awareness of hypoglycemia
- •Taking fibrates, thyroid replacement therapy, testosterone, beta blockers or systemic corticosteroids
研究组 & 干预措施
Insulin Glargine
Stable dose of insulin glargine (0.2 - 0.8 U/kg) administered SC once daily for at least 21 days in one of two treatment periods. Dose based on prestudy basal insulin dosing regimen.
干预措施: Insulin Glargine (Biological)
Insulin Peglispro
Stable dose of insulin peglispro (0.2 - 0.8 units per kilogram [U/kg]) administered subcutaneously (SC) once daily for at least 21 days in one of two treatment periods. Dose based on prestudy basal insulin dosing regimen.
干预措施: Insulin Peglispro (Biological)
结局指标
主要结局
Very Low Density Lipoprotein-Triglyceride (VLDL-TG) Concentrations
时间窗: Day 22: 240 minutes (min) to 420 min
VLDL-TG average total concentration calculated at steady state from 240 to 420 minutes during dosing with insulin peglispro and insulin glargine.
VLDL-TG Secretion Rate
时间窗: Day 22: 240 min to 420 min
VLDL-TG secretion rates are calculated at steady state during dosing with insulin peglispro and insulin glargine.
VLDL-TG Oxidation Rate
时间窗: Day 22: 240 min to 420 min
VLDL-TG oxidation rates are calculated at steady state during dosing with insulin peglispro and insulin glargine.
VLDL-TG Clearance Rate
时间窗: Day 22: 240 min to 420 min
VLDL-TG clearance rates are calculated at steady state during dosing with insulin peglispro and insulin glargine.
次要结局
未报告次要终点