Evaluation of the Effects of Insulin Peglispro (LY2605541) on Respiratory Quotient During Sleep and Response to Hyperinsulinemia Compared With That of 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
- 27
- 试验地点
- 2
- 主要终点
- Sleep Respiratory Quotient (RQ) in Type 1 Diabetes Mellitus (T1DM)
研究概览
简要总结
This is a two-period study of participants with type 1 diabetes mellitus (T1DM). In each period, participants will receive once daily injections of stable dose LY2605541 or insulin glargine for 28 to 35 days followed by procedures to look at how the body uses or stores fats and sugars. Participants will continue to use meal time insulin throughout the study. Healthy participants will also enroll in the study. They will not receive any study medication.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Type 1 Diabetics:
- •T1DM for more than 1 year with Hemoglobin A1c (HbA1c) of less than 9.5%
- •All Participants:
- •Otherwise fit and healthy
- •Non smoker
排除标准
- •Type 1 Diabetics:
- •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
- •All Participants:
- •Taking fibrates, thyroid replacement therapy, testosterone, beta blockers or systemic corticosteroids
研究组 & 干预措施
Insulin Glargine/Insulin Peglispro
Insulin glargine administered to participants with T1DM SQ QD for 28 to 35 days in one of two treatment periods. Dose is based on participant's prestudy basal insulin dosing regimen. Participants continue to use mealtime insulin. Insulin peglispro (LY2605541) administered to participants with T1DM subcutaneously (SQ) once daily (QD) for 28 to 35 days in one of two treatment periods. Dose is based on participant's prestudy basal insulin dosing regimen.
干预措施: Insulin Glargine (Biological)
Insulin Peglispro/Insulin Glargine
Insulin peglispro (LY2605541) administered to participants with T1DM subcutaneously (SQ) once daily (QD) for 28 to 35 days in one of two treatment periods. Dose is based on participant's prestudy basal insulin dosing regimen. Insulin glargine administered to participants with T1DM SQ QD for 28 to 35 days in one of two treatment periods. Dose is based on participant's prestudy basal insulin dosing regimen. Participants continue to use mealtime insulin.
干预措施: LY2605541 (Biological)
Control
Control Arm. Untreated healthy participants.
结局指标
主要结局
Sleep Respiratory Quotient (RQ) in Type 1 Diabetes Mellitus (T1DM)
时间窗: Day 30 post dose, overnight period (0000 to 0600 hours)
Lipid or glucose metabolism was assessed by the measurement of respiratory quotient (RQ) during sleep using whole room calorimetry. RQ is a calculation of basal metabolic rate (BMR) when estimated from carbon dioxide production. It is calculated from the ratio of carbon dioxide produced by the body to oxygen consumed by the body using whole room calorimetry (WRC).
次要结局
- Total Number of Minutes of Lipid Oxidation (RQ Below 7.6) in T1DM and Healthy Participants(Day 5, every minute through 23 hour period)
- Lipid Oxidation in T1DM and Healthy Participants(Day 30 post dose, overnight period (0000 to 0600 hours))
- Basal Metabolic Rate (BMR) for T1DM(Day 30 post dose, overnight period (0000 to 0600 hours))
- Sleep Respiratory Quotient (RQ) of Untreated Healthy Participants(Day 5, overnight period (0000 to 0600 hours))
- Change in RQ, Pre-breakfast to Post-breakfast Meal, in T1DM(Day 30 0830 to 0854 hours, Day 30 1000 to 1054 hours)