Effectiveness of a Basal Rate Reduction With LyumjevTM Versus Humalog® on the Protection From Exercise-Induced Hypoglycemia in Individuals With Type 1 Diabetes on Continuous Subcutaneous Insulin Infusion
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
- Pharmacodynamics (PD): Change in Plasma Glucose (PG) From the Start to the End of Exercise
研究概览
简要总结
This study will be conducted in participants with type 1 diabetes mellitus on continuous subcutaneous insulin infusion (CSII) or pump therapy to evaluate the effect of LY900014 (Lyumjev) on blood sugar levels during exercise using different approaches on basal rate reduction and following a test meal compared to insulin lispro (Humalog). The study may last up to approximately 10 weeks and may include up to 7 visits.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female participants with type 1 diabetes
- •Body mass index (BMI) between 18.5 and 29.0 kilograms per square meter (kg/m²), inclusive
- •Hemoglobin A1c (HbA1c) less than or equal to 8.5 percent (%)
- •Using CSII and stable insulin regimen for at least 6 months prior to inclusion into the trial
- •Able to undergo at least 1 hour of moderate-intensity exercise
排除标准
- •Are currently participating or recently participated in a clinical trial or any other type of medical research judged to be incompatible with this study
- •Have a blood loss of more than 500 milliliters (mL) within the last month
- •Have known allergies to insulin lispro, related compounds or any components of the study drug formulation
- •Have previously participated or withdrawn from this study
- •Have or used to have health problems or medical test results that, in the opinion of the doctor, could make it unsafe to participate, or could interfere with understanding the results of the study
- •Participants who have an abnormal blood pressure and/or pulse rate
- •Participants with clinically significant cardiac or pulmonary disease
研究组 & 干预措施
Treatment Sequence 1: ADBC
Period 1: Lyumjev with 50% basal rate reduction (Treatment A)
Period 2: Humalog with 100% basal rate reduction (Treatment D)
Period 3: Lyumjev with 100% basal rate reduction (Treatment B)
Period 4: Humalog with 50% basal rate reduction (Treatment C)
Participants received their assigned treatments in each of the above treatment period on Day 1 subcutaneously.
干预措施: Lyumjev with 50% basal rate reduction (Drug)
Treatment Sequence 1: ADBC
Period 1: Lyumjev with 50% basal rate reduction (Treatment A)
Period 2: Humalog with 100% basal rate reduction (Treatment D)
Period 3: Lyumjev with 100% basal rate reduction (Treatment B)
Period 4: Humalog with 50% basal rate reduction (Treatment C)
Participants received their assigned treatments in each of the above treatment period on Day 1 subcutaneously.
干预措施: Humalog with 50% basal rate reduction (Drug)
Treatment Sequence 1: ADBC
Period 1: Lyumjev with 50% basal rate reduction (Treatment A)
Period 2: Humalog with 100% basal rate reduction (Treatment D)
Period 3: Lyumjev with 100% basal rate reduction (Treatment B)
Period 4: Humalog with 50% basal rate reduction (Treatment C)
Participants received their assigned treatments in each of the above treatment period on Day 1 subcutaneously.
干预措施: Humalog with 100% basal rate reduction (Drug)
Treatment Sequence 1: ADBC
Period 1: Lyumjev with 50% basal rate reduction (Treatment A)
Period 2: Humalog with 100% basal rate reduction (Treatment D)
Period 3: Lyumjev with 100% basal rate reduction (Treatment B)
Period 4: Humalog with 50% basal rate reduction (Treatment C)
Participants received their assigned treatments in each of the above treatment period on Day 1 subcutaneously.
干预措施: Lyumjev with 100% basal rate reduction (Drug)
Treatment Sequence 2: BACD
Period 1: Lyumjev with 100% basal rate reduction (Treatment B)
Period 2: Lyumjev with 50% basal rate reduction (Treatment A)
Period 3: Humalog with 50% basal rate reduction (Treatment C)
Period 4: Humalog with 100% basal rate reduction (Treatment D)
Participants received their assigned treatments in each of the above treatment period on Day 1 subcutaneously.
干预措施: Lyumjev with 50% basal rate reduction (Drug)
Treatment Sequence 2: BACD
Period 1: Lyumjev with 100% basal rate reduction (Treatment B)
Period 2: Lyumjev with 50% basal rate reduction (Treatment A)
Period 3: Humalog with 50% basal rate reduction (Treatment C)
Period 4: Humalog with 100% basal rate reduction (Treatment D)
Participants received their assigned treatments in each of the above treatment period on Day 1 subcutaneously.
干预措施: Humalog with 50% basal rate reduction (Drug)
Treatment Sequence 2: BACD
Period 1: Lyumjev with 100% basal rate reduction (Treatment B)
Period 2: Lyumjev with 50% basal rate reduction (Treatment A)
Period 3: Humalog with 50% basal rate reduction (Treatment C)
Period 4: Humalog with 100% basal rate reduction (Treatment D)
Participants received their assigned treatments in each of the above treatment period on Day 1 subcutaneously.
干预措施: Humalog with 100% basal rate reduction (Drug)
Treatment Sequence 2: BACD
Period 1: Lyumjev with 100% basal rate reduction (Treatment B)
Period 2: Lyumjev with 50% basal rate reduction (Treatment A)
Period 3: Humalog with 50% basal rate reduction (Treatment C)
Period 4: Humalog with 100% basal rate reduction (Treatment D)
Participants received their assigned treatments in each of the above treatment period on Day 1 subcutaneously.
干预措施: Lyumjev with 100% basal rate reduction (Drug)
Treatment Sequence 3: CBDA
Period 1: Humalog with 50% basal rate reduction (Treatment C)
Period 2: Lyumjev with 100% basal rate reduction (Treatment B)
Period 3: Humalog with 100% basal rate reduction (Treatment D)
Period 4: Lyumjev with 50% basal rate reduction (Treatment A)
Participants received their assigned treatments in each of the above treatment period on Day 1 subcutaneously.
干预措施: Lyumjev with 50% basal rate reduction (Drug)
Treatment Sequence 3: CBDA
Period 1: Humalog with 50% basal rate reduction (Treatment C)
Period 2: Lyumjev with 100% basal rate reduction (Treatment B)
Period 3: Humalog with 100% basal rate reduction (Treatment D)
Period 4: Lyumjev with 50% basal rate reduction (Treatment A)
Participants received their assigned treatments in each of the above treatment period on Day 1 subcutaneously.
干预措施: Humalog with 50% basal rate reduction (Drug)
Treatment Sequence 3: CBDA
Period 1: Humalog with 50% basal rate reduction (Treatment C)
Period 2: Lyumjev with 100% basal rate reduction (Treatment B)
Period 3: Humalog with 100% basal rate reduction (Treatment D)
Period 4: Lyumjev with 50% basal rate reduction (Treatment A)
Participants received their assigned treatments in each of the above treatment period on Day 1 subcutaneously.
干预措施: Humalog with 100% basal rate reduction (Drug)
Treatment Sequence 3: CBDA
Period 1: Humalog with 50% basal rate reduction (Treatment C)
Period 2: Lyumjev with 100% basal rate reduction (Treatment B)
Period 3: Humalog with 100% basal rate reduction (Treatment D)
Period 4: Lyumjev with 50% basal rate reduction (Treatment A)
Participants received their assigned treatments in each of the above treatment period on Day 1 subcutaneously.
干预措施: Lyumjev with 100% basal rate reduction (Drug)
Treatment Sequence 4: DCAB
Period 1: Humalog with 100% basal rate reduction (Treatment D)
Period 2: Humalog with 50% basal rate reduction (Treatment C)
Period 3: Lyumjev with 50% basal rate reduction (Treatment A)
Period 4: Lyumjev with 100% basal rate reduction (Treatment B)
Participants received their assigned treatments in each of the above treatment period on Day 1 subcutaneously.
干预措施: Lyumjev with 50% basal rate reduction (Drug)
Treatment Sequence 4: DCAB
Period 1: Humalog with 100% basal rate reduction (Treatment D)
Period 2: Humalog with 50% basal rate reduction (Treatment C)
Period 3: Lyumjev with 50% basal rate reduction (Treatment A)
Period 4: Lyumjev with 100% basal rate reduction (Treatment B)
Participants received their assigned treatments in each of the above treatment period on Day 1 subcutaneously.
干预措施: Humalog with 50% basal rate reduction (Drug)
Treatment Sequence 4: DCAB
Period 1: Humalog with 100% basal rate reduction (Treatment D)
Period 2: Humalog with 50% basal rate reduction (Treatment C)
Period 3: Lyumjev with 50% basal rate reduction (Treatment A)
Period 4: Lyumjev with 100% basal rate reduction (Treatment B)
Participants received their assigned treatments in each of the above treatment period on Day 1 subcutaneously.
干预措施: Humalog with 100% basal rate reduction (Drug)
Treatment Sequence 4: DCAB
Period 1: Humalog with 100% basal rate reduction (Treatment D)
Period 2: Humalog with 50% basal rate reduction (Treatment C)
Period 3: Lyumjev with 50% basal rate reduction (Treatment A)
Period 4: Lyumjev with 100% basal rate reduction (Treatment B)
Participants received their assigned treatments in each of the above treatment period on Day 1 subcutaneously.
干预措施: Lyumjev with 100% basal rate reduction (Drug)
结局指标
主要结局
Pharmacodynamics (PD): Change in Plasma Glucose (PG) From the Start to the End of Exercise
时间窗: Start (0 minute) to end of exercise (60 minutes)
Changes in PG from the start (0 minute) to end of exercise (60 minutes) were analyzed using a mixed-effect model. The model included treatment (Lyumjev with 50% basal reduction, Lyumjev with 100% basal reduction, Humalog with 50% basal reduction, and Humalog with 100% basal reduction), sequence, period, timepoint, treatment-by-timepoint interaction as fixed effects, and participant-within-sequence as a random effect.
次要结局
- Pharmacodynamics (PD): Change From Baseline in Area Under the Concentration Versus Time Curve From Time 0 to 4 Hours [AUC(0-4)] of Postprandial Plasma Glucose (PPG) Post Mixed-Meal Tolerance Test (MMTT)(Baseline (0-hour time point prior of the MMTT), 4 hour post-meal MMTT)