Clinical trial NCT05262387: A Study of LY900014 (Lyumjev) Versus Insulin Lispro (Humalog) in Participants With Type 1 Diabetes
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes Mellitus, Type 1
Keywords: Lyumjev
Humalog®
Insulin lispro
Exercise
Continuous Subcutaneous Insulin Infusion
Glycemic control
Hypoglycemia
Type 1 Diabetes
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2022-03-02
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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* Have previously participated or withdrawn from this study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

Primary outcomes:
measure: Pharmacodynamics (PD): Change in Plasma Glucose (PG) From the Start to the End of Exercise
timeFrame: Start (0 minute) to end of exercise (60 minutes)
Secondary outcomes:
measure: 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)
timeFrame: Baseline (0-hour time point prior of the MMTT), 4 hour post-meal MMTT
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: LMC Clinical Research Inc. (Bayview)
state: Ontario
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References: