A Study of LY900014 (Lyumjev) Versus Insulin Lispro (Humalog) in Participants With Type 1 Diabetes

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Diabetes Mellitus, Type 1

Intervention / Treatment
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* Drug: Lyumjev
* Drug: Humalog


Participation Criteria
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Eligibility Criteria
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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to insulin lispro, related compounds or any components of the study drug formulation Have previously participated or withdrawn from this study Have or used to have health problems or medical test results that, in the opinion of the doctor, could make it unsafe to participate, or could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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lyumjev<br>Lyumjev administered subcutaneously (SC) during a meal and following different approaches for basal reduction prior to exercise | Drug: Lyumjev<br>* Administered SC.<br>* Other names: LY900014;|
| Active Comparator: Humalog<br>Humalog administered SC during a meal and following different approaches for basal reduction prior to exercise | Drug: Humalog<br>* Administered SC.<br>* Other names: Insulin Lispro;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Plasma Glucose (PG) From the Start to the End of Exercise for Each Treatment Arm | Change From Baseline in PG From the Start to the End of Exercise for Each Treatment Arm | Predose up to 240 minutes postdose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Postprandial Plasma Glucose (PPG) Excursion During Mixed-Meal Tolerance Test (MMTT) for Each Treatment Arm | Change From Baseline in PPG Excursion During MMTT for Each Treatment Arm | Predose up to 240 minutes postdose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lyumjev, Humalog®, Insulin lispro, Exercise, Continuous Subcutaneous Insulin Infusion, Glycemic control, Hypoglycemia, Type 1 Diabetes