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A Study of LY900014 (Lyumjev) Versus Insulin Lispro (Humalog) in Participants With Type 1 Diabetes | Clinical Trials | Clareo Health

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

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

NCT05262387•Eli Lilly and Company

View on ClinicalTrials.gov

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

Age

18 - 55 years

Sex

ALL

Healthy Volunteers

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•Have previously participated or withdrawn from this study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

Locations (1)

LMC Clinical Research Inc. (Bayview)

Toronto, Ontario, Canada

Key Dates

Start Date

February 14, 2022

Primary Completion Date

March 7, 2023

Completion Date

March 7, 2023

Last Updated

September 3, 2024

Enrollment

ACTUAL participants

Conditions

Diabetes Mellitus, Type 1

Interventions

Lyumjev with 50% basal rate reduction

DRUG

Humalog with 50% basal rate reduction

DRUG

Humalog with 100% basal rate reduction

DRUG

Lyumjev with 100% basal rate reduction

DRUG

A Safety, Tolerability, and Efficacy Study of VX-880 in Participants With Type 1 Diabetes

NCT04786262

Diabetes Mellitus, Type 1Impaired Hypoglycemic Awareness+1 more

View study

RECRUITINGNA

Fasted Exercise Training in Type 1 Diabetes (FED-T1D)

NCT06748963

Diabetes Mellitus, Type 1

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 3, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

A Safety, Tolerability, and Efficacy Study of VX-880 in Participants With Type 1 Diabetes

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Closed Loop and Education for Hypoglycemia Awareness Restoration

A Research Study of a New Medicine NNC0363-1063 in Participants With Type 1 Diabetes

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Repeat BCG Vaccinations For The Treatment Of Pediatric Type 1 Diabetes