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

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05262387
Collaborator
(none)
32
Enrollment
1
Location
2
Arms
10
Anticipated Duration (Months)
3.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
32 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Basic Science
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
Actual Study Start Date :
Feb 14, 2022
Anticipated Primary Completion Date :
Dec 15, 2022
Anticipated Study Completion Date :
Dec 15, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Lyumjev

Lyumjev administered subcutaneously (SC) during a meal and following different approaches for basal reduction prior to exercise

Drug: Lyumjev
Administered SC.
Other Names:
  • LY900014

    		•
    Active Comparator: Humalog

    Humalog administered SC during a meal and following different approaches for basal reduction prior to exercise

    Drug: Humalog
    Administered SC.
    Other Names:
  • Insulin Lispro

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change From Baseline in Plasma Glucose (PG) From the Start to the End of Exercise for Each Treatment Arm [Predose up to 240 minutes postdose]

      Change From Baseline in PG From the Start to the End of Exercise for Each Treatment Arm

    Secondary Outcome Measures

    1. Change From Baseline in Postprandial Plasma Glucose (PPG) Excursion During Mixed-Meal Tolerance Test (MMTT) for Each Treatment Arm [Predose up to 240 minutes postdose]

      Change From Baseline in PPG Excursion During MMTT for Each Treatment Arm

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 55 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 LMC Clinical Research Inc. (Bayview) Toronto Ontario Canada M4G 3E8

    Sponsors and Collaborators

    • Eli Lilly and Company

    Investigators

    • Study Director: 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), Eli Lilly and Company

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Eli Lilly and Company
    ClinicalTrials.gov Identifier:
    NCT05262387
    Other Study ID Numbers:
    • 17278
    • I8B-MC-ITSU
    First Posted:
    Mar 2, 2022
    Last Update Posted:
    Jul 21, 2022
    Last Verified:
    Jul 15, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    Yes
    Keywords provided by Eli Lilly and Company
    Lyumjev
    Humalog®
    Insulin lispro
    Exercise
    Continuous Subcutaneous Insulin Infusion
    Glycemic control
    Hypoglycemia
    Type 1 Diabetes
    Additional relevant MeSH terms:
    Diabetes Mellitus
    Diabetes Mellitus, Type 1
    Insulin Lispro

    Study Results

    No Results Posted as of Jul 21, 2022