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

August 28, 2024 updated by: Eli Lilly and Company

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M4G 3E8
        • LMC Clinical Research Inc. (Bayview)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Description

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  • Have previously participated or withdrawn from this study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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: Lyumjev with 50% basal rate reduction
Administered SC.
Other Names:
  • LY900014
Drug: Humalog with 50% basal rate reduction
Administered SC.
Other Names:
  • Insulin Lispro
Drug: Humalog with 100% basal rate reduction
Administered SC.
Other Names:
  • Insulin Lispro
Drug: Lyumjev with 100% basal rate reduction
Administered SC.
Other Names:
  • LY900014
Experimental: 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.
Drug: Lyumjev with 50% basal rate reduction
Administered SC.
Other Names:
  • LY900014
Drug: Humalog with 50% basal rate reduction
Administered SC.
Other Names:
  • Insulin Lispro
Drug: Humalog with 100% basal rate reduction
Administered SC.
Other Names:
  • Insulin Lispro
Drug: Lyumjev with 100% basal rate reduction
Administered SC.
Other Names:
  • LY900014
Experimental: 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.
Drug: Lyumjev with 50% basal rate reduction
Administered SC.
Other Names:
  • LY900014
Drug: Humalog with 50% basal rate reduction
Administered SC.
Other Names:
  • Insulin Lispro
Drug: Humalog with 100% basal rate reduction
Administered SC.
Other Names:
  • Insulin Lispro
Drug: Lyumjev with 100% basal rate reduction
Administered SC.
Other Names:
  • LY900014
Experimental: 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.
Drug: Lyumjev with 50% basal rate reduction
Administered SC.
Other Names:
  • LY900014
Drug: Humalog with 50% basal rate reduction
Administered SC.
Other Names:
  • Insulin Lispro
Drug: Humalog with 100% basal rate reduction
Administered SC.
Other Names:
  • Insulin Lispro
Drug: Lyumjev with 100% basal rate reduction
Administered SC.
Other Names:
  • LY900014

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pharmacodynamics (PD): Change in Plasma Glucose (PG) From the Start to the End of Exercise
Time Frame: 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.
Start (0 minute) to end of exercise (60 minutes)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Time Frame: Baseline (0-hour time point prior of the MMTT), 4 hour post-meal MMTT
The outcome measure was 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, and period as fixed effects, and participant-within-sequence will be included as a random effect.
Baseline (0-hour time point prior of the MMTT), 4 hour post-meal MMTT

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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 record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 14, 2022

Primary Completion (Actual)

March 7, 2023

Study Completion (Actual)

March 7, 2023

Study Registration Dates

First Submitted

February 24, 2022

First Submitted That Met QC Criteria

February 24, 2022

First Posted (Actual)

March 2, 2022

Study Record Updates

Last Update Posted (Actual)

September 3, 2024

Last Update Submitted That Met QC Criteria

August 28, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17278
  • I8B-MC-ITSU (Other Identifier: Eli Lilly and Company)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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