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Completed

NCT Number: NCT05262387

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

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.

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Key information

Conditions

Diabetes Mellitus, Type 1 Autoimmune Diseases Behavior Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Hypoglycemia Immune System Diseases Metabolic Diseases Motor Activity Nutritional and Metabolic Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

LMC Clinical Research Inc. (Bayview)

Toronto, Ontario, M4G 3E8, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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  • Have previously participated or withdrawn from this study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

Treatment and study plan

Lyumjev with 50% basal rate reduction

Drug

Administered SC.

Other names: LY900014

Humalog with 50% basal rate reduction

Drug

Administered SC.

Other names: Insulin Lispro

Humalog with 100% basal rate reduction

Drug

Administered SC.

Other names: Insulin Lispro

Lyumjev with 100% basal rate reduction

Drug

Administered SC.

Other names: LY900014

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Mar 2, 2022
Registry last updated
Sep 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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