Status:

COMPLETED

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

Lead Sponsor:

Eli Lilly and Company

Conditions:

Diabetes Mellitus, Type 1

Eligibility:

All Genders

18-55 years

Phase:

PHASE1

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 suga...

Eligibility Criteria

Inclusion

  • 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

  • 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  • Have previously participated or withdrawn from this study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

Key Trial Info

Start Date :

February 14 2022

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

March 7 2023

Estimated Enrollment :

25 Patients enrolled

Trial Details

Trial ID

NCT05262387

Start Date

February 14 2022

End Date

March 7 2023

Last Update

September 3 2024

Active Locations (1)

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Page 1 of 1 (1 locations)

1

LMC Clinical Research Inc. (Bayview)

Toronto, Ontario, Canada, M4G 3E8