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

Diabetes Mellitus, Type 1 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05262387
• Other study ID #: 17278
• Secondary ID: I8B-MC-ITSU
• Status: Completed
• Phase: Phase 1
• Start date: February 14, 2022
• Est. completion date: March 7, 2023

Study information

• Verified date: April 1, 2023
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: March 7, 2023
• Est. primary completion date: March 7, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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• Have previously participated or withdrawn from this study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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1

Intervention

Drug:
• Lyumjev
Administered SC.
• Humalog
Administered SC.

Locations

Country	Name	City	State
Canada	LMC Clinical Research Inc. (Bayview)	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Plasma Glucose (PG) From the Start to the End of Exercise for Each Treatment Arm	Change From Baseline in PG From the Start to the End of Exercise for Each Treatment Arm	Predose up to 240 minutes postdose
Secondary	Change From Baseline in Postprandial Plasma Glucose (PPG) Excursion During Mixed-Meal Tolerance Test (MMTT) for Each Treatment Arm	Change From Baseline in PPG Excursion During MMTT for Each Treatment Arm	Predose up to 240 minutes postdose