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

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: Diabetes Mellitus, Type 1
• Intervention / Treatment: Drug: Lyumjev; Drug: Humalog

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Phase 1

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

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• Have previously participated or withdrawn from this study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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Eli Lilly and Company

Study record dates

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): April 5, 2023
• Last Update Submitted That Met QC Criteria: April 4, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Hypoglycemia; Exercise; Type 1 Diabetes; Glycemic control; Continuous Subcutaneous Insulin Infusion; Lyumjev; Humalog®; Insulin lispro
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1; Hypoglycemic Agents; Physiological Effects of Drugs; Insulin Lispro
• 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