Back to resultsA Study of LY900014 (Lyumjev) Versus Insulin Lispro (Humalog) in Participants With Type 1 Diabetes
Primary Purpose
Diabetes Mellitus, Type 1
Status
Completed
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
Lyumjev
Humalog
Sponsored by
About this trial
This is an interventional basic science trial for Diabetes Mellitus, Type 1 focused on measuring Lyumjev, Humalog®, Insulin lispro, Exercise, Continuous Subcutaneous Insulin Infusion, Glycemic control, Hypoglycemia, Type 1 Diabetes
Eligibility Criteria
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- Have previously participated or withdrawn from this study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
Sites / Locations
- LMC Clinical Research Inc. (Bayview)
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Lyumjev
Humalog
Arm Description
Lyumjev administered subcutaneously (SC) during a meal and following different approaches for basal reduction prior to exercise
Humalog administered SC during a meal and following different approaches for basal reduction prior to exercise
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05262387
Brief Title
A Study of LY900014 (Lyumjev) Versus Insulin Lispro (Humalog) in Participants With Type 1 Diabetes
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 1, 2023
Overall Recruitment Status
Completed
Study Start Date
February 14, 2022 (Actual)
Primary Completion Date
March 7, 2023 (Actual)
Study Completion Date
March 7, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eli Lilly and Company
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 1
Keywords
Lyumjev, Humalog®, Insulin lispro, Exercise, Continuous Subcutaneous Insulin Infusion, Glycemic control, Hypoglycemia, Type 1 Diabetes
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lyumjev
Arm Type
Experimental
Arm Description
Lyumjev administered subcutaneously (SC) during a meal and following different approaches for basal reduction prior to exercise
Arm Title
Humalog
Arm Type
Active Comparator
Arm Description
Humalog administered SC during a meal and following different approaches for basal reduction prior to exercise
Intervention Type
Drug
Intervention Name(s)
Lyumjev
Other Intervention Name(s)
LY900014
Intervention Description
Administered SC.
Intervention Type
Drug
Intervention Name(s)
Humalog
Other Intervention Name(s)
Insulin Lispro
Intervention Description
Administered SC.
Primary Outcome Measure Information:
Title
Change From Baseline in Plasma Glucose (PG) From the Start to the End of Exercise for Each Treatment Arm
Description
Change From Baseline in PG From the Start to the End of Exercise for Each Treatment Arm
Time Frame
Predose up to 240 minutes postdose
Secondary Outcome Measure Information:
Title
Change From Baseline in Postprandial Plasma Glucose (PPG) Excursion During Mixed-Meal Tolerance Test (MMTT) for Each Treatment Arm
Description
Change From Baseline in PPG Excursion During MMTT for Each Treatment Arm
Time Frame
Predose up to 240 minutes postdose
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
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)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
LMC Clinical Research Inc. (Bayview)
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4G 3E8
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Study of LY900014 (Lyumjev) Versus Insulin Lispro (Humalog) in Participants With Type 1 Diabetes
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