A Study of LY900014 (Lyumjev) Versus Insulin Lispro (Humalog) in Participants With Type 1 Diabetes
NCT ID: NCT05262387
Last Updated: 2024-09-03
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
25 participants
INTERVENTIONAL
2022-02-14
2023-03-07
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
DOUBLE
Study Groups
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Treatment Sequence 1: ADBC
Period 1: Lyumjev with 50% basal rate reduction (Treatment A)
Period 2: Humalog with 100% basal rate reduction (Treatment D)
Period 3: Lyumjev with 100% basal rate reduction (Treatment B)
Period 4: Humalog with 50% basal rate reduction (Treatment C)
Participants received their assigned treatments in each of the above treatment period on Day 1 subcutaneously.
Lyumjev with 50% basal rate reduction
Administered SC.
Humalog with 50% basal rate reduction
Administered SC.
Humalog with 100% basal rate reduction
Administered SC.
Lyumjev with 100% basal rate reduction
Administered SC.
Treatment Sequence 2: BACD
Period 1: Lyumjev with 100% basal rate reduction (Treatment B)
Period 2: Lyumjev with 50% basal rate reduction (Treatment A)
Period 3: Humalog with 50% basal rate reduction (Treatment C)
Period 4: Humalog with 100% basal rate reduction (Treatment D)
Participants received their assigned treatments in each of the above treatment period on Day 1 subcutaneously.
Lyumjev with 50% basal rate reduction
Administered SC.
Humalog with 50% basal rate reduction
Administered SC.
Humalog with 100% basal rate reduction
Administered SC.
Lyumjev with 100% basal rate reduction
Administered SC.
Treatment Sequence 3: CBDA
Period 1: Humalog with 50% basal rate reduction (Treatment C)
Period 2: Lyumjev with 100% basal rate reduction (Treatment B)
Period 3: Humalog with 100% basal rate reduction (Treatment D)
Period 4: Lyumjev with 50% basal rate reduction (Treatment A)
Participants received their assigned treatments in each of the above treatment period on Day 1 subcutaneously.
Lyumjev with 50% basal rate reduction
Administered SC.
Humalog with 50% basal rate reduction
Administered SC.
Humalog with 100% basal rate reduction
Administered SC.
Lyumjev with 100% basal rate reduction
Administered SC.
Treatment Sequence 4: DCAB
Period 1: Humalog with 100% basal rate reduction (Treatment D)
Period 2: Humalog with 50% basal rate reduction (Treatment C)
Period 3: Lyumjev with 50% basal rate reduction (Treatment A)
Period 4: Lyumjev with 100% basal rate reduction (Treatment B)
Participants received their assigned treatments in each of the above treatment period on Day 1 subcutaneously.
Lyumjev with 50% basal rate reduction
Administered SC.
Humalog with 50% basal rate reduction
Administered SC.
Humalog with 100% basal rate reduction
Administered SC.
Lyumjev with 100% basal rate reduction
Administered SC.
Interventions
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Lyumjev with 50% basal rate reduction
Administered SC.
Humalog with 50% basal rate reduction
Administered SC.
Humalog with 100% basal rate reduction
Administered SC.
Lyumjev with 100% basal rate reduction
Administered SC.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
55 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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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)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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LMC Clinical Research Inc. (Bayview)
Toronto, Ontario, Canada
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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I8B-MC-ITSU
Identifier Type: OTHER
Identifier Source: secondary_id
17278
Identifier Type: -
Identifier Source: org_study_id
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