| Trial ID: | L6359 |
| Source ID: | NCT05262387
|
| Associated Drug: |
Lyumjev With 50% Basal Rate Reduction
|
| Title: |
A Study of LY900014 (Lyumjev) Versus Insulin Lispro (Humalog) in Participants With Type 1 Diabetes
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT05262387/results
|
| Conditions: |
Diabetes Mellitus, Type 1
|
| Interventions: |
DRUG: Lyumjev with 50% basal rate reduction|DRUG: Humalog with 50% basal rate reduction|DRUG: Humalog with 100% basal rate reduction|DRUG: Lyumjev with 100% basal rate reduction
|
| Outcome Measures: |
Primary: Pharmacodynamics (PD): Change in Plasma Glucose (PG) From the Start to the End of Exercise, Changes in PG from the start (0 minute) to end of exercise (60 minutes) were analyzed using a mixed-effect model. The model included treatment (Lyumjev with 50% basal reduction, Lyumjev with 100% basal reduction, Humalog with 50% basal reduction, and Humalog with 100% basal reduction), sequence, period, timepoint, treatment-by-timepoint interaction as fixed effects, and participant-within-sequence as a random effect., Start (0 minute) to end of exercise (60 minutes) | Secondary: Pharmacodynamics (PD): Change From Baseline in Area Under the Concentration Versus Time Curve From Time 0 to 4 Hours [AUC(0-4)] of Postprandial Plasma Glucose (PPG) Post Mixed-Meal Tolerance Test (MMTT), The outcome measure was analyzed using a mixed-effect model. The model included treatment (Lyumjev with 50% basal reduction, Lyumjev with 100% basal reduction, Humalog with 50% basal reduction, and Humalog with 100% basal reduction), sequence, and period as fixed effects, and participant-within-sequence will be included as a random effect., Baseline (0-hour time point prior of the MMTT), 4 hour post-meal MMTT
|
| Sponsor/Collaborators: |
Sponsor: Eli Lilly and Company
|
| Gender: |
ALL
|
| Age: |
ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
25
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: BASIC_SCIENCE
|
| Start Date: |
2022-02-14
|
| Completion Date: |
2023-03-07
|
| Results First Posted: |
2024-09-03
|
| Last Update Posted: |
2024-09-03
|
| Locations: |
LMC Clinical Research Inc. (Bayview), Toronto, Ontario, M4G 3E8, Canada
|
| URL: |
https://clinicaltrials.gov/show/NCT05262387
|
