| Trial ID: | L2015 |
| Source ID: | NCT04161976
|
| Associated Drug: |
Ly900027
|
| Title: |
A Study of LY900027 Given by Insulin Pump to Participants With Type 1 Diabetes Mellitus
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Mellitus, Type 1
|
| Interventions: |
DRUG: LY900027|DRUG: Insulin Lispro
|
| Outcome Measures: |
Primary: Pharmacokinetics (PK): Pharmacokinetics (PK): Area Under the Insulin Lispro Curve (AUC) 0 to 5 hours after Bolus Administration Prior to a Mixed Meal Tolerance Text (MMTT), PK: AUC after Bolus Administration Prior to a MMTT, Day 1 through Day 10 in each dosing period|PK: Maximum Observed Insulin Lispro Concentration (Cmax), PK: C PK: Cmax, Day 1 through Day 10 in each dosing period | Secondary: Pharmacodynamics (PD): Incremental Area Under the Plasma Glucose Curve Above Baseline Between 0-5 hours After Bolus Infusion, PD: Incremental Area Under the Plasma Glucose Curve Above Baseline Between 0-5 hours After Bolus Infusion, Day 1 through Day 10 in each dosing period|PD: Total Daily Insulin Dose, PD: Total Daily Insulin Dose, Day 1 through Day 10 in each dosing period|Duration Until Catheter Failure, Duration Until Catheter Failure, Day -1 through Day 10 in each dosing period
|
| Sponsor/Collaborators: |
Sponsor: Eli Lilly and Company
|
| Gender: |
ALL
|
| Age: |
ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
20
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: BASIC_SCIENCE
|
| Start Date: |
2019-12-27
|
| Completion Date: |
2020-07-14
|
| Results First Posted: |
|
| Last Update Posted: |
2020-08-05
|
| Locations: |
Profil Institut für Stoffwechselforschung, Neuss, Nordrhein-Westfalen, 41460, Germany
|
| URL: |
https://clinicaltrials.gov/show/NCT04161976
|
