| Trial ID: | L6204 |
| Source ID: | NCT04276207
|
| Associated Drug: |
Ly900014
|
| Title: |
A Study of LY900014 Versus Insulin Lispro (Humalog) on High Blood Sugar in Participants With Type 1 Diabetes Who Use Insulin Pumps
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT04276207/results
|
| Conditions: |
Diabetes Mellitus, Type 1
|
| Interventions: |
DRUG: LY900014|DRUG: Insulin Lispro
|
| Outcome Measures: |
Primary: Time to Recovery From Hyperglycemia Following Administration of LY900014 and Insulin Lispro (Humalog) After Missed Meal Bolus, Time to Recovery from Hyperglycemia was defined as tPG140 = time to achieve glucose of 140 Milligrams per deciliter (mg/dL)., Day 1: Baseline up to 5 hours after missed meal bolus|Time to Recovery From Hyperglycemia Following Administration of LY900014 and Insulin Lispro (Humalog) After Pump Suspension, Time to Recovery from Hyperglycemia was defined as tPG140 = time to achieve glucose of 140 mg/dL., Day 2: Baseline up to 5 hours after pump suspension | Secondary: Pharmacodynamics (PD): Maximum Observed Plasma Glucose (PGmax) Following Administration of LY900014 and Insulin Lispro (Humalog), PD: PGmax following administration of LY900014 and insulin lispro (Humalog), Day 1: Baseline up to 5 hours after missed meal bolus and Day 2: Baseline up to 5 hours after pump suspension|Pharmacokinetics (PK): Time to Maximum Observed Insulin Lispro Concentration (Tmax) Following Administration of LY900014 and Insulin Lispro (Humalog), PK: Tmax following administration of LY900014 and insulin lispro (Humalog), Day 1: Baseline up to 5 hours after missed meal bolus and Day 2: Baseline up to 5 hours after pump suspension
|
| Sponsor/Collaborators: |
Sponsor: Eli Lilly and Company
|
| Gender: |
ALL
|
| Age: |
ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
32
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: BASIC_SCIENCE
|
| Start Date: |
2020-02-25
|
| Completion Date: |
2020-08-10
|
| Results First Posted: |
2021-08-25
|
| Last Update Posted: |
2021-08-25
|
| Locations: |
Profil Mainz GmbH & Co. KG, Mainz, Rheinland-Pfalz, 55116, Germany
|
| URL: |
https://clinicaltrials.gov/show/NCT04276207
|
