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Clinical Trial Details

Trial ID: L6540
Source ID: NCT03465878
Associated Drug: Ly900014
Title: A Study of LY900014 in Participants With Type 1 Diabetes Mellitus
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT03465878/results
Conditions: Type 1 Diabetes Mellitus
Interventions: DRUG: LY900014|DRUG: Insulin Lispro
Outcome Measures: Primary: Pharmacokinetics (PK): Insulin Lispro Area Under the Concentration Curve (AUC) Following Each Treatment Arm for Each Study Part, Pharmacokinetics (PK): Insulin Lispro Area Under the Concentration Curve (AUC(0 -7h)) following Each Treatment Arm for Each Study Part., Predose, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 60, 70, 90, 120, 150, 180, 240, 300, 360, and 420 minutes postdose | Secondary: Glucodynamics (GD): Area Under the Baseline Subtracted Glucose Concentration Versus Time Curve Following Each Treatment Arm for Each Study Part, Glucodynamics (GD): Area Under the Baseline Subtracted Glucose Concentration Versus Time Curve (BG∆AUC(0-5h)) Following Each Treatment Arm for Each Study Part., -30, -15, 0 (predose), 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120, 135, 150, 165, 180, 195, 210, 225, 240 and 300 minutes postdose
Sponsor/Collaborators: Sponsor: Eli Lilly and Company
Gender: ALL
Age: CHILD, ADULT
Phases: PHASE1
Enrollment: 56
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: BASIC_SCIENCE
Start Date: 2018-03-26
Completion Date: 2019-11-14
Results First Posted: 2020-06-18
Last Update Posted: 2020-06-18
Locations: LMC Endocrinology Centres Ltd., Toronto, Ontario, M4G 3E8, Canada|Kinderkrankenhaus auf der Bult, Hannover, Niedersachsen, 30173, Germany
URL: https://clinicaltrials.gov/show/NCT03465878