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Clinical Trial Details

Trial ID: L6481
Source ID: NCT03232983
Associated Drug: Ly900014 (Sc)
Title: A Study of LY900014 Formulation at Different Injection Sites in Healthy Participants
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT03232983/results
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: LY900014 (SC)|DRUG: LY900014 (IV)
Outcome Measures: Primary: Pharmacokinetics: Insulin Lispro Area Under the Concentration Versus Time Curve (AUC) Following LY900014 Administration, Pharmacokinetics(PK): Insulin lispro AUC from time zero to 10 hours post dose \[AUC(0-10h)\]., Day 1: Pre-dose, 2.5, 5, 10, 15, 20, 25, 30, 40, 60, 70, 90, 120, 150, 180, 210, 240, 300, 360, 420, 480, 540, and 600 minutes post-dose | Secondary: Total Amount of Glucose Infused (Gtot) Over Duration of the Clamp Procedure, Glucodynamics: Gtot is the total glucose infusion over the clamp duration (10 hours) and is used to measure the study drug action over time as measured by the euglycemic clamp procedure. During the euglycemic clamp procedure, blood glucose concentrations are held constant after the administration of LY900014 by adjusting the exogenous glucose infusion rate., Every 10 minutes for 30 minutes predose, every 2.5 minutes for 30 minutes, then every 5 minutes for 120 minutes, then every 10 minutes for 120 to 480 minutes and every 10 minutes for 480 to 600 minutes post-dose
Sponsor/Collaborators: Sponsor: Eli Lilly and Company
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE1
Enrollment: 28
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: BASIC_SCIENCE
Start Date: 2017-08-14
Completion Date: 2017-11-09
Results First Posted: 2020-04-30
Last Update Posted: 2020-04-30
Locations: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician., Singapore, 117597, Singapore
URL: https://clinicaltrials.gov/show/NCT03232983