A Study of LY900014 Formulation in Healthy Participants
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|ClinicalTrials.gov Identifier: NCT02942654|
Recruitment Status : Completed
First Posted : October 24, 2016
Results First Posted : April 27, 2020
Last Update Posted : April 27, 2020
|Condition or disease||Intervention/treatment||Phase|
|Healthy||Drug: LY900014 Drug: Insulin Lispro||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||32 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Double (Participant, Investigator)|
|Primary Purpose:||Basic Science|
|Official Title:||Pharmacokinetics and Glucodynamics of LY900014 Compared to Insulin Lispro Following Single-Dose Administration in Healthy Subjects|
|Study Start Date :||November 2016|
|Actual Primary Completion Date :||December 2016|
|Actual Study Completion Date :||December 2016|
Test formulation. 15-U dose of LY900014 administered subcutaneously (SC) in one of two periods.
Administered subcutaneously (SC)
Other Name: Ultra-Rapid Lispro
Active Comparator: Insulin Lispro
Reference formulation. 15-U dose of Insulin Lispro administered SC in one of two periods.
Drug: Insulin Lispro
- Pharmacokinetics (PK): Insulin Lispro Area Under the Concentration Curve From Time Zero to 8 Hours (AUC[0-8 Hours]) [ Time Frame: Predose (0), 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 70, 90, 120, 150, 180, 210, 240, 300, 330, 360, 420, and 480 minutes, post dose ]Area Under the Concentration Versus Time Curve (AUC) was measured from time zero to 8 hours (AUC[0-8 Hours]).
- Glucodynamics (GD): Total Amount of Glucose Infused (Gtot) [ Time Frame: 2.5 minutes for the first 30 minutes, then every 5 minutes until 120 minutes postdose, and then every 10 minutes until 480 minutes postdose ]Gtot is used to measure the study drug action over time as measured by the euglycaemic clamp procedure. During the euglycaemic clamp procedure, blood glucose concentrations are held constant after the administration of LY900014 or Insulin Lispro by adjusting the exogenous glucose infusion rate. Data presented were adjusted by the body weight.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02942654
|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.|
|Study Director:||Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)||Eli Lilly and Company|