A Study of LY900014 in Healthy Chinese Participants
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|ClinicalTrials.gov Identifier: NCT04049123|
Recruitment Status : Completed
First Posted : August 7, 2019
Results First Posted : November 16, 2021
Last Update Posted : November 16, 2021
|Condition or disease||Intervention/treatment||Phase|
|Healthy||Drug: LY900014 Drug: Insulin Lispro||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Intervention Model:||Crossover Assignment|
|Primary Purpose:||Basic Science|
|Official Title:||A Study to Evaluate the Pharmacokinetics and Glucodynamics of LY900014 Following Single Dose Administration in Healthy Chinese Subjects|
|Actual Study Start Date :||November 18, 2019|
|Actual Primary Completion Date :||October 23, 2020|
|Actual Study Completion Date :||October 23, 2020|
Active Comparator: Insulin Lispro (Humalog)
15 units (U) Insulin Lispro (Humalog) administered once, subcutaneously (SC), in one of three study periods.
Drug: Insulin Lispro
7 U, and 15 U LY900014 administered once, SC, in two of three study periods.
Other Name: Ultra-Rapid Lispro
- Pharmacokinetics (PK): Insulin Lispro Area Under the Serum Concentration Versus Time Curve From Time Zero to 10 Hours Postdose (AUC[0-10h]) [ Time Frame: Day 1: Predose, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 70, 90, 120, 150, 180, 240, 300, 360, 420, 480, 540, and 600 minutes postdose ]PK: Insulin Lispro AUC(0-10h)
- Pharmacodynamics (PD): Total Amount of Glucose Infused (Gtot) [ Time Frame: Day 1: Predose: -10, -20, -30 minutes; During clamp: every 2.5 to 3 minutes for the first 30 minutes; every 5 minutes for 30 to 120 minutes; every 10 minutes for 120 to 480 minutes and every 20 minutes for 480 to 600 minutes postdose ]Gtot is the total amount of glucose infused over the duration of the clamp procedure (10 hours) for each study period.
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): NCT04049123
|West China Hospital Sichuan University|
|Cheng Du, Cn-51, China, 610041|
|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|