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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT02752087
Date of registration: 22/04/2016
Prospective Registration: No
Primary sponsor: Eli Lilly and Company
Public title: A Study to Compare the Effects of a Test and Reference Formulation of LY900014 in Healthy Participants
Scientific title: A Study to Compare the Pharmacokinetics and Pharmacodynamics of LY900014 Test Versus Reference Formulations in Healthy Subjects
Date of first enrolment: April 2016
Target sample size: 24
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT02752087
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Basic Science. Masking: None (Open Label).  
Phase:  Phase 1
Countries of recruitment
Singapore
Contacts
Name:     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)
Address: 
Telephone:
Email:
Affiliation:  Eli Lilly and Company
Key inclusion & exclusion criteria

Inclusion Criteria:

- Female participants who can potentially get pregnant:

- Must have a negative pregnancy test at the time of screening

- Agree to continue to use a reliable method of birth control until the end of the
study

- Have a body mass index (BMI) of 18.0 to 30.0 kilogram per meter square (kg/m²),
inclusive, at screening

- Are nonsmokers, have not smoked for at least 2 months before entering the study

Exclusion Criteria:

- Are currently enrolled in a clinical trial involving an investigational product or any
other type of medical research judged not to be scientifically or medically compatible
with this study

- Have known allergies to insulin lispro, related compounds, or any components of the
formulation

- Have significant history of or current cardiovascular, respiratory, hepatic, renal,
gastrointestinal, endocrine, hematological, or neurological disorders capable of
significantly altering the absorption, metabolism, or elimination of drugs

- Intend to use over-the-counter or prescription medication within 7 and 14 days,
respectively, before dosing (apart from vitamin/mineral supplements, occasional
paracetamol, hormonal contraception, or thyroid-replacement therapy)

- Have used systemic glucocorticoids within 3 months prior to entry into the study

- Have donated blood of more than 450 milliliters (mL) or more in the last 3 months or
provided any blood donation within the last month before screening



Age minimum: 21 Years
Age maximum: 65 Years
Gender: All
Health Condition(s) or Problem(s) studied
Healthy
Intervention(s)
Drug: LY900014
Primary Outcome(s)
Pharmacokinetics (PK): Insulin Lispro Area Under the Concentration Curve From Time Zero to 8 Hours (AUC[0-8 Hours]) [Time Frame: 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 70, 90, 120, 150, 180, 240, 300, 360, 420, and 480 minutes post study dose for each treatment]
Secondary Outcome(s)
Pharmacodynamics (PD): Total Amount of Glucose Infused (Gtot) [Time Frame: Blood glucose was measured approximately every 2.5 minutes for the first 30 minutes, then every 5 minutes until 120 minutes post dose, and then every 10 minutes until 480 minutes post dose]
Secondary ID(s)
I8B-MC-ITRP
16489
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available: Yes
Date Posted: 01/05/2020
Date Completed:
URL: https://clinicaltrials.gov/ct2/show/results/NCT02752087
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