A Study to Compare the Effects of a Test and Reference Formulation of LY900014 in Healthy Participants

A Study to Compare the Pharmacokinetics and Pharmacodynamics of LY900014 Test Versus Reference Formulations in Healthy Subjects

This study of healthy participants evaluated the concentration of a test LY900014 and a reference LY900014 formulation in the bloodstream and how it affected the blood sugar levels. The whole study, including screening, took up to 8 weeks to complete.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: LY900014

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• Singapore
  • Singapore, Singapore, 117597
    • 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.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: U-193 LY900014 Test; LY900014 test dose administered via subcutaneous (SC) injection	Drug: LY900014; Administered SC; Other Names: Ultra-Rapid Lispro
ACTIVE_COMPARATOR: U-95 LY900014 Reference; LY900014 reference dose administered via SC injection	Drug: LY900014; Administered SC; Other Names: Ultra-Rapid Lispro

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetics (PK): Insulin Lispro Area Under the Concentration Curve From Time Zero to 8 Hours (AUC[0-8 Hours])	PK: Insulin Lispro Area Under the Concentration Curve From Time Zero to 8 Hours (AUC[0-8 Hours])	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 Measures

Outcome Measure	Measure Description	Time Frame
Pharmacodynamics (PD): Total Amount of Glucose Infused (Gtot)	Gtot is the total glucose infusion over the clamp duration. It is used to measure the study drug action over time as measured by the euglycemic clamp procedure.	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

Collaborators and Investigators

• Sponsor: Eli Lilly and Company

Study record dates

Study Major Dates

• Study Start: April 1, 2016
• Primary Completion (ACTUAL): May 1, 2016
• Study Completion (ACTUAL): May 1, 2016

Study Registration Dates

• First Submitted: April 22, 2016
• First Submitted That Met QC Criteria: April 22, 2016
• First Posted (ESTIMATE): April 26, 2016

Study Record Updates

• Last Update Posted (ACTUAL): May 1, 2020
• Last Update Submitted That Met QC Criteria: April 20, 2020
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: 16489; I8B-MC-ITRP (OTHER: Eli Lilly and Company)