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

Lilly

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: LY900014

Study type: Interventional

Funder types: Industry

Identifiers

NCT02752087

16489

I8B-MC-ITRP (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: All

Ages: 21 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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24 participants in 2 patient groups

U-193 LY900014 Test

Experimental group

Description:

LY900014 test dose administered via subcutaneous (SC) injection

Treatment:

Drug: LY900014

U-95 LY900014 Reference

Active Comparator group

Description:

LY900014 reference dose administered via SC injection

Treatment:

Drug: LY900014