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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-30

Study Completion Date

2016-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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U-193 LY900014 Test

LY900014 test dose administered via subcutaneous (SC) injection

Group Type EXPERIMENTAL

LY900014

Intervention Type DRUG

Administered SC

U-95 LY900014 Reference

LY900014 reference dose administered via SC injection

Group Type ACTIVE_COMPARATOR

LY900014

Intervention Type DRUG

Administered SC

Interventions

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LY900014

Administered SC

Intervention Type DRUG

Other Intervention Names

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Ultra-Rapid Lispro

Eligibility Criteria

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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

Minimum Eligible Age

21 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes