A Study of Various Formulations of LY900014 in Healthy Participants

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-31

Study Completion Date

2016-02-29

Brief Summary

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This study will evaluate how quickly the body absorbs, breaks down, and gets rid of the different formulations of LY900014. This study will determine how the different formulations, when injected under the skin, will affect the blood sugar levels in the body, and how safe it is.

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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

SINGLE

Participants

Study Groups

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LY900014 Test B

Test formulation B: Single dose of LY900014 formulation administered subcutaneously (SC) in one of five periods

Group Type EXPERIMENTAL

LY900014

Intervention Type DRUG

Administered subcutaneously (SC)

LY900014 Test A

Test formulation B: Single dose of LY900014 formulation administered SC in one of five periods

Group Type EXPERIMENTAL

LY900014

Intervention Type DRUG

Administered subcutaneously (SC)

LY900014 Test C

Test formulation C: Single dose of LY900014 formulation administered SC in one of five periods

Group Type EXPERIMENTAL

LY900014

Intervention Type DRUG

Administered subcutaneously (SC)

LY900014 Test D

Formulation D: Single dose of LY900014 formulation administered SC in one of five periods

Group Type EXPERIMENTAL

LY900014

Intervention Type DRUG

Administered subcutaneously (SC)

Insulin Lispro

Reference formulation: Single dose of lispro administered SC in one of five periods

Group Type ACTIVE_COMPARATOR

Insulin lispro (Humalog)

Intervention Type DRUG

Administered SC

Interventions

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LY900014

Administered subcutaneously (SC)

Intervention Type DRUG

Insulin lispro (Humalog)

Administered SC

Intervention Type DRUG

Other Intervention Names

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Ultra-Rapid Lispro Humalog LY275585

Eligibility Criteria

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Inclusion Criteria

* Overtly healthy male or a female (not pregnant and agreeable to take birth control measures until one month after study completion)
* Must have a body mass index (BMI) of 18.0 to 30 kilogram per square meter (kg/m²) (inclusive) at the time of study screening
* Have normal blood pressure, pulse rate, electrocardiogram (ECG), blood and urine laboratory test results that are acceptable for the study
* Are non-smokers or have not smoked for at least 2 months prior to entering the study, and agree not to smoke (cigars, cigarettes, or pipes) or use smokeless tobacco for the duration of the study
* Have veins suitable for easy blood collection and glucose solution infusion

Exclusion Criteria

* Have known allergies to insulin lispro or compounds related to these drugs, or any components of the study drug
* Show signs of having an infection or infectious disease at the time of study entry

Minimum Eligible Age

21 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes