A Study of LY900014 Formulation at Different Injection Sites in Healthy Participants

Study Results

Results available

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

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-14

Study Completion Date

2017-11-09

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study evaluates a new formulation of insulin lispro, LY900014, a drug that lowers blood sugar. It is administered by injection into the vein and under the skin of the abdomen, thigh and arm.

The study will be conducted in healthy people to investigate the effect of different injection sites on the amount of insulin lispro in the bloodstream.

Side effects and tolerability will be documented. The study will last for about 10 weeks for each participant, including screening and follow up. Screening is required within 28 days prior to entering the study.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Study of LY900014 Formulation in Healthy Participants

NCT02942654

Healthy

COMPLETED PHASE1

A Study of LY900014 Formulations in Healthy Participants

NCT02317575

Healthy Volunteers

COMPLETED PHASE1

A Study of a New LY900014 Formulation in Healthy Participants

NCT02525744

Healthy

COMPLETED PHASE1

Study to Compare 2 Formulations of LY900014 in Healthy Participants

NCT03616977

Healthy

COMPLETED PHASE1

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

NCT02752087

Healthy

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Diabetes Mellitus, Type 2

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

LY900014 (SC Abdomen)

Single dose of 15-U of LY900014 administered subcutaneously (SC) into the abdomen in one period

Group Type EXPERIMENTAL

LY900014 (SC)

Intervention Type DRUG

Administered SC

LY900014 (SC Thigh)

Single dose of 15-U of LY900014 administered SC into the thigh in one period

Group Type EXPERIMENTAL

LY900014 (SC)

Intervention Type DRUG

Administered SC

LY900014 (SC Arm)

Single dose of 15-U of LY900014 administered SC into the arm (deltoid) in one period

Group Type EXPERIMENTAL

LY900014 (SC)

Intervention Type DRUG

Administered SC

LY900014 (IV)

Single dose of 15-U of LY900014 administered intravenously (IV) in one period

Group Type ACTIVE_COMPARATOR

LY900014 (IV)

Intervention Type DRUG

Administered IV

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

LY900014 (SC)

Administered SC

Intervention Type DRUG

LY900014 (IV)

Administered IV

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Ultra-Rapid Lispro Ultra-Rapid Lispro

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Overtly healthy male or a female (not pregnant and agreeable to take birth control measures until study completion)
* Have a body mass index (BMI) of 18 to 30 kilogram per square meter (kg/m²)
* Have normal blood pressure, pulse rate, electrocardiogram (ECG), blood and urine laboratory test results that are acceptable for the study
* Are nonsmokers, have not smoked for at least 6 months prior to entering the study

Exclusion Criteria

* Are currently participating in or completed a clinical trial within the last 30 days or any other type of medical research judged to be incompatible with this study
* Have previously participated or withdrawn from this study
* Had blood loss of more than 450 milliliters (mL) within the last 3 months

Minimum Eligible Age

21 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes