Study to Compare 2 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.

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

69 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-03

Study Completion Date

2018-10-19

Brief Summary

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

The study involves a comparison of 2 formulations of LY900014, which is a type of fast acting insulin. Study participants will be administered LY900014 U-100 two times and LY900014 U-200 two times, over 4 study periods, by injection under the skin. Blood samples will be taken to compare how the body handles the study drugs and how they affect the blood sugar levels. Side effects and tolerability will be documented. The study will last about 4 weeks, not including screening and follow up. Screening is required within 28 days prior to the start of the study and follow up is required at least 2 weeks after the last dose of study drug.

Related Clinical Trials

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

A Study of a New LY900014 Formulation in Healthy Participants

NCT02525744

Healthy

COMPLETED PHASE1

A Study of LY900014 Formulation in Healthy Participants

NCT02942654

Healthy

COMPLETED PHASE1

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

NCT02752087

Healthy

COMPLETED PHASE1

A Study of LY900014 Formulations in Healthy Participants

NCT02317575

Healthy Volunteers

COMPLETED PHASE1

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

NCT03232983

Diabetes Mellitus, Type 2

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.

Healthy

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

DOUBLE

Participants Investigators

Study Groups

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

LY900014 U-200

Single subcutaneous (SC) dose of LY900014 U-200 in two of four study periods.

Group Type EXPERIMENTAL

LY900014 U-200

Intervention Type DRUG

Administered SC

LY900014 U-100

Single SC dose of LY900014 U-100 in two of four study periods.

Group Type EXPERIMENTAL

LY900014 U-100

Intervention Type DRUG

Administered SC

Interventions

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

LY900014 U-200

Administered SC

Intervention Type DRUG

LY900014 U-100

Administered SC

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

\- 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
* Have veins suitable for easy blood collection and glucose solution infusion

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

* Had donated blood of more than 450 milliliters (mL) or participated in a clinical trial with similar blood loss within the last 3 months
* Have a regular alcohol intake greater than 21 units/week (male), or 14 units/week (female)
* Smoke more than 10 cigarettes per day
* Are infected with hepatitis B or human immunodeficiency virus (HIV)
* Are taking illegal drugs

Minimum Eligible Age

21 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes