A Study to Compare 2 Formulations 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

49 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-04

Study Completion Date

2018-03-15

Brief Summary

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The study involves a comparison of a LY900014 U-200 formulation with a LY900014 U-100 formulation. LY900014 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.

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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

DOUBLE

Participants Investigators

Study Groups

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LY900014-U200

Single subcutaneous (SC) dose of 15 units (U) LY900014 U-200 in two of four study periods

Group Type EXPERIMENTAL

LY900014-U200

Intervention Type DRUG

Administered SC

LY900014-U100

Single SC dose of 15 U LY900014 U-100 in two of four study periods

Group Type EXPERIMENTAL

LY900014-U100

Intervention Type DRUG

Administered SC

Interventions

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LY900014-U200

Administered SC

Intervention Type DRUG

LY900014-U100

Administered SC

Intervention Type DRUG

Other Intervention Names

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Ultra-Rapid Lispro Ultra-Rapid Lispro

Eligibility Criteria

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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
* Have previously participated or withdrawn from this study
* Had blood loss of more than 450 milliliters (mL) 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