A Study of a New LY900014 Formulation in Healthy Participants

Lilly

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Insulin Lispro (Humalog); Drug: LY900014

Study type: Interventional

Funder types: Industry

Identifiers

NCT02525744

I8B-FW-ITRE (Other Identifier)

15989

Details and patient eligibility

About

This study evaluates a new formulation of LY900014, a drug that lowers blood sugar. It is administered by injection under the skin of the abdomen. The study will be conducted in healthy people to investigate how quickly and how much LY900014 is absorbed and the effect of different doses of LY900014 on blood sugar levels. Side effects and tolerability will be documented. The study will last for about 8 to 9 weeks for each participant, including screening and follow up. Screening is required within 28 days prior to entering the study.

Enrollment: 24 patients

Sex: All

Ages: 21 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Overtly healthy male or a female (not pregnant and agreeable to take birth control measures until one month after study completion)
• Have a body mass index (BMI) of 18.5 to 30 kilogram per square meter (kg/m^2), inclusive, at screening
• 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 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

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• Have previously participated or withdrawn from this study
• Have or used to have health problems or laboratory test results or ECG readings that, in the opinion of the doctor, could make it unsafe to participate, or could interfere with understanding the results of the study

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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24 participants in 4 patient groups

LY900014 7.5 Units (U)

Experimental group

Description:

Single dose of 7.5 U LY900014 administered subcutaneously (SC) in one to two of five periods.

Treatment:

Drug: LY900014

Insulin Lispro

Active Comparator group

Description:

Reference formulation. Single dose of Insulin Lispro administered SC in one to two of five periods.

Treatment:

Drug: Insulin Lispro (Humalog)

LY900014 15 U

Experimental group

Description:

Single dose of 15 U LY900014 administered subcutaneously (SC) in one to two of five periods.

Treatment:

Drug: LY900014

LY900014 30 U

Experimental group

Description:

Single dose of 30 U LY900014 administered subcutaneously (SC) in one to two of five periods.

Treatment:

Drug: LY900014