A Study of LY900014 Formulation in Healthy Participants

Lilly

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: LY900014; Drug: Insulin Lispro

Study type: Interventional

Funder types: Industry

Identifiers

NCT02942654

I8B-MC-ITRL (Other Identifier)

16170

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 about 6 to 7 weeks for each participant, including screening and follow up. Screening is required within 28 days prior to entering the study.

Enrollment: 32 patients

Sex: All

Ages: 21 to 70 years old

Volunteers: Accepts Healthy Volunteers

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), 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• Have previously participated or withdrawn from this study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
• Had blood loss of more than 450 milliliters (mL) within the last month

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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32 participants in 2 patient groups

LY900014

Experimental group

Description:

Test formulation. 15-U dose of LY900014 administered subcutaneously (SC) in one of two periods.

Treatment:

Drug: LY900014

Insulin Lispro

Active Comparator group

Description:

Reference formulation. 15-U dose of Insulin Lispro administered SC in one of two periods.

Treatment:

Drug: Insulin Lispro