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

Lilly

Status and phase: Completed; Phase 1

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: LY900014 (IV); Drug: LY900014 (SC)

Study type: Interventional

Funder types: Industry

Identifiers

NCT03232983

16639

I8B-MC-ITRT (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 28 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 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• Have previously participated or withdrawn from this study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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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28 participants in 4 patient groups

LY900014 (SC Abdomen)

Experimental group

Description:

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

Treatment:

Drug: LY900014 (SC)

LY900014 (SC Thigh)

Experimental group

Description:

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

Treatment:

Drug: LY900014 (SC)

LY900014 (SC Arm)

Experimental group

Description:

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

Treatment:

Drug: LY900014 (SC)

LY900014 (IV)

Active Comparator group

Description:

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

Treatment:

Drug: LY900014 (IV)