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

Study Overview
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Brief Summary
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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.

Official Title
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Effect of Injection Site on the Relative and Absolute Bioavailability of Single Dose of LY900014 in Healthy Subjects

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: LY900014 (SC)
* Drug: LY900014 (IV)


Participation Criteria
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Eligibility Criteria
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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30 days or any other type of medical research judged to be incompatible with this study Have previously participated or withdrawn from this study Had blood loss of more than 450 milliliters (mL) within the last 3 months

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LY900014 (SC Abdomen)<br>Single dose of 15-U of LY900014 administered subcutaneously (SC) into the abdomen in one period | Drug: LY900014 (SC)<br>* Administered SC<br>* Other names: Ultra-Rapid Lispro;|
| Experimental: LY900014 (SC Thigh)<br>Single dose of 15-U of LY900014 administered SC into the thigh in one period | Drug: LY900014 (SC)<br>* Administered SC<br>* Other names: Ultra-Rapid Lispro;|
| Experimental: LY900014 (SC Arm)<br>Single dose of 15-U of LY900014 administered SC into the arm (deltoid) in one period | Drug: LY900014 (SC)<br>* Administered SC<br>* Other names: Ultra-Rapid Lispro;|
| Active Comparator: LY900014 (IV)<br>Single dose of 15-U of LY900014 administered intravenously (IV) in one period | Drug: LY900014 (IV)<br>* Administered IV<br>* Other names: Ultra-Rapid Lispro;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics: Insulin Lispro Area Under the Concentration Versus Time Curve (AUC) Following LY900014 Administration | Pharmacokinetics(PK): Insulin lispro AUC from time zero to 10 hours post dose [AUC(0-10h)]. | Day 1: Pre-dose, 2.5, 5, 10, 15, 20, 25, 30, 40, 60, 70, 90, 120, 150, 180, 210, 240, 300, 360, 420, 480, 540, and 600 minutes post-dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Amount of Glucose Infused (Gtot) Over Duration of the Clamp Procedure | Glucodynamics: Gtot is the total glucose infusion over the clamp duration (10 hours) and is used to measure the study drug action over time as measured by the euglycemic clamp procedure. During the euglycemic clamp procedure, blood glucose concentrations are held constant after the administration of LY900014 by adjusting the exogenous glucose infusion rate. | Every 10 minutes for 30 minutes predose, every 2.5 minutes for 30 minutes, then every 5 minutes for 120 minutes, then every 10 minutes for 120 to 480 minutes and every 10 minutes for 480 to 600 minutes post-dose |