A Comparative Study of LY900014 to Insulin Lispro (Humalog) in Healthy Participants

Study Overview
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Brief Summary
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This study compares LY900014, a drug that lowers blood sugar, with insulin lispro (Humalog). Both drugs are given 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 in comparison with insulin lispro. The study will last about 7 to 12 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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A Study to Evaluate the Pharmacokinetics and Glucodynamics of LY900014 and Humalog Across Different Subcutaneous Doses in Healthy Subjects

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: LY900014
* Drug: Insulin Lispro


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 to 30 kilogram per square meter (kg/m²) Have normal blood pressure, pulse rate, electrocardiogram (ECG), blood and urine laboratory test results 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Are currently participating in or completed a clinical trial within the last 30 days Have previously participated or withdrawn from this study Have donated blood or have blood loss of more than 500 mL within the past 3 months

Ages Eligible for Study
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Minimum Age: 18 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LY900014<br>Single dose of 7 units (U), 15 U, and 30 U of LY900014 administered subcutaneously (SC) in three of six periods. | Drug: LY900014<br>* Administered SC<br>* Other names: Ultra-Rapid Lispro;|
| Active Comparator: Insulin Lispro (Humalog)<br>Single dose of 7 U, 15 U, and 30 U of insulin lispro administered SC in three of six periods. | Drug: Insulin Lispro<br>* Administered SC<br>* Other names: Humalog;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics (PK): Insulin Lispro Area Under the Concentration Versus Time Curve (AUC) | Pharmacokinetics: Insulin Lispro Area Under the Concentration Curve From Time Zero to 10 Hours Post Dose [AUC(0-10h)] | Day 1: Pre-dose, 5, 10, 15, 20, 25, 30, 35, 40, 50, 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 |
| --- | --- | --- |
| Glucodynamics: Total Amount of Glucose Infused (Gtot) | Glucodynamics: Total Amount of Glucose Infused (Gtot) Over the Duration of Clamp | Day 1: Every minute starting from the pre-dose and throughout the duration of the clamp until 10 hours post-dose |