A Study of LY900014 in Healthy Chinese Participants

Study Overview
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Brief Summary
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The purpose of this study is to evaluate a new formulation of insulin lispro, LY900014, which is a drug that lowers blood sugar. The study will look at how the body processes LY900014 and the effect of LY900014 on blood sugar levels. For each participant, the study will consist of 3 periods and will last about 51 days.

Official Title
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A Study to Evaluate the Pharmacokinetics and Glucodynamics of LY900014 Following Single Dose Administration in Healthy Chinese Subjects

Conditions
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Healthy

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: Are overtly healthy native Chinese males or females Female participants: Women of child-bearing potential who are abstinent or use effective methods of contraception for the entirety of the study. Women not of child-bearing potential who are infertile or post-menopausal Have a body mass index (BMI) of 18 to 28 kilograms per square meter (kg/m²) Are nonsmokers Have a fasting plasma glucose value >71 milligrams per deciliter (mg/dL) (3.9 millimoles per liter [mmol/L]) and <108 mg/dL (6.0 mmol/L) Exclusion Criteria: Are currently enrolled in a clinical study, or have participated, within the last 30 days, in a clinical study involving an investigational product Have previously completed or withdrawn from this study or any other study investigating LY900014 Have known allergies to LY900014 or any components of the formulation Have a significant history of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the investigational product; or of interfering with the interpretation of data Intend to use over-the-counter or prescription medication within 7 and 14 days, respectively, prior to dosing or during the study. Have donated blood of more than 400 milliliters (mL) within the previous 6 months of study screening or donated more than 100 mL within the last 30 days. Have an average weekly alcohol intake that exceeds 21 units per week (males) and 14 units per week (females)

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Insulin Lispro (Humalog)<br>15 units (U) Insulin Lispro (Humalog) administered once, subcutaneously (SC), in one of three study periods. | Drug: Insulin Lispro<br>* Administered SC<br>* Other names: Humalog;|
| Experimental: LY900014<br>7 U, and 15 U LY900014 administered once, SC, in two of three study periods. | Drug: LY900014<br>* Administered SC<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 (PK): Insulin Lispro Area Under the Serum Concentration Versus Time Curve From Time Zero to 10 Hours Postdose (AUC[0-10h]) | PK: Insulin Lispro AUC(0-10h) | Day 1: Predose, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 70, 90, 120, 150, 180, 240, 300, 360, 420, 480, 540, and 600 minutes postdose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacodynamics (PD): Total Amount of Glucose Infused (Gtot) | Gtot is the total amount of glucose infused over the duration of the clamp procedure (10 hours) for each study period. | Day 1: Predose: -10, -20, -30 minutes; During clamp: every 2.5 to 3 minutes for the first 30 minutes; every 5 minutes for 30 to 120 minutes; every 10 minutes for 120 to 480 minutes and every 20 minutes for 480 to 600 minutes postdose |