A Study of LY900014 in Healthy Chinese Participants

Phase 1

Completed

Brief Summary: 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.

Recruitment & Eligibility

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Have previously completed or withdrawn from this study or any other study investigating LY900014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)

Arm && Interventions

Group	Intervention	Description
LY900014	LY900014	7 U, and 15 U LY900014 administered once, SC, in two of three study periods.
Insulin Lispro (Humalog)	Insulin Lispro	15 units (U) Insulin Lispro (Humalog) administered once, subcutaneously (SC), in one of three study periods.

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics (PK): Insulin Lispro Area Under the Serum Concentration Versus Time Curve From Time Zero to 10 Hours Postdose (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	PK: Insulin Lispro AUC(0-10h)

Secondary Outcome Measures

Name	Time	Method
Pharmacodynamics (PD): Total Amount of Glucose Infused (Gtot)	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	Gtot is the total amount of glucose infused over the duration of the clamp procedure (10 hours) for each study period.