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

Eli Lilly and Company42 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Enrollment

Conditions

Diabetes Mellitus, Type 2

Interventions

LY900014DRUG

Administered SC

Insulin LisproDRUG

Administered SC

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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Are currently participating in or completed a clinical trial within the last 30 days * Have previously participated or withdrawn from this study * Have donated blood or have blood loss of more than 500 mL within the past 3 months

Locations (2)

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician.

Mainz, Germany

Neuss, Germany

Outcomes

Primary Outcomes

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 \[AUC(0-10h)\]

Time frame: 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 Outcomes

Glucodynamics: Total Amount of Glucose Infused (Gtot)

Glucodynamics: Total Amount of Glucose Infused (Gtot) Over the Duration of Clamp

Time frame: Day 1: Every minute starting from the pre-dose and throughout the duration of the clamp until 10 hours post-dose

Data from ClinicalTrials.gov

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