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

Lilly

Status and phase: Completed; Phase 1

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: Insulin Lispro; Drug: LY900014

Study type: Interventional

Funder types: Industry

Identifiers

NCT03286751

2017-001859-32 (EudraCT Number)

I8B-MC-ITSH (Other Identifier)

16898

Details and patient eligibility

About

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.

Enrollment: 42 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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• Have previously participated or withdrawn from this study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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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42 participants in 2 patient groups

LY900014

Experimental group

Description:

Single dose of 7 units (U), 15 U, and 30 U of LY900014 administered subcutaneously (SC) in three of six periods.

Treatment:

Drug: LY900014

Insulin Lispro (Humalog)

Active Comparator group

Description:

Single dose of 7 U, 15 U, and 30 U of insulin lispro administered SC in three of six periods.

Treatment:

Drug: Insulin Lispro