Study to Compare 2 Formulations of LY900014 in Healthy Participants

Lilly

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: LY900014 U-200; Drug: LY900014 U-100

Study type: Interventional

Funder types: Industry

Identifiers

NCT03616977

I8B-MC-ITSS (Other Identifier)

17152

Details and patient eligibility

About

The study involves a comparison of 2 formulations of LY900014, which is a type of fast acting insulin. Study participants will be administered LY900014 U-100 two times and LY900014 U-200 two times, over 4 study periods, by injection under the skin. Blood samples will be taken to compare how the body handles the study drugs and how they affect the blood sugar levels. Side effects and tolerability will be documented. The study will last about 4 weeks, not including screening and follow up. Screening is required within 28 days prior to the start of the study and follow up is required at least 2 weeks after the last dose of study drug.

Enrollment: 69 patients

Sex: All

Ages: 21 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy male or a female (not pregnant and agreeable to take birth control measures until 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 that are acceptable for the study
• Have veins suitable for easy blood collection and glucose solution infusion

Exclusion criteria

• Are currently participating in or completed a clinical trial within the last 30 days or any other type of medical research judged to be incompatible with this study

• Had donated blood of more than 450 milliliters (mL) or participated in a clinical trial with similar blood loss within the last 3 months
• Have a regular alcohol intake greater than 21 units/week (male), or 14 units/week (female)
• Smoke more than 10 cigarettes per day
• Are infected with hepatitis B or human immunodeficiency virus (HIV)
• Are taking illegal drugs

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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69 participants in 2 patient groups

LY900014 U-200

Experimental group

Description:

Single subcutaneous (SC) dose of LY900014 U-200 in two of four study periods.

Treatment:

Drug: LY900014 U-200

LY900014 U-100

Experimental group

Description:

Single SC dose of LY900014 U-100 in two of four study periods.

Treatment:

Drug: LY900014 U-100