Study to Compare 2 Formulations of LY900014 in Healthy Participants

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: LY900014 U-100; Drug: LY900014 U-200

• Registration Number: NCT03616977
• Lead Sponsor: Eli Lilly and Company

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-08-01
• Study First Submitted QC: 2018-08-01
• Study Start: 2018-08-03
• Study First Posted: 2018-08-06
• Primary Completion: 2018-10-19
• Study Completion: 2018-10-19
• Status Verified: 2018-11
• Results First Submitted: 2020-04-20
• Results First Submitted QC: 2020-04-20
• Last Update Submitted: 2020-04-20
• Results First Posted: 2020-04-30
• Last Update Posted: 2020-04-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 69

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
LY900014 U-100	LY900014 U-100	Single SC dose of LY900014 U-100 in two of four study periods.
LY900014 U-200	LY900014 U-200	Single subcutaneous (SC) dose of LY900014 U-200 in two of four study periods.

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics: Insulin Lispro Area Under the Concentration Curve From Time Zero to 10 Hours(h) (AUC [0-10h]) Following Administration of Each Study Arm	Period 1 through 4 Day 1: Predose, 5 minutes(m),10m,15m, 20m, 25m, 30m, 35m, 40m, 45m, 50m, 55m, 60m, 70m, 90m, 120m,150m,180m, 240m, 300m, 360m, 420m, 480m, 540m, and 600m postdose	Pharmacokinetics (PK): Insulin Lispro AUC time zero to 10 hours.

Secondary Outcome Measures

Name	Time	Method
Glucodynamics (GD): Total Amount of Glucose Infused (Gtot) Over Duration of Clamp Following Administration of Each Study Arm	Period 1 through 4 Day 1: Predose, every 10 minutes(m) for 30m prior to dosing; During clamp: every 2.5m for 30m; every 5m for 30 to 120m; every 10m for 120 to 480m, and every 20m for 480m to 600m postdose	GD: Gtot is the total glucose infusion over the clamp duration (10 hours) and is used to measure the study drug action over time as measured by the euglycemic clamp procedure. During the euglycemic clamp procedure, blood glucose concentrations are held constant after the administration of study treatment by adjusting the exogenous glucose infusion rate.

Trial Locations

Locations (1)

Lilly Centre for Clinical Pharmacology; 🇸🇬 Singapore, Singapore