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Completed

NCT Number: NCT03616977

Study to Compare 2 Formulations of LY900014 in Healthy Participants

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.

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Key information

Conditions

Healthy

Age range

21 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Lilly Centre for Clinical Pharmacology

Singapore, 138623

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LY900014 U-200

Drug

Administered SC

Other names: Ultra-Rapid Lispro

LY900014 U-100

Drug

Administered SC

Other names: Ultra-Rapid Lispro

Primary outcomes

  1. Pharmacokinetics: Insulin Lispro Area Under the Concentration Curve From Time Zero to 10 Hours(h) (AUC [0-10h]) Following Administration of Each Study Arm

    Time frame: 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 outcomes

  1. Glucodynamics (GD): Total Amount of Glucose Infused (Gtot) Over Duration of Clamp Following Administration of Each Study Arm

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

Bioequivalence Study Comparing 2 Formulations of LY900014 in Healthy Subjects

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Aug 6, 2018
Registry last updated
Apr 30, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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