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

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.

Full Title of Study: “A Study to Evaluate the Pharmacokinetics and Glucodynamics of LY900014 and Humalog Across Different Subcutaneous Doses in Healthy Subjects”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Basic Science
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: February 6, 2018

Interventions

  • Drug: LY900014
    • Administered SC
  • Drug: Insulin Lispro
    • Administered SC

Arms, Groups and Cohorts

  • Experimental: LY900014
    • Single dose of 7 units (U), 15 U, and 30 U of LY900014 administered subcutaneously (SC) in three of six periods.
  • Active Comparator: Insulin Lispro (Humalog)
    • Single dose of 7 U, 15 U, and 30 U of insulin lispro administered SC in three of six periods.

Clinical Trial Outcome Measures

Primary Measures

  • Pharmacokinetics (PK): Insulin Lispro Area Under the Concentration Versus Time Curve (AUC)
    • 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
    • Pharmacokinetics: Insulin Lispro Area Under the Concentration Curve From Time Zero to 10 Hours Post Dose [AUC(0-10h)]

Secondary Measures

  • Glucodynamics: Total Amount of Glucose Infused (Gtot)
    • Time Frame: Day 1: Every minute starting from the pre-dose and throughout the duration of the clamp until 10 hours post-dose
    • Glucodynamics: Total Amount of Glucose Infused (Gtot) Over the Duration of Clamp

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Eli Lilly and Company
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon – Fri 9 AM – 5 PM Eastern time (UTC/GMT – 5 hours, EST), Study Director, Eli Lilly and Company

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