A Study of LY900014 Formulation in Participants With Type 1 Diabetes Mellitus Using Insulin Pumps

Overview

This study evaluated a blood sugar lowering insulin, LY900014, delivered by an insulin pump continuously under the skin. The study was conducted in participants with type 1 diabetes mellitus to investigate how the human body processed LY900014 and its effect on blood sugar levels when it was delivered via an insulin pump. Side effects and tolerability were be documented.

Full Title of Study: “Pharmacokinetics, Glucodynamics, Safety, and Tolerability of LY900014 in Patients With Type 1 Diabetes Mellitus on Continuous Subcutaneous Insulin Infusion Therapy”

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: August 2016

Interventions

  • Drug: LY900014
    • Administered subcutaneously (SC)
  • Drug: Insulin Lispro
    • Administered SC

Arms, Groups and Cohorts

  • Experimental: LY900014
    • LY900014 delivered via an insulin pump as a continuous infusion under the skin with intermittent bolus doses during meals for two 3-day periods
  • Active Comparator: Insulin Lispro
    • Insulin lispro delivered via an insulin pump as a continuous infusion under the skin with intermittent bolus doses during meals for two 3-day periods

Clinical Trial Outcome Measures

Primary Measures

  • Pharmacokinetics (PK): Insulin Lispro Area Under the Concentration Curve From Time Zero to 5 Hours (AUC[0-5h])
    • Time Frame: Days 1 and 3: -15, 0, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 70, 90, 120, 150, 180, 240, 300 minutes post dose for each treatment
    • PK: Insulin Lispro AUC(0-5h)

Secondary Measures

  • Pharmacodynamics (PD): Area Under the Concentration Curve From Time Zero to 5 Hours (AUC[0-5h]) of Glucose Relative to a Mixed Meal Tolerance Test (MMTT)
    • Time Frame: Days 1 and 3: -30, -15, 0, 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120, 135, 150, 165, 180, 195, 210, 225, 240, 300 minutes post dose for each treatment
    • PD: AUC(0-5h) of Glucose Relative to a Mixed Meal Tolerance Test (MMTT)

Participating in This Clinical Trial

Inclusion Criteria

  • Male or female participants with Type 1 Diabetes Mellitus (T1DM) who are receiving insulin therapy via an approved insulin pump – Have a body mass index (BMI) of 18.5 to 33 kilogram per square meter (kg/m²), inclusive, at screening – Have blood pressure, pulse rate, electrocardiogram (ECG), blood and urine laboratory test results that are acceptable for the study – Have had no episodes of severe hypoglycemia in the past 6 months (requiring assistance in treatment by a second party) – Have venous access sufficient to allow for blood sampling – Have provided written consent and are willing to follow study procedures and commit to the study duration Exclusion Criteria:

  • Are currently participating in or completed a clinical trial within the last 30 days from a clinical trial or any other type of medical research judged to be incompatible with this study – Have previously participated or withdrawn from this study – Have or used to have health problems, laboratory test results, blood pressure or ECG readings that, in the opinion of the doctor, could make it unsafe to participate in the study – Had blood loss of more than 500 milliliters (mL) within the last month

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

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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