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A Study of LY900027 Given by Insulin Pump to Participants With Type 1 Diabetes Mellitus

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Completed
CT.gov ID
NCT04161976
Collaborator
(none)
20
Enrollment
1
Location
2
Arms
6.6
Actual Duration (Months)
3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The main purpose of this study is to learn more about a new formulation of insulin lispro when given by an insulin pump to participants with type 1 diabetes mellitus. The study will investigate how the body processes the drug and how the drug affects the body. Information about side effects will be collected. The study will last from six to 12 weeks for each participant.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Basic Science
Official Title:
A Study to Assess the Pharmacokinetics, Glucodynamics, Safety, and Tolerability of LY900027 in Patients With Type 1 Diabetes Mellitus on Continuous Subcutaneous Insulin Infusion Therapy
Actual Study Start Date :
Dec 27, 2019
Actual Primary Completion Date :
Jul 14, 2020
Actual Study Completion Date :
Jul 14, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: LY900027

LY900027 administered to participants with type 1 diabetes mellitus (T1DM) using continuous subcutaneous insulin infusion (CSII) in one of two dosing periods.

Drug: LY900027
LY900027 administered to participants with T1DM using CSII.
Active Comparator: Insulin Lispro

Insulin lispro administered to participants with T1DM using CSII in one of two dosing periods.

Drug: Insulin Lispro
Insulin lispro administered to participants with T1DM using CSII.
Other Names:
  • Humalog
  • LY275585

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Pharmacokinetics (PK): Pharmacokinetics (PK): Area Under the Insulin Lispro Curve (AUC) 0 to 5 hours after Bolus Administration Prior to a Mixed Meal Tolerance Text (MMTT) [Day 1 through Day 10 in each dosing period]

      PK: AUC after Bolus Administration Prior to a MMTT

    2. PK: Maximum Observed Insulin Lispro Concentration (Cmax) [Day 1 through Day 10 in each dosing period]

      PK: C PK: Cmax

    Secondary Outcome Measures

    1. Pharmacodynamics (PD): Incremental Area Under the Plasma Glucose Curve Above Baseline Between 0-5 hours After Bolus Infusion [Day 1 through Day 10 in each dosing period]

      PD: Incremental Area Under the Plasma Glucose Curve Above Baseline Between 0-5 hours After Bolus Infusion

    2. PD: Total Daily Insulin Dose [Day 1 through Day 10 in each dosing period]

      PD: Total Daily Insulin Dose

    3. Duration Until Catheter Failure [Day -1 through Day 10 in each dosing period]

      Duration Until Catheter Failure

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 64 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Diagnosis of T1DM for at least 1 year

    • Fasting C-peptide ≤0.30 nanomoles per liter (nmol/L)

    • Bbody mass index between 18.5 and 33.0 kilograms per square meter (kg/m²)

    • Participants should have a glycated hemoglobin of ≤9.0% at screening

    Exclusion Criteria:

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Profil Institut für Stoffwechselforschung Neuss Nordrhein-Westfalen Germany 41460

    Sponsors and Collaborators

    • Eli Lilly and Company

    Investigators

    • Study Director: 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), Eli Lilly and Company

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Eli Lilly and Company
    ClinicalTrials.gov Identifier:
    NCT04161976
    Other Study ID Numbers:
    • 17489
    • J2H-MC-IUAA
    • 2019-002318-37
    First Posted:
    Nov 13, 2019
    Last Update Posted:
    Aug 5, 2020
    Last Verified:
    Aug 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:
    Diabetes Mellitus
    Diabetes Mellitus, Type 1
    Insulin Lispro

    Study Results

    No Results Posted as of Aug 5, 2020