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A Study of a New Type of Insulin in Participants With Type 1 Diabetes on Insulin Injection Therapy

Primary Purpose

Diabetes Mellitus, Type 1

Status
Withdrawn
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Insulin Lispro
Sponsored by
Eli Lilly and Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Diabetes Mellitus, Type 1

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Are male or female participants with type 1 diabetes mellitus (T1DM) on a stable multiple daily injection regimen with a short-acting as well as a long-acting insulin
  • Have a body mass index (BMI) ranging from 18.5 to 33.0 kilogram per square meter (kg/m²), inclusive, at screening
  • Have blood pressure, pulse rate, electrocardiogram (ECG), blood and urine laboratory test results 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 enrolled, or have participated within the last 30 days, in a clinical trial or any other type of medical research judged to be incompatible with this study
  • Have previously completed or withdrawn from this study
  • Have or used to have health problems 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
  • Are treated with a continuous subcutaneous insulin infusion (insulin pump)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Active Comparator

    Experimental

    Active Comparator

    Arm Label

    Part A:Insulin Lispro Test

    Part A:Insulin Lispro Reference

    Part B:Insulin Lispro Test

    Part B:Insulin Lispro Reference

    Arm Description

    Individualized doses of Insulin Lispro test formulation administered by injection under the skin once in each of 3 periods

    Individualized doses of Insulin Lispro reference formulation administered by injection under the skin once in each of 3 periods

    Individualized doses of Insulin Lispro test formulation administered by injection under the skin with each meal for 14 days

    Individualized doses of Insulin Lispro reference formulation administered by injection under the skin with each meal for 14 days

    Outcomes

    Primary Outcome Measures

    (Part A) Pharmacokinetics (PK): Area Under the Concentration Curve (AUC) of Insulin Lispro
    (Part A) PK: AUC of Insulin Lispro
    (Part B) PK: AUC of Insulin Lispro
    (Part B) PK: AUC of Insulin Lispro

    Secondary Outcome Measures

    (Part A) Pharmacodynamics (PD): AUC of Glucose Following a Meal
    (Part A) PD: AUC of Glucose Following a Meal
    (Part B) PD: AUC of Glucose Following a Meal
    (Part B) PD: AUC of Glucose Following a Meal

    Full Information

    First Posted
    December 3, 2015
    Last Updated
    July 12, 2017
    Sponsor
    Eli Lilly and Company
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02623452
    Brief Title
    A Study of a New Type of Insulin in Participants With Type 1 Diabetes on Insulin Injection Therapy
    Official Title
    Pharmacokinetics, Glucodynamics, Safety, and Tolerability of a Novel Insulin Lispro Formulation in Patients With Type 1 Diabetes Mellitus on Multiple Daily Insulin Injection Therapy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2017
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Change in clinical strategy
    Study Start Date
    January 2018 (Anticipated)
    Primary Completion Date
    April 2018 (Anticipated)
    Study Completion Date
    April 2018 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Eli Lilly and Company

    4. Oversight

    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
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The study will be conducted in participants with type1 diabetes on insulin injection therapy to investigate how the body processes a test formulation of insulin lispro and the effect of the test formulation on blood sugar levels. Side effects and tolerability will be documented. The study will be conducted in two parts (Part A and Part B) to achieve its objectives. Participants are expected to enroll in both parts.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Diabetes Mellitus, Type 1

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Phase 1
    Interventional Study Model
    Crossover Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Part A:Insulin Lispro Test
    Arm Type
    Experimental
    Arm Description
    Individualized doses of Insulin Lispro test formulation administered by injection under the skin once in each of 3 periods
    Arm Title
    Part A:Insulin Lispro Reference
    Arm Type
    Active Comparator
    Arm Description
    Individualized doses of Insulin Lispro reference formulation administered by injection under the skin once in each of 3 periods
    Arm Title
    Part B:Insulin Lispro Test
    Arm Type
    Experimental
    Arm Description
    Individualized doses of Insulin Lispro test formulation administered by injection under the skin with each meal for 14 days
    Arm Title
    Part B:Insulin Lispro Reference
    Arm Type
    Active Comparator
    Arm Description
    Individualized doses of Insulin Lispro reference formulation administered by injection under the skin with each meal for 14 days
    Intervention Type
    Drug
    Intervention Name(s)
    Insulin Lispro
    Intervention Description
    Administered subcutaneously (SC)
    Primary Outcome Measure Information:
    Title
    (Part A) Pharmacokinetics (PK): Area Under the Concentration Curve (AUC) of Insulin Lispro
    Description
    (Part A) PK: AUC of Insulin Lispro
    Time Frame
    Time 0 to 5 hours post dose for each treatment on Day 1
    Title
    (Part B) PK: AUC of Insulin Lispro
    Description
    (Part B) PK: AUC of Insulin Lispro
    Time Frame
    Time 0 to 5 hours post dose on Day 1 and Day 14 of study treatment
    Secondary Outcome Measure Information:
    Title
    (Part A) Pharmacodynamics (PD): AUC of Glucose Following a Meal
    Description
    (Part A) PD: AUC of Glucose Following a Meal
    Time Frame
    Time 0 to 5 hours post meal for each treatment on Day 1
    Title
    (Part B) PD: AUC of Glucose Following a Meal
    Description
    (Part B) PD: AUC of Glucose Following a Meal
    Time Frame
    Time 0 to 5 hours post meal on Day1 and Day14 of study treatment

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Are male or female participants with type 1 diabetes mellitus (T1DM) on a stable multiple daily injection regimen with a short-acting as well as a long-acting insulin Have a body mass index (BMI) ranging from 18.5 to 33.0 kilogram per square meter (kg/m²), inclusive, at screening Have blood pressure, pulse rate, electrocardiogram (ECG), blood and urine laboratory test results 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 enrolled, or have participated within the last 30 days, in a clinical trial or any other type of medical research judged to be incompatible with this study Have previously completed or withdrawn from this study Have or used to have health problems 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 Are treated with a continuous subcutaneous insulin infusion (insulin pump)
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    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)
    Organizational Affiliation
    Eli Lilly and Company
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    A Study of a New Type of Insulin in Participants With Type 1 Diabetes on Insulin Injection Therapy

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