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Subcutaneous Administration of Teplizumab in Adults With Type 1 Diabetes (SUBCUE)

Primary Purpose

Type 1 Diabetes Mellitus

Status
Terminated
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
teplizumab or placebo
Sponsored by
MacroGenics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Type 1 Diabetes Mellitus focused on measuring Type 1 Diabetes Mellitus, T1DM

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Randomization after 12 weeks but within 12 months from first doctor visit for symptoms or signs of diabetes
  • Diagnosis of type 1 diabetes mellitus
  • Currently receiving insulin therapy
  • Detectable fasting or stimulated C-peptide level at screening
  • One positive autoantibody test result at screening: Islet-cell autoantibodies (ICA512)/islet antigen-2 (IA-2),Glutamic acid decarboxylase (GAD) autoantibodies, or Insulin autoantibodies

Exclusion Criteria:

  • Any medical condition that, in the opinion of the investigator, would interfere with safe completion of the trial
  • Previous treatment with monoclonal antibody
  • Current treatment with oral antidiabetic agents
  • Evidence of active infection

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Segment 1: 3 Arms

    Segment 2: 4 Arms

    Arm Description

    Outcomes

    Primary Outcome Measures

    Dose regimen
    Define and evaluate dose regimen based on AEs, PD response and drug levels.

    Secondary Outcome Measures

    Full Information

    First Posted
    August 25, 2010
    Last Updated
    February 4, 2022
    Sponsor
    MacroGenics
    Collaborators
    Eli Lilly and Company
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01189422
    Brief Title
    Subcutaneous Administration of Teplizumab in Adults With Type 1 Diabetes
    Acronym
    SUBCUE
    Official Title
    A Phase 1b, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of Subcutaneously Administered Teplizumab (MGA031) in Adults With Type 1 Diabetes Mellitus
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2022
    Overall Recruitment Status
    Terminated
    Study Start Date
    August 2010 (undefined)
    Primary Completion Date
    February 2011 (Actual)
    Study Completion Date
    February 2011 (Actual)

    3. Sponsor/Collaborators

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

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this study is to evaluate the safety, tolerability, pharmacodynamics (PD) and pharmacokinetics (PK) of subcutaneously administered teplizumab in adults with relatively recent onset T1DM, greater than 12 weeks and less than 52 weeks of presentation of first signs and symptoms of disease to a physician prior to randomization.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Type 1 Diabetes Mellitus
    Keywords
    Type 1 Diabetes Mellitus, T1DM

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Phase 1
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    1 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Segment 1: 3 Arms
    Arm Type
    Experimental
    Arm Title
    Segment 2: 4 Arms
    Arm Type
    Experimental
    Intervention Type
    Drug
    Intervention Name(s)
    teplizumab or placebo
    Intervention Description
    infusion or injection
    Primary Outcome Measure Information:
    Title
    Dose regimen
    Description
    Define and evaluate dose regimen based on AEs, PD response and drug levels.
    Time Frame
    91 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    35 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Randomization after 12 weeks but within 12 months from first doctor visit for symptoms or signs of diabetes Diagnosis of type 1 diabetes mellitus Currently receiving insulin therapy Detectable fasting or stimulated C-peptide level at screening One positive autoantibody test result at screening: Islet-cell autoantibodies (ICA512)/islet antigen-2 (IA-2),Glutamic acid decarboxylase (GAD) autoantibodies, or Insulin autoantibodies Exclusion Criteria: Any medical condition that, in the opinion of the investigator, would interfere with safe completion of the trial Previous treatment with monoclonal antibody Current treatment with oral antidiabetic agents Evidence of active infection

    12. IPD Sharing Statement

    Learn more about this trial

    Subcutaneous Administration of Teplizumab in Adults With Type 1 Diabetes

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