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SUBCUE: Subcutaneous Administration of Teplizumab in Adults With Type 1 Diabetes

Sponsor
MacroGenics (Industry)
Overall Status
Terminated
CT.gov ID
NCT01189422
Collaborator
Eli Lilly and Company (Industry)
1
Enrollment
2
Arms
6
Duration (Months)

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: teplizumab or placebo
 Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
1 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Other
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 Start Date :
Aug 1, 2010
Actual Primary Completion Date :
Feb 1, 2011
Actual Study Completion Date :
Feb 1, 2011

Arms and Interventions

Arm Intervention/Treatment
Experimental: Segment 1: 3 Arms

Drug: teplizumab or placebo
infusion or injection
Experimental: Segment 2: 4 Arms

Drug: teplizumab or placebo
infusion or injection

Outcome Measures

Primary Outcome Measures

  1. Dose regimen [91 days]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 35 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • MacroGenics
  • Eli Lilly and Company

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
MacroGenics
ClinicalTrials.gov Identifier:
NCT01189422
Other Study ID Numbers:
  • CP-MGA031-06
First Posted:
Aug 26, 2010
Last Update Posted:
Feb 8, 2022
Last Verified:
Feb 1, 2022
Keywords provided by MacroGenics
Type 1 Diabetes Mellitus
T1DM
Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1

Study Results

No Results Posted as of Feb 8, 2022