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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01189422
Recruitment Status : Terminated
First Posted : August 26, 2010
Last Update Posted : September 24, 2015
Eli Lilly and Company
Information provided by (Responsible Party):

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
Type 1 Diabetes Mellitus Drug: teplizumab or placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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 : August 2010
Actual Primary Completion Date : February 2011
Actual Study Completion Date : February 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

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

Primary Outcome Measures :
  1. Dose regimen [ Time Frame: 91 days ]
    Define and evaluate dose regimen based on AEs, PD response and drug levels.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
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

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Responsible Party: MacroGenics Identifier: NCT01189422    
Other Study ID Numbers: CP-MGA031-06
First Posted: August 26, 2010    Key Record Dates
Last Update Posted: September 24, 2015
Last Verified: September 2015
Keywords provided by MacroGenics:
Type 1 Diabetes Mellitus
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases