Subcutaneous Administration of Teplizumab in Adults With Type 1 Diabetes

Phase 1TerminatedNCT01189422

MacroGenics1 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

QUADRUPLE

Enrollment

Conditions

Type 1 Diabetes Mellitus

Interventions

teplizumab or placeboDRUG

infusion or injection

Eligibility

Sex: ALLMin age: 18 YearsMax age: 35 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Dose regimen

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

Time frame: 91 days

Data from ClinicalTrials.gov

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