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

MacroGenics0 sites1 target enrollmentAugust 2010

ConditionsType 1 Diabetes Mellitus

Interventionsteplizumab or placebo

Drugsteplizumab or placebo

Overview

Phase: Phase 1
Intervention: teplizumab or placebo
Conditions: Type 1 Diabetes Mellitus
Sponsor: MacroGenics
Enrollment: 1
Primary Endpoint: Dose regimen
Status: Terminated
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

August 2010

End Date

February 2011

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

MacroGenics

Responsible Party

Sponsor

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