Subcutaneous Administration of Teplizumab in Adults With Type 1 Diabetes

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-08-31

Study Completion Date

2011-02-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Type 1 Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Segment 1: 3 Arms

Group Type EXPERIMENTAL

teplizumab or placebo

Intervention Type DRUG

infusion or injection

Segment 2: 4 Arms

Group Type EXPERIMENTAL

teplizumab or placebo

Intervention Type DRUG

infusion or injection

Interventions

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teplizumab or placebo

infusion or injection

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No