NCT01189422

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Aug 2010

Shorter than P25 for phase_1

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2010

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

August 25, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 26, 2010

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2011

Completed
Last Updated

February 8, 2022

Status Verified

February 1, 2022

Enrollment Period

6 months

First QC Date

August 25, 2010

Last Update Submit

February 4, 2022

Conditions

Type 1 Diabetes Mellitus

Keywords

Type 1 Diabetes MellitusT1DM

Outcome Measures

Primary Outcomes (1)

  • Dose regimen

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

    91 days

Study Arms (2)

Segment 1: 3 Arms

EXPERIMENTAL
Drug: teplizumab or placebo

Segment 2: 4 Arms

EXPERIMENTAL
Drug: teplizumab or placebo

Interventions

teplizumab or placeboDRUG

infusion or injection

Segment 1: 3 ArmsSegment 2: 4 Arms

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

teplizumab

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 25, 2010

First Posted

August 26, 2010

Study Start

August 1, 2010

Primary Completion

February 1, 2011

Study Completion

February 1, 2011

Last Updated

February 8, 2022

Record last verified: 2022-02