NCT02067923

Brief Summary

This study proposes to conduct a non-interventional, multi-center trial that will look at C-peptide results from one or two Mixed Meal Tolerance Tests (MMTT) in participants who received anti-CD3 treatment or placebo on the Abate ITN027AI trial. Anti-CD3 monoclonal antibody is a humanized antibody that is commonly used to prevent organ rejection. It was give in order to determine whether anti-CD3 mAb treatment can halt the progression of newly diagnosed type 1 diabetes. The overall hypothesis of this study is there will be less change in c-peptide levels of the previously treated group versus the control group.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
44

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2014

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

February 1, 2014

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

February 18, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 20, 2014

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 17, 2016

Completed
Last Updated

January 17, 2018

Status Verified

January 1, 2018

Enrollment Period

1.9 years

First QC Date

February 18, 2014

Last Update Submit

January 12, 2018

Conditions

Diabetes Mellitus, Type 1

Keywords

T1Dtype 1 diabetestype 1 diabetes mellitusjuvenile diabetesautoimmune diabetesautoimmuneanti-CD3 mAbmAb hOKT3g1(Ala-Ala)teplizumab

Outcome Measures

Primary Outcomes (1)

  • Mixed Meal Tolerance Test (MMTT) C-peptide levels

    Labs will be obtained to assess beta cell function via c-peptide levels and glucose at 11 time points during the mixed meal tolerance test. Blood samples will be obtained prior to the start of the mixed meal tolerance test to assess auto-antibody status and HbA1c. Approximately 60 cc's of blood will also be obtained for PBMC's and future studies as related to the immunology and genetics of T1DM. A 4 hour urine sample during the MMTT will be collected for C-peptide and Creatinine measurement. We plan to determine the relationship between this measurement and the insulin secretory response.

    1 Study Day

Secondary Outcomes (1)

  • Safety experience

    1 Study Day

Study Arms (2)

Anti-CD3 mAb Plus Diabetes Standard of Care Group

This group of individuals received treatment in the original AbATE study.

Diabetes Standard of Care Group

During the original AbATE study these individuals received standard care.

Eligibility Criteria

Age10 Years - 37 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

The investigators will contact their patients who were originally on the ITN027AI (AbATE) study. Subjects will be contacted via email or phone to see if they would be interested in participating on this Abate follow-up study.

You may qualify if:

  • Prior participation on either the treatment or the control arm of the Abate ITN027AI trial
  • Signed Informed Consent

You may not qualify if:

  • Inability or unwillingness to give informed consent
  • Participation in an investigational treatment trial within the last 6 weeks before enrollment
  • Ongoing major systemic illness.
  • Clinically active serious infections.
  • Any medical condition that in the opinion of the investigator would interfere with safe completion of the trial.
  • Positive pregnancy test in menstruating women
  • Actively breast feeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Church Street Research Unit

New Haven, Connecticut, 06519, United States

Location

Related Publications (1)

  • Perdigoto AL, Preston-Hurlburt P, Clark P, Long SA, Linsley PS, Harris KM, Gitelman SE, Greenbaum CJ, Gottlieb PA, Hagopian W, Woodwyk A, Dziura J, Herold KC; Immune Tolerance Network. Treatment of type 1 diabetes with teplizumab: clinical and immunological follow-up after 7 years from diagnosis. Diabetologia. 2019 Apr;62(4):655-664. doi: 10.1007/s00125-018-4786-9. Epub 2018 Dec 19.

    PMID: 30569273DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

blood urine

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

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

Study Officials

  • Kevan Herold, MD

    Yale University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 18, 2014

First Posted

February 20, 2014

Study Start

February 1, 2014

Primary Completion

January 1, 2016

Study Completion

November 17, 2016

Last Updated

January 17, 2018

Record last verified: 2018-01

Locations

US(1)