AbATE Follow-Up Study

We propose 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. The first few subjects went on the
trial late in 2005 and the last subjects were enrolled in 2009.The mixed meal tolerance tests
will coincide with approximately 4 years and 6 years post ITN027AI study completion for each
participant. Those participants, who completed the ITN027AI study in 2007 and 2008, will only
have a single MMTT.

We plan to enroll approximately 77 subjects at 5 sites who were previously active with
ITN027AI.. Both the drug treated and the control group participants will be invited to
participate. Along with Yale University these sites include, the University of California-San
Francisco, University of Colorado-Barbara Davis, Benaroya Research Institute, and Pacific
Northwest Research Institute -University of Washington. The investigators of each of these
sites will be asked to contact their patients who were originally on the ITN027AI study.

Subjects will be contacted via email or phone to see if they would be interested in
participating on this Abate follow-up study. Eligible participants will come to the Yale
University Church St. Research Unit or other participating ITN study site for either 1 or 2
mixed meal tolerance tests to determine their current c-peptide status. The available sites
for participants to go to include: Yale University, University of California-San Francisco,
University of Colorado-Barbara Davis Center, Benaroya Research Institute and Pacific
Northwest-University of Washington.

This first visit will consist of the following: an explanation of the study, an assessment of
inclusion/exclusion criteria and documentation of informed consent. If the subject meets the
inclusion/exclusion criteria, a complete medical history will be obtained, physical
examination including vital signs, urine pregnancy test if a female of childbearing potential
and an assessment of concomitant medications. The subject will then have a Mixed Meal
Tolerance Tests (MMTT) with a possible 2nd MMTT with C-Peptide and glucose measurements a
year later based on how long it has been since they were on the ITN027AI Study.The subject
will also have a 4 hour urine collection for C-peptide and creatinine during this MMTT. If a
repeat MMTT is done a year later then another 4 hour urine sample during the MMTT will be
collected for C-peptide and Creatinine measurement.

Inclusion Criteria:

- Prior participation on either the treatment or the control arm of the Abate ITN027AI
trial

- Signed Informed Consent

Exclusion Criteria:

- 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