Treatment of Diabetes After Gastric Bypass With Sitagliptin

Januvia (sitagliptin phosphate 100mg) is an FDA approved medication for the treatment of Type
2 Diabetes. Sitagliptin works by inhibiting the Dipeptidyl peptidase-4 enzyme, resulting in
increased active glucagon-like peptide-1 (GLP-1) levels. GLP-1 is an incretin which increases
post-prandial insulin secretion. Because Gastric Bypass has also been shown to increase GLP-1
levels, this study seeks to determine the additional effect of DDP-4 inhibition on glucose
control in patients who have elevated incretin levels post Gastric Bypass. The study will
also assess if Januvia (Sitagliptin phosphate) is safe and well tolerated in patients after
Gastric Bypass.

Recruitment and data collection for this study was started at St. Luke's Hospital in New
York, NY and later moved to Columbia University Medical Center in New York, NY.

Inclusion Criteria:

- Must be a resident of the NYC metropolitan area or be able to come for emergency
unscheduled and regular weekly meetings in Manhattan.

- HbA1c ≥ 6.5% and ≤ 8.5 % or a fasting glucose ≥ 126 mg/dL or a random glucose ≥ 200
mg/dL at least 12 months after GBP surgery confirmed by central laboratory.

- Subject is capable and willing to give informed consent.

- Subject is otherwise in good general health, based on medical history and physical
examination.

- Subject is a non smoker for at least 6 months prior to study start

- Female subjects of child bearing potential must use oral, injected or implanted
hormonal methods of contraception from at least the commencement of their last normal
period prior to the first administration of the challenge agent. Subjects using
hormonal contraception should use a barrier method in addition from the first
administration of challenge agent until their next normal period following the end of
the study.

Exclusion Criteria:

- History of type 1 diabetes

- Female subject is pregnant or breastfeeding.

- Recent (< 30 days) or simultaneous participation in another clinical trial.

- Any situation that can compromise the study, including serious illness or a
predictable lack of cooperation from the subject.