Type 2 Diabetes Mellitus Clinical Trial
Official title:
A Randomized, Double-blind, Parallel-group, Placebo-controlled Study to Assess Efficacy, Safety and Tolerability of Sitagliptin Phosphate 100 mg as Treatment for Recurrent, Persistent or Newly Diagnosed Type 2 Diabetes After Gastric Bypass
The purpose of this study is to assess whether Januvia (sitagliptin phosphate 100mg) is safe and effective for the treatment of Type 2 Diabetes in patients who have had Gastric Bypass.
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.
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