Type 2 diabetes mellitus (T2DM) is a chronic metabolic disorder characterized by progressive
deterioration in the function of the pancreatic beta-cells, which are the cells that produce
and secrete insulin (the hormone primarily responsible for the handling of glucose in the
body). The investigators propose a double-blind, randomized controlled pilot study comparing
the effect of sitagliptin (a novel anti-diabetic drug with beta-cell protective potential)
versus placebo, on the preservation of beta-cell function over one year in patients with T2DM
on metformin, the first-line agent for the treatment of T2DM (ie. the study groups will be
(i) sitagliptin and metformin versus (ii) placebo and metformin). This study may demonstrate
an important beta-cell protective capacity of sitagliptin.
Hypothesis: In patients with T2DM on metformin, treatment with the DPP-IV inhibitor
sitagliptin will preserve pancreatic beta-cell function.
Phase:
Phase 2
Details
Lead Sponsor:
Samuel Lunenfeld Research Institute, Mount Sinai Hospital