Type 2 Diabetes Mellitus Clinical Trial
Official title:
A Randomized Controlled Pilot Study Assessing the Effect of Sitagliptin on the Preservation of Beta-Cell Function in Patients With Type 2 Diabetes
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.
Medications currently used in the treatment of T2DM have not been shown to modify the progressive decline in beta-cell function that occurs over time. Recent evidence, however, suggests that a new class of anti-diabetic medications, called dipeptidyl peptidase-IV (DPP-IV) inhibitors, may be able to protect beta cells and hence alter the natural history of T2DM. We thus wish to study the effect of sitagliptin (a DPP-IV inhibitor) on the preservation of beta-cell function in patients with T2DM randomized to either (i) sitagliptin and metformin or (ii) placebo and metformin. ;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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