Assessment of safety of Saxagliptin in patients of type 2 diabetes mellitus who were previously on metformin monotherapy with uncontrolled diabetes

Abstract

Introduction: Dipeptidyl peptidase-4 are a relatively new class of oral antihyperglycemic agent that enhance insulin secretion by reducing degradation of endogenous glucagon-like peptide 1. Currently, sitagliptin, vildagliptin, saxagliptin, linagliptin and alogliptin are approved in India, USA and Europe for the use in patients with type 2 diabetes. In this study we have tried to assess the safety of saxagliptin used in patients of type 2 DM who were previously on metformin monotherapy. Materials and Methods: A total of 35 patients who were previously on metformin montherapy with uncontrolled diabetes were enrolled. Patients were started with saxagliptin (2.5 mg OD) and were followed up at 1st, 3rd and 6th months for the estimation of Liver Function Test (SGOT, SGPT, Bilirubin direct & indirect), Renal Function Test (BUN and Sr. Creatinine). During the follow up period patients were also assessed for the adverse drug reactions. Results: Male and female patients mean age SD (61.42 yrs 6.99 and 55.93 yrs 5.74 respectively). The mean significant decrease in values from baseline at 24 weeks were seen for SGOT, SGPT, Blood urea nitrogen and serum creatinine. Conclusion: The combination of saxagliptin plus metformin for the treatment of type 2 diabetes offers an oral treatment regimen that is safe and well tolerated. Keywords: Saxagliptin, Uncontrolled type 2DM safety knee arthralgia.