Sustained Efficacy and Reduced Hypoglycemia during One Year of Treatment with Vildagliptin Added to Insulin in Patients with Type 2 Diabetes Mellitus

Introduction Vildagliptin is a potent and selective inhibitor of the enzyme dipeptidyl peptidase-4 (DPP-4), which enhances endogenous glucagon-like peptide-1 (GLP-1) levels and improves islet function by increasing both α- and β-cell responsiveness to glucose [ 1 ] [ 2 ]. Vildagliptin produced statistically significant and clinically meaningful reductions in HbA1c values when given as monotherapy in drug-naïve patients [ 3 ] [ 4 ] or in combination with metformin [ 5 ] and pioglitazone [ 6 ], without weight gain and with minimal hypoglycemia. In patients with a long history of diabetes requiring insulin therapy, a population notoriously difficult to treat because therapeutic options are limited, the addition of vildagliptin to insulin therapy was associated with improved glycemic control and less hypoglycemia after six months of treatment [ 7 ]. The present study represents a report of longer-term data from this recently reported clinical trial, undertaken to assess the efficacy and safety of vildagliptin therapy over one year in patients with long-standing type 2 diabetes mellitus (T2DM) that was inadequately controlled by insulin therapy. 1 The trial (NCT00138606) described here is registered with ClinicalTrials.gov.