Clinical Trial of Additive Action of Vildagliptin to Insulin Therapy in Improving Glycemic Control in type 2 Diabetes Mellitus with Reduced Events of Hypoglycemia

摘要

Objectives : To study the efficacy and tolerability of Vildagliptin added to insulin therapy in patients with type 2 diabetes mellitus and to assess the events of severe hypoglycemia. Methods : One forty four (n=144) uncontrolled type 2 diabetic patients continuing insulin therapy were put on Vildagliptin (50mg/twice daily) for twenty four weeks and one hundred and fifty two (n=152) patients of uncontrolled type 2 diabetic continuing insulin therapy were put on placebo for twenty four weeks to assess the efficacy of Vildagliptin and events of severe hypoglycemia. Results : Baseline HbA1c averaged 8.4+0.1% in both groups. The adjusted mean change from baseline to end point in HbAic was - 0.5±0.1% and - 0.2±0.1% in patients receiving Vildagliptin and placebo respectively. The difference Was significant between the two groups (p=0.01). The incidence of adverse events was almost similar in Vildagliption (81.5%) and placebo (82.9%) groups. However, hypoglymic events were less common (p<0.001) and less severe (p<0.05) in patients receiving Vildagliptin than in those receiving placebo. Conclusion : Vildagliptin decreases HbA1 с in patients whose type 2 diabetes is poorly controlled with high dose of insulin. Addition of Vildagliptin to insulin therapy is also associated with reduced confirmed and severe hypoglycemic events.