Efficacy and Safety of Lobeglitazone versus Pioglitazone as Add on Therapy to Metformin and Vildagliptin in Patients of Type 2 Diabetes Mellitus: A Randomised Controlled Trial

Introduction: Among the classes of oral anti-hyperglycemic medications that have been developed to date, the thiazolidinedione family is one that primarily regulates insulin resistance.Despite the ongoing discussion concerning the potential adverse effects of thiazolidinedione (TZD) and initiatives to develop new categories of insulin sensitizers, there is still an urgent clinical demand to generate and reinforce evidence on the efficacy and safety of the TZDs.Materials and Method: Lobeglitazone 0.5 mg was administered once daily to patients in group L + M + V as an add-on medication to metformin 1000 mg + vildagliptin 100 mg, whereas pioglitazone 15 mg was administered once daily to patients in group P + M + V and metformin 1000 mg + vildagliptin 100 mg.The decrease in mean HbA1c between baseline and 12 months was the primary outcome.Body weight, incidence of adverse effects, post prandial blood glucose, and fasting blood glucose were the secondary outcome measures.Results: At 6 month and 12 months of follow up, decrease in HbA1c (0.18) was greater in patients receiving lobeglitazone than patients receiving pioglitazone (0.14).At 6 month and 12 months of follow up, there was greater fall in FBG & PPBG in lobeglitazone group than pioglitazone group and the difference was statistically significant (p<0.05).Patients on lobeglitazone experienced a lower frequency of adverse effects. Conclusion:Lobeglitazone was more effective in achieving glycaemic control than pioglitazone in terms of changing the baseline HbA1c concentration without causing any significant side effects.