Comparison of efficacy of add-on therapy of teneligliptin versus pioglitazone among type 2 diabetes mellitus patients ineptly controlled on dual therapy of metformin plus sulfonylurea

Abstract

Aim: The main aim of the study is to compare the efficacy of add-on therapy of teneligliptin (20 once daily) versus pioglitazone (15 mg once daily) among type 2 diabetes mellitus (T2DM) patients inadequately controlled on dual therapy of metformin (MF) plus sulfonylurea (SU). Materials and Methods: It is a prospective, observational, comparative study conducted in patients from the outpatient department of Sri Bhadrakali Hospital located at Warangal, Telangana state, India. The efficacy of pioglitazone and teneligliptin was assessed by measuring the change in the glycated haemoglobin (HbA1c), Fasting Plasma Glucose (FPG), Post Prandial Blood Glucose (PPBH) levels after 12 weeks of treatment. FPG, PPBG and HbA1c levels at baseline and 12 weeks. The primary endpoint was changed in HbA1c levels at 12 weeks as compared to the baseline levels in both groups. The secondary endpoints were changes in FPG, PPBG levels at 12 weeks as compared to baseline levels. Along with, serum cholesterol, triglycerides (TG), high-density lipoprotein (HDL) and low-density lipoprotein (LDL) levels were measured both at baseline and after 12 weeks. Results: At study end, HbA1c levels were reduced from baseline by 0.7% (P = 0.0049) in the pioglitazone group and 1% (P = 0.0002) in the teneligliptin group. The mean changes in FPG levels from baseline to week 12 were −39.8 mg/dl (P ≤ 0.0001) in teneligliptin and −11.48 mg/dl (P = 0.00380) in pioglitazone group. The mean PPG levels from −47.8 mg/dl (P = 0.0003) in teneligliptin and −25.5 mg/dl (P = 0015) in pioglitazone group. After 12 weeks of study, the levels of TG, total cholesterol (TC), LDL −71.5 (P = 0.0973), −15 (P = 0.0501), 18.8 (P ≤ 0.0008) mg/dl and −31.38 (P ≤ 0.0001), −21 (P ≤ 0.0001), −11.68 (P = 0.0028) mg/dl in teneligliptin group and pioglitazone group, respectively. There was significant increase in HDL levels 5.3 (P ≤ 0.0001) mg/dl in teneligliptin group and 5.2 (P = 0.0001) mg/dl in pioglitazone group. Conclusion: Both teneligliptin 20 mg and Pioglitazone 15 mg provided additional HbA1c lowering to that achieved with MF and SU. Teneligliptin showed more effective reductions in HbA1c, FPG, PPBG, HDL and LDL levels. Pioglitazone showed significant changes in HbA1c, HDL, TC, triglyceride levels and significant changes in FPG, PPBG and LDL levels. Reduction in HbA1c and plasma lipids slows down the diabetes progression and decreases the risk of microvascular and macrovascular complications.