A prospective multicentre open label study to assess effect of Teneligliptin on glycemic control through parameters of time in range (TIR) Metric using continuous glucose monitoring (TOP-TIR study)

Abstract

Background and aimsContinuous glucose monitoring (CGM) has been effective in assessing glycemic variability in diabetic patients. This study aims at assessing the effect of Teneligliptin using ambulatory glucose profile (AGP) indicators. MethodsA prospective, multicentre, open label study enrolling 59 type 2 diabetes patients between 18 and 65 years age was done between November 2020–May 2021. Patients were administered Teneligliptin 20 mg once daily, in addition to Metformin. The study included pre-treatment and two post-treatment phases. The data on time in range (TIR) and other AGP indicators of glycemic variability were obtained on each patient in all the three study phases and analysed to understand the effect of Teneligliptin on glycemic variability. Safety evaluation was done based on vital and biochemical parameters. ResultsThe percent TIR in post-treatment phase I was significantly higher than the pre-treatment phase (p < 0.0001), and was maintained till the end of phase II (p = 0.037). There was significant lowering of time above range (≥180 mg/dL) in the phase I (p = 0.003), which was maintained in phase II (p = 0.043), suggesting better control over hyperglycemic state. The reduction in mean glucose level in phase I and II was also significant compared to baseline (p = 0.003 and p = 0.023 respectively). The glucose variability percent and glucose management indicator also showed significant lowering in both the phases. ConclusionsTeneligliptin addition to patients uncontrolled on Metformin monotherapy significantly reduced glycemic variability, as well showed significant glycemic improvement. Since this study was a single arm study, a comparative study with other DPP-4 inhibitors is needed.