Comparison of efficacy and safety of teneligliptin and glimepiride as add-on to metformin in ameliorating glycaemic variability based on professional continuous glucose monitoring data in patients with type 2 diabetes mellitus

Background: Glycemic variability takes into account the intraday glycemic excursions including episodes of hyper and hypoglycaemia. This study was planned to compare effects of teneligliptin and glimepiride as add-on to metformin on glycemic variability in Indian patients with uncontrolled type 2 diabetes mellitus (T2DM). Methods: This was a prospective, randomized, open-label, multi-centre study in 52 T2DM patients uncontrolled on optimal metformin dose (HbA1c 7.0%-9.5%). They were randomised in 1:1 ratio to teneligliptin 20 mg once daily (T/M group) or glimepiride(G/M group) as an add-on to metformin and were deployed with a professional continuous glucose monitoring (iCGM) device for 14 consecutive days. The endpoints measured were 24 hours mean glucose level, proportion of time in euglycemia (>70 - <180 mg/dL), hyperglycemia (>180 mg/dL), and hypoglycaemia (< 70 mg/dL). Results: Significantly higher proportion of time was spent in hypoglycemia in G/M group compared to T/M group (10.04% vs 03.4%; p = 0.04). Proportion of time spent in euglycemia and hyperglycemia was comparable between the groups. There was greater reduction in PPG from baseline at Day 14 in T/M group (-27.16  64.30 mg/dL) compared to G/M group (-7.19 78.45mg/dL, p = 0.53). Conclusion: Teneligliptin as add-on to metformin offers low intraday glycemic variability, allowing more predictable glycemic control as compared to glimepiride and emerges as a safe, tolerable and effective treatment in patients with T2DM on more stringent criteria of glycemic variability.