Systematic review and meta‑analysis of teneligliptin for treatment of type 2 diabetes

Background and aim There are efcacy and safety concerns related to teneligliptin treatment. A systematic review of randomized controlled trials (RCTs) was undertaken to comprehensively profle the efcacy and safety of teneligliptin in the treatment of type 2 diabetes mellitus (T2DM). Methods Thirteen studies were chosen from a search of scientifc databases for RCTs using teneligliptin as a monotherapy or as an adjunct to other glycemic agents with pre-specifed inclusion criteria. We calculated weighted mean diferences (WMDs) and 95% confdence intervals (CIs) in each included trial and pooled the data using a random-efects model. Results Thirteen studies enrolled 2853 patients were identifed. Teneligliptin treatment was associated with weight gain (vs.placebo, weighted mean diference (WMD) 0.28 kg; 95% CI − 0.20–0.77 kg; I 2=86%; P=0.25). Compared to monotherapy, add on therapy with teneligliptin showed signifcant improvement in FPG mg/dl levels (WMD − 16.75 mg/dl; 95% CI − 19.38 to − 14.13 mg/dl), HOMA-β (WMD 7.91; 95% CI 5.38–10.45) and HOMA-IR (WMD − 0.27; 95% CI − 0.46 to − 0.07). The improvement in HbA1c was greater with monotherapy (WMD − 8.88 mmol/mol; 95% CI − 9.59 to − 8.08 mmol/mol).There was no signifcant risk of any hypoglycemia with teneligliptin compared to placebo (OR 0.84; 95% CI 0.44–1.60; I 2=0%; P=0.60). However, the risk was 1.84 times high when combined with other glycemic agents. The risk of cardiovascular events was comparable, regardless of treatment duration when compared to placebo or any other active comparator (OR 0.79; 95% CI 0.40–1.57; I 2=0%; P=0.50). [PROSPERO, CRD42022360785]. Conclusions Teneligliptin is an efective and safe therapeutic option for patients with T2DM, both as monotherapy and as add-on therapy. However, additional large-scale, high-quality, long-term follow-up clinical trials with diverse ethnic populations are required to confrm its long-term efcacy and safety.