Efficacy and safety of teneligliptin, a dipeptidyl peptidase‐4 inhibitor, combined with metformin in Korean patients with type 2 diabetes mellitus: a 16‐week, randomized, double‐blind, placebo‐controlled phase III trial

Abstract

Efficacy and safety of teneligliptin, a dipeptidyl peptidase-4 inhibitor, combined with metformin in Korean patients with type 2 diabetes mellitus: a 16-week, randomized, double-blind, placebo-controlled phase III trialThe aim of the present study was to assess the efficacy and safety of teneligliptin in combination with metformin in Korean patients with type 2 diabetes mellitus who were inadequately controlled with metformin monotherapy. Patients [glycated haemoglobin (HbA1c) 7.0-10.0%, on stable metformin ≥1000 mg/day] were randomized 2 : 1 to receive 20 mg teneligliptin plus metformin (n = 136) or placebo plus metformin (n = 68). The primary endpoint was the change in HbA1c levels from baseline to week 16. The mean baseline HbA1c was 7.9% in the teneligliptin group and 7.8% in the placebo group. The differences between the teneligliptin and placebo groups regarding changes in HbA1c and fasting plasma glucose levels were −0.78 % and −1.24 mmol/l (22.42 mg/dl), respectively, at week 16. The incidence of adverse events was similar between the groups. The addition of teneligliptin once daily to metformin was effective and generally well tolerated in Korean patients with type 2 diabetes.

Efficacy and safety of teneligliptin add-on to insulin monotherapy in Japanese patients with type 2 diabetes mellitus: a 16-week, randomized, double-blind, placebo-controlled trial with an open-label period

“…TNL has been reported to lower HbA1c levels when used alone and in combination therapy [19,22,23]. A similar glycemic-lowering effect was observed when TNL was used in combination with insulin in this study.…”

Investigation of Potential Pharmacokinetic Interactions Between Teneligliptin and Metformin in Steady-state Conditions in Healthy Adults

“…These findings provide further support for the safety and efficacy of using teneligliptin in combination with metformin and suggest that an increase in exposure to metformin is unlikely to increase AEs or cause other clinically relevant problems. 23 Some limitations of the present study warrant mention. In particular, the duration of coadministration was relatively short (3 days), which may limit the emergence of drug-related AEs caused by prolonged exposure to higher concentrations of metformin.…”

Teneligliptin: Heralding Change in Type 2 Diabetes

“…Adverse events with frequency ≥5% included nasopharyngitis, upper respiratory tract inflammation, edema, gastritis, eczema, back pain, blood urine and proteinuria. In Teneligliptin combination study with Metformin [49] involving 204 patients, hypoglycemia was recorded in 2.9% patients receiving Teneligliptin which was similar to placebo.…”