Efficacy and Safety of Teneligliptin 40 mg in Type 2 Diabetes: A Pooled Analysis of Two Phase III Clinical Studies.

INTRODUCTION: Teneligliptin, an antihyperglycemic agent belonging to the dipeptidyl peptidase-4 inhibitor class, is usually prescribed at a dose of 20 mg/day. In Japan, the dose can be increased to 40 mg/day if needed. We examined the treatment response when the teneligliptin dose was increased from 20 to 40 mg in a post hoc pooled analysis of data from two 52-week, open-label, phase III clinical trials of teneligliptin 20-40 mg/day as monotherapy or combination treatment in Japanese patients with type 2 diabetes.

METHODS: In both studies, patients received teneligliptin 20 mg for at least 28 weeks; thereafter the dose was increased if glycemic control was inadequate. The data set for this post hoc analysis comprised those patients whose teneligliptin dose was increased to 40 mg at week 28 (N = 204). We assessed (i) the proportion of patients achieving HbA1c reduction after teneligliptin dose increase [≤ - 0.1% change in HbA1c during weeks 28-52 (24 weeks); responders] and (ii) the response to teneligliptin 40 mg according to whether or not patients experienced HbA1c re-elevation (≥ 0.1% increase) during 28 weeks of teneligliptin 20 mg.

RESULTS: Of 204 patients, 108 (52.9%) showed a response to teneligliptin 40 mg (HbA1c change ≤ - 0.1% during weeks 28-52) and had mean (± SD) HbA1c reduction of 0.50 ± 0.44%. Of patients showing re-elevation of HbA1c during treatment with teneligliptin 20 mg, 89/143 (62.2%) achieved HbA1c reduction after dose increase to 40 mg. Logistic regression analyses suggested that change in body weight is one of the parameters linked to HbA1c reduction after dose increase to teneligliptin 40 mg. The incidence of adverse events was not changed after teneligliptin dose increase.

CONCLUSION: Increasing the dosage of teneligliptin from 20 to 40 mg/day has potential as a well-tolerated and effective option for treating type 2 diabetes.

FUNDING: Mitsubishi Tanabe Pharma Corporation.