Safety and efficacy of teneligliptin in Japanese patients with type 2 diabetes mellitus: a pooled analysis of two Phase III clinical studies

Abstract

Objective: To assess the safety and efficacy of long-term administration of teneligliptin alone and in combination with oral antidiabetic drugs in Japanese type 2 diabetes mellitus (T2DM) patients with insufficient glycemic control.

Methods: This post-hoc pooled analysis used data from two Phase III clinical studies involving 702 Japanese patients. We evaluated teneligliptin as monotherapy and combined with a sulfonylurea, glinide, biguanide, or α-glucosidase inhibitor. Safety measures included adverse events (AEs), adverse reactions and hypoglycemia. The main efficacy measure was the change in glycated hemoglobin (HbA_1c) from baseline.

Results: Incidences of AEs and adverse reactions were similar among the teneligliptin monotherapy group and all combination therapy groups except the combination with sulfonylurea. Hypoglycemia was more frequent in the sulfonylurea combination therapy group than in other groups. Teneligliptin administered once daily as monotherapy or combination therapy resulted in a decrease in HbA_1c, which was maintained for 52 weeks. Bodyweight showed no change or a slight increase at the end of 52 weeks in all groups.

Conclusions: This pooled analysis provides evidence for the safety and efficacy of long-term use of teneligliptin as monotherapy or combination therapy in Japanese T2DM patients.

Keywords:

• co-administration
• Japanese
• Phase III
• pooled analysis
• teneligliptin
• type 2 diabetes

Acknowledgement

The authors wish to thank all of the investigators and institutions involved in this study, a list for which is provided in the Appendix.

Author contributions

T Kadowaki supervised the design and protocol of the study, and contributed to the interpretation and discussion of the results. F Marubayashi contributed to the development of the protocol and the design, and prepared the data. S. Yokota contributed to the data processing and statistical analysis. M Katoh and H Iijima contributed to the preparation of the outline of the paper, and the interpretation and discussion of the data. All authors contributed to manuscript preparation and have approved the final draft.

Declaration of interest

T Kadowaki was the independent medical adviser for this study and is on the Advisory Panel of Daiichi Sankyo Co., Ltd., Mitsubishi Tanabe Pharma Corporation, Nippon Boehringer Ingelheim Co., Ltd., Novo Nordisk Pharma Ltd., Taisho Pharmaceutical Co., Ltd. and Takeda Pharmaceutical Co., Ltd.; has received consulting fees from MSD K.K. and Nippon Boehringer Ingelheim Co., Ltd.; has received research support from AstraZeneca K.K., Chugai Pharmaceutical Co., Ltd., Daiichi Sankyo Co., Ltd., Mitsubishi Tanabe Pharma Corporation, MSD K.K., Ono Pharmaceutical Co., Ltd., Sanofi K.K. and Takeda Pharmaceutical Co., Ltd.; and is on speakers bureaus for Astellas Pharma Inc., AstraZeneca K.K., Daiichi Sankyo Co., Ltd., Eli Lilly Japan K.K., Kowa Company, Ltd., Kyowa Hakko Kirin Co., Ltd., Mitsubishi Tanabe Pharma Corporation, MSD K.K., Nippon Boehringer Ingelheim Co., Ltd., Novartis Pharma K.K., Ono Pharmaceutical Co., Ltd., Sanofi K.K., Sanwa Kagaku Kenkyusho Co., Ltd., Sumitomo Dainippon Pharma Co., Ltd., Taisho Pharmaceutical Co., Ltd. and Takeda Pharmaceutical Co., Ltd. All other authors are employees of Mitsubishi Tanabe Pharma Corporation. This study was funded by Mitsubishi Tanabe Pharma Corporation, Tokyo, Japan. Medical writing support was provided by Helen Roberton and Nicholas Smith, PhD from Edanz Group Ltd and was funded by Mitsubishi Tanabe Pharma Corporation. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

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