Safety and efficacy of long-term treatment with teneligliptin: Interim analysis of a post-marketing surveillance of more than 10,000 Japanese patients with type 2 diabetes mellitus

Takashi Kadowaki, Masakazu Haneda, Hiroshi Itoh, Makoto Ueno, Miyuki Matsukawa, Tomoko Yamakura, Kazuyo Sasaki, Mayumi Kimura, Hiroaki Iijima

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Background: This post-marketing surveillance examined the safety and efficacy of long-term teneligliptin therapy in Japanese patients. Research design and methods: We report interim results (cut-off date: 28 June 2017) of a 3-year PMS undertaken in subjects with type 2 diabetes mellitus (T2DM). Survey items included demographics, treatments, adverse drug reactions (ADRs), and laboratory variables. A subgroup analysis was also performed across three age groups (<65 years; 65 to <75 years; ≥75 years). Main outcome measures were incidence of ADRs, laboratory variables, and change in glycated hemoglobin (HbA1c) from baseline over time. Results: Of 11,677 patients registered, data from 10,532 patients (6,338 males/4,194 females) were analyzed for the safety analysis set; the median administration period was 731 days. Overall, ADRs and serious ADRs were reported in 364 (3.46%) and 91 patients (0.86%), respectively. The most common ADRs were all hypoglycemia (0.32%), constipation (0.27%), and hepatic function abnormal (0.24%). No change in mean body weight occurred, and a reduction in mean HbA1c was observed until 2 years. The safety and efficacy profiles did not differ markedly among the three age groups. Conclusions: These interim results show that teneligliptin was well tolerated and improved hyperglycemia in Japanese patients with T2DM in clinical practice.

Original languageEnglish
Pages (from-to)83-91
Number of pages9
JournalExpert Opinion on Pharmacotherapy
Issue number2
Publication statusPublished - Jan 22 2018



  • DPP-4 inhibitors
  • elderly
  • Japanese
  • post-marketing surveillance
  • teneligliptin
  • type 2 diabetes mellitus

ASJC Scopus subject areas

  • Pharmacology
  • Pharmacology (medical)

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