Teneligliptin versus sitagliptin in Korean patients with type 2 diabetes inadequately controlled with metformin and glimepiride: A randomized, double-blind, non-inferiority trial

Yonghyun Kim, Eun Seok Kang, Hak Chul Jang, Dong Jun Kim, Taekeun Oh, Eun Sook Kim, Nan Hee Kim, Kyung Mook Choi, Sung Rae Kim, Ji Young You, Se Jin Kim, Moon Kyu Lee

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    11 Citations (Scopus)

    Abstract

    Aim: To assess the efficacy and safety of add-on therapy with the dipeptidyl peptidase-4 inhibitor teneligliptin compared with sitagliptin in patients with type 2 diabetes (T2DM) inadequately controlled with metformin and glimepiride. Materials and Methods: This was a phase 3, randomized, double-blind, non-inferiority study of adult Korean subjects with T2DM (n = 201), with HbA1c ranging from 7.0% to 11.0%, on stable doses of metformin plus glimepiride. Subjects were randomized in a 1:1 fashion to receive either oral teneligliptin 20 mg or sitagliptin 100 mg for 24 weeks. The primary endpoint was change from baseline in HbA1c. Results: At baseline, mean age was 60.56 ± 9.41 years, body mass index was 25.23 ± 2.85 kg/m2 and HbA1c was 8.11% ± 0.79%. At 24 weeks, both groups achieved significant reductions from baseline in HbA1c (teneligliptin, −1.03% ± 0.10% [P < 0.0001]; sitagliptin, −1.02% ± 0.10% [P < 0.0001]). The inter-group difference was −0.01% (95% confidence interval [CI]: −0.28, 0.26; P = 0.9497); the upper limit of the 95% CI was within the preset limit for non-inferiority (0.4%). There were no significant differences between groups in the proportion of patients achieving HbA1c targets, or changes from baseline in fasting plasma glucose, body weight or lipid levels at 24 weeks. Rates of adverse events (teneligliptin, n = 63 [61.76%]; sitagliptin, n = 61 [62.24%]; P = 0.9442) and hypoglycaemia (teneligliptin, n = 32 [31.37%]; sitagliptin, n = 28 [28.57%]; P = 0.6656) were similar. Conclusion: Teneligliptin was non-inferior to sitagliptin in the context of triple therapy for T2DM and is an important option in this setting.

    Original languageEnglish
    Pages (from-to)631-639
    Number of pages9
    JournalDiabetes, Obesity and Metabolism
    Volume21
    Issue number3
    DOIs
    Publication statusPublished - 2019 Mar

    Bibliographical note

    Funding Information:
    information This study was supported by Handok Inc., Seoul, Republic of Korea.Weber Shandwick Hong Kong is acknowledged for editorial support in manuscript preparation. We thank the other investigators for their cooperation with this study. The full list of investigators for this study is: Hyoung Woo Lee (Yeungnam University Medical Center, Daegu, Korea), Sang Ah Lee (Jeju National University Hospital, Jeju, Korea), Ho Chan Cho (Keimyung University Dongsan Medical Center, Daegu, Korea), Kang Seo Park (Eulji University Hospital, Daejeon, Korea), Bon Jeong Ku (Chungnam National University Hospital, Daejeon, Korea), Eun Young Lee (Seoul St. Mary's Hospital, The Catholic University of Korea, Seoul, Korea), Young Min Cho (Seoul National University Hospital, Seoul, Korea), Byung-Joon Kim (Gachon University Gil Medical Center, Incheon, Korea), Chung Gu Cho (Wonkwang University Hospital, Iksan, Korea), In Joo Kim (Pusan National University Hospital, Pusan, Korea), Young Sik Choi (Kosin University Gospel Hospital, Pusan, Korea), and Seongbin Hong (Inha University Hospital, Incheon, Korea).

    Publisher Copyright:
    © 2018 The Authors. Diabetes, Obesity and Metabolism published by John Wiley & Sons Ltd.

    Keywords

    • DPP-4 inhibitor
    • sitagliptin
    • teneligliptin
    • triple therapy
    • type 2 diabetes

    ASJC Scopus subject areas

    • Internal Medicine
    • Endocrinology, Diabetes and Metabolism
    • Endocrinology

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