Efficacy and safety of the dipeptidyl peptidase-4 inhibitor sitagliptin compared with α-glucosidase inhibitor in Japanese patients with type 2 diabetes inadequately controlled on sulfonylurea alone (SUCCESS-2): A multicenter, randomized, open-label, non-inferiority trial

K. Kobayashi, H. Yokoh, Y. Sato, M. Takemoto, D. Uchida, A. Kanatsuka, N. Kuribayashi, T. Terano, N. Hashimoto, K. Sakurai, H. Hanaoka, K. Ishikawa, S. Onishi, K. Yokote, Tokuyoshi An, Hirotake Tokuyama, Hideaki Bujo, Harukiyo Kawamura, Takahisa Shibata, Ichiro TatsunoTakayuki Ishibashi, Susumu Nakamura, Keiji Mikami, Kazuo Yamamoto, Kenichi Yamada, Yusuke Hirota, Naoko Tadokoro, Takahiko Tokuyama, Ryoichi Ishibashi, Shin Nakamura, Jun Tashiro, Kyohei Yamamoto, Toshiaki Ban, Rie Sano, Hiroko Ito, Tomoaki Tanaka, Sawako Nishimura, Keiko Saito, Motonobu Nishimura, Masami Fuse, Masahiro Mimura, Sawako Suzuki, Kaori Tachibana, Masahiko Yamada, Takahiro Ishikawa, Miwako Nakamura, Tsuyoshi Oji, Masaki Fujimoto

Research output: Contribution to journalArticle

10 Citations (Scopus)

Abstract

We assessed the efficacy and safety of sitagliptin compared with α-glucosidase inhibitor (αGI) in 120 of Japanese patients with type 2 diabetes mellitus (T2DM) inadequately controlled on stable ≤2mg/day glimepiride alone [mean hemoglobin A1c (HbA1c) 7.7%] by the randomized, active-controlled, non-inferiority trial. Patients were randomly assigned to receive additional sitagliptin or αGI for 24weeks. The primary endpoint was change in HbA1c from baseline to week 12. After 12weeks, sitagliptin reduced HbA1c by -0.44% (p<0.001) relative to αGI. At 24weeks, the reduction was almost identical between the groups (-0.091%, p=0.47). Gastrointestinal disorders were more common with αGI than with sitagliptin, but only minor hypoglycaemia occurred in both groups at similar frequency. These data suggested that sitagliptin was not inferior to αGI for reduction of HbA1c in Japanese T2DM patients receiving glimepiride alone, and well tolerated with minimum risk of gastrointestinal symptoms and hypoglycaemia.

Original languageEnglish
Pages (from-to)761-765
Number of pages5
JournalDiabetes, Obesity and Metabolism
Volume16
Issue number8
DOIs
Publication statusPublished - 2014 Aug
Externally publishedYes

Keywords

  • DPP-IV inhibitor
  • Randomized trial
  • Sulphonylureas
  • Type 2 diabetes
  • α-glucosidase inhibitor

ASJC Scopus subject areas

  • Internal Medicine
  • Endocrinology, Diabetes and Metabolism
  • Endocrinology

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    Kobayashi, K., Yokoh, H., Sato, Y., Takemoto, M., Uchida, D., Kanatsuka, A., Kuribayashi, N., Terano, T., Hashimoto, N., Sakurai, K., Hanaoka, H., Ishikawa, K., Onishi, S., Yokote, K., An, T., Tokuyama, H., Bujo, H., Kawamura, H., Shibata, T., ... Fujimoto, M. (2014). Efficacy and safety of the dipeptidyl peptidase-4 inhibitor sitagliptin compared with α-glucosidase inhibitor in Japanese patients with type 2 diabetes inadequately controlled on sulfonylurea alone (SUCCESS-2): A multicenter, randomized, open-label, non-inferiority trial. Diabetes, Obesity and Metabolism, 16(8), 761-765. https://doi.org/10.1111/dom.12264