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, Yasunori 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 Jan 1
Externally publishedYes

Fingerprint

Dipeptidyl-Peptidase IV Inhibitors
Glucosidases
Type 2 Diabetes Mellitus
glimepiride
Safety
Hemoglobins
Hypoglycemia
Sitagliptin Phosphate

Keywords

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

ASJC Scopus subject areas

  • Internal Medicine
  • Endocrinology, Diabetes and Metabolism
  • Endocrinology

Cite this

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

In: Diabetes, Obesity and Metabolism, Vol. 16, No. 8, 01.01.2014, p. 761-765.

Research output: Contribution to journalArticle

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, Tatsuno, I, Ishibashi, T, Nakamura, S, Mikami, K, Yamamoto, K, Yamada, K, Hirota, Y, Tadokoro, N, Tokuyama, T, Ishibashi, R, Nakamura, S, Tashiro, J, Yamamoto, K, Ban, T, Sano, R, Ito, H, Tanaka, T, Nishimura, S, Saito, K, Nishimura, M, Fuse, M, Mimura, M, Suzuki, S, Tachibana, K, Yamada, M, Ishikawa, T, Nakamura, M, Oji, 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, vol. 16, no. 8, pp. 761-765. https://doi.org/10.1111/dom.12264
Kobayashi, K. ; Yokoh, H. ; Sato, Yasunori ; Takemoto, M. ; Uchida, D. ; Kanatsuka, A. ; Kuribayashi, N. ; Terano, T. ; Hashimoto, N. ; Sakurai, K. ; Hanaoka, H. ; Ishikawa, K. ; Onishi, S. ; Yokote, K. ; An, Tokuyoshi ; Tokuyama, Hirotake ; Bujo, Hideaki ; Kawamura, Harukiyo ; Shibata, Takahisa ; Tatsuno, Ichiro ; Ishibashi, Takayuki ; Nakamura, Susumu ; Mikami, Keiji ; Yamamoto, Kazuo ; Yamada, Kenichi ; Hirota, Yusuke ; Tadokoro, Naoko ; Tokuyama, Takahiko ; Ishibashi, Ryoichi ; Nakamura, Shin ; Tashiro, Jun ; Yamamoto, Kyohei ; Ban, Toshiaki ; Sano, Rie ; Ito, Hiroko ; Tanaka, Tomoaki ; Nishimura, Sawako ; Saito, Keiko ; Nishimura, Motonobu ; Fuse, Masami ; Mimura, Masahiro ; Suzuki, Sawako ; Tachibana, Kaori ; Yamada, Masahiko ; Ishikawa, Takahiro ; Nakamura, Miwako ; Oji, Tsuyoshi ; Fujimoto, Masaki. / 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. In: Diabetes, Obesity and Metabolism. 2014 ; Vol. 16, No. 8. pp. 761-765.
@article{9d115c9c48f7462aa7ce192350f37873,
title = "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",
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.",
keywords = "DPP-IV inhibitor, Randomized trial, Sulphonylureas, Type 2 diabetes, α-glucosidase inhibitor",
author = "K. Kobayashi and H. Yokoh and Yasunori Sato and M. Takemoto and D. Uchida and A. Kanatsuka and N. Kuribayashi and T. Terano and N. Hashimoto and K. Sakurai and H. Hanaoka and K. Ishikawa and S. Onishi and K. Yokote and Tokuyoshi An and Hirotake Tokuyama and Hideaki Bujo and Harukiyo Kawamura and Takahisa Shibata and Ichiro Tatsuno and Takayuki Ishibashi and Susumu Nakamura and Keiji Mikami and Kazuo Yamamoto and Kenichi Yamada and Yusuke Hirota and Naoko Tadokoro and Takahiko Tokuyama and Ryoichi Ishibashi and Shin Nakamura and Jun Tashiro and Kyohei Yamamoto and Toshiaki Ban and Rie Sano and Hiroko Ito and Tomoaki Tanaka and Sawako Nishimura and Keiko Saito and Motonobu Nishimura and Masami Fuse and Masahiro Mimura and Sawako Suzuki and Kaori Tachibana and Masahiko Yamada and Takahiro Ishikawa and Miwako Nakamura and Tsuyoshi Oji and Masaki Fujimoto",
year = "2014",
month = "1",
day = "1",
doi = "10.1111/dom.12264",
language = "English",
volume = "16",
pages = "761--765",
journal = "Diabetes, Obesity and Metabolism",
issn = "1462-8902",
publisher = "Wiley-Blackwell",
number = "8",

}

TY - JOUR

T1 - 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)

T2 - A multicenter, randomized, open-label, non-inferiority trial

AU - Kobayashi, K.

AU - Yokoh, H.

AU - Sato, Yasunori

AU - Takemoto, M.

AU - Uchida, D.

AU - Kanatsuka, A.

AU - Kuribayashi, N.

AU - Terano, T.

AU - Hashimoto, N.

AU - Sakurai, K.

AU - Hanaoka, H.

AU - Ishikawa, K.

AU - Onishi, S.

AU - Yokote, K.

AU - An, Tokuyoshi

AU - Tokuyama, Hirotake

AU - Bujo, Hideaki

AU - Kawamura, Harukiyo

AU - Shibata, Takahisa

AU - Tatsuno, Ichiro

AU - Ishibashi, Takayuki

AU - Nakamura, Susumu

AU - Mikami, Keiji

AU - Yamamoto, Kazuo

AU - Yamada, Kenichi

AU - Hirota, Yusuke

AU - Tadokoro, Naoko

AU - Tokuyama, Takahiko

AU - Ishibashi, Ryoichi

AU - Nakamura, Shin

AU - Tashiro, Jun

AU - Yamamoto, Kyohei

AU - Ban, Toshiaki

AU - Sano, Rie

AU - Ito, Hiroko

AU - Tanaka, Tomoaki

AU - Nishimura, Sawako

AU - Saito, Keiko

AU - Nishimura, Motonobu

AU - Fuse, Masami

AU - Mimura, Masahiro

AU - Suzuki, Sawako

AU - Tachibana, Kaori

AU - Yamada, Masahiko

AU - Ishikawa, Takahiro

AU - Nakamura, Miwako

AU - Oji, Tsuyoshi

AU - Fujimoto, Masaki

PY - 2014/1/1

Y1 - 2014/1/1

N2 - 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.

AB - 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.

KW - DPP-IV inhibitor

KW - Randomized trial

KW - Sulphonylureas

KW - Type 2 diabetes

KW - α-glucosidase inhibitor

UR - http://www.scopus.com/inward/record.url?scp=84904395436&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84904395436&partnerID=8YFLogxK

U2 - 10.1111/dom.12264

DO - 10.1111/dom.12264

M3 - Article

C2 - 24447683

AN - SCOPUS:84904395436

VL - 16

SP - 761

EP - 765

JO - Diabetes, Obesity and Metabolism

JF - Diabetes, Obesity and Metabolism

SN - 1462-8902

IS - 8

ER -