Randomized, double-blind, placebo-controlled trial of the once-daily GLP-1 receptor agonist lixisenatide in Asian patients with type 2 diabetes insufficiently controlled on basal insulin with or without a sulfonylurea (GetGoal-L-Asia)

Y. Seino, K. W. Min, E. Niemoeller, A. Takami, Nobuyuki Abe, Keiko Arai, Tsuguyoshi Asano, Atsushi Hasegawa, Toru Hiyoshi, Toshihiko Inoue, Yukinori Isomura, Sizuka Kaneko, Tadashu Kasahara, Zenji Makita, Kiyokazu Matoba, Hiroaki Miyaoka, Tetsuji Niiya, Keiichiro Nishino, Katsumi Noda, Akira OkadaYukiko Onishi, Takeshi Osonoi, Mitsuru Ozaki, Masatomo Sekiguchi, Toshihiko Shiraiwa, Hidekatsu Sugimoto, Yoshihiko Suzuki, Toru Takeuchi, Tsuyoshi Tanaka, Miki Tateyama, Osamu Tomonaga, Hiroshi Uchino, Nobuaki Watanabe, Shuichi Watanabe, Takayuki Watanabe, Akira Yamauchi, Tatsuo Yanagawa, Maria Honolina Gomez, Araceli Panelo, Rosa Allyngsy, Ernesto L. Ang, Hong Sun Baek, H. Choon Chung, Hak C. Jang, Dong Jun Kim, In J. Kim, Kwang Won Kim, Yong S. Kim, Hyun Chul Lee, Ji Hyun Lee, Kwan Woo Lee, Kyung Wan Min, Chul Woo Anh, Doo Man Kim, Ie B. Park, Minho Shong, Young D. Song, Hyun Shik Son, Ki Ho Song, Kyu C. Won, Jae M. Yu, Wayne H. Sheu, Dee Pei, Chwen Tzuei Chang

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Abstract

Aims: To assess the efficacy and safety of once-daily lixisenatide versus placebo in Asian patients with type 2 diabetes insufficiently controlled on basal insulin±sulfonylurea. Methods: In this 24-week, randomized, double-blind, placebo-controlled, parallel-group, multicentre study, participants (mean baseline HbA1c 8.53%) from Japan, Republic of Korea, Taiwan and the Philippines received lixisenatide (n=154) or placebo (n=157) in a stepwise dose increase to 20μg once daily. The primary endpoint was HbA1c change from baseline to week 24. Results: Once-daily lixisenatide significantly improved HbA1c versus placebo (LS mean difference vs. placebo=-0.88% [95%CI=-1.116, -0.650]; p<0.0001), and allowed more patients to achieve HbA1c <7.0% (35.6 vs. 5.2%) and ≤6.5% (17.8 vs. 1.3%). Lixisenatide also significantly improved 2-h postprandial plasma glucose and glucose excursion, average 7-point self-monitored blood glucose and fasting plasma glucose. Lixisenatide was well tolerated; 86% of patients on lixisenatide completed the study versus 92% on placebo. Ten (6.5%) lixisenatide and 9 (5.7%) placebo patients experienced serious adverse events. More lixisenatide patients [14 (9.1%)] discontinued for adverse events versus placebo [5 (3.2%)], mainly with gastrointestinal causes. Nausea and vomiting were reported in 39.6 and 18.2% of patients on lixisenatide versus 4.5 and 1.9% on placebo. Symptomatic hypoglycaemia was more frequent with lixisenatide (42.9%) versus placebo (23.6%), but was similar between groups (32.6 vs. 28.3%, respectively), in those not receiving sulfonylureas. No severe hypoglycaemia was reported. Conclusions: In an Asian type 2 diabetes population insufficiently controlled by basal insulin±sulfonylurea, once-daily lixisenatide significantly improved glycaemic control, with a pronounced postprandial effect, and was well tolerated.

Original languageEnglish
Pages (from-to)910-917
Number of pages8
JournalDiabetes, Obesity and Metabolism
Volume14
Issue number10
DOIs
Publication statusPublished - 2012 Oct

All Science Journal Classification (ASJC) codes

  • Internal Medicine
  • Endocrinology, Diabetes and Metabolism
  • Endocrinology

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