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 Okada & 44 others Yukiko 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, Choon Hee 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

Research output: Contribution to journalArticle

197 Citations (Scopus)

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 1

Fingerprint

Type 2 Diabetes Mellitus
Placebos
Insulin
Hypoglycemia
Glucose
Glucagon-Like Peptide-1 Receptor
ZP10A peptide
Republic of Korea
Philippines
Taiwan
Nausea
Multicenter Studies
Vomiting
Blood Glucose
Fasting
Japan
Safety

All Science Journal Classification (ASJC) codes

  • Internal Medicine
  • Endocrinology, Diabetes and Metabolism
  • Endocrinology

Cite this

Seino, Y. ; Min, K. W. ; Niemoeller, E. ; Takami, A. ; Abe, Nobuyuki ; Arai, Keiko ; Asano, Tsuguyoshi ; Hasegawa, Atsushi ; Hiyoshi, Toru ; Inoue, Toshihiko ; Isomura, Yukinori ; Kaneko, Sizuka ; Kasahara, Tadashu ; Makita, Zenji ; Matoba, Kiyokazu ; Miyaoka, Hiroaki ; Niiya, Tetsuji ; Nishino, Keiichiro ; Noda, Katsumi ; Okada, Akira ; Onishi, Yukiko ; Osonoi, Takeshi ; Ozaki, Mitsuru ; Sekiguchi, Masatomo ; Shiraiwa, Toshihiko ; Sugimoto, Hidekatsu ; Suzuki, Yoshihiko ; Takeuchi, Toru ; Tanaka, Tsuyoshi ; Tateyama, Miki ; Tomonaga, Osamu ; Uchino, Hiroshi ; Watanabe, Nobuaki ; Watanabe, Shuichi ; Watanabe, Takayuki ; Yamauchi, Akira ; Yanagawa, Tatsuo ; Gomez, Maria Honolina ; Panelo, Araceli ; Allyngsy, Rosa ; Ang, Ernesto L. ; Baek, Hong Sun ; Chung, Choon Hee ; Jang, Hak C. ; Kim, Dong Jun ; Kim, In J. ; Kim, Kwang Won ; Kim, Yong S. ; Lee, Hyun Chul ; Lee, Ji Hyun ; Lee, Kwan Woo ; Min, Kyung Wan ; Anh, Chul Woo ; Kim, Doo Man ; Park, Ie B. ; Shong, Minho ; Song, Young D. ; Son, Hyun Shik ; Song, Ki Ho ; Won, Kyu C. ; Yu, Jae M. ; Sheu, Wayne H. ; Pei, Dee ; Chang, Chwen Tzuei. / 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). In: Diabetes, Obesity and Metabolism. 2012 ; Vol. 14, No. 10. pp. 910-917.
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title = "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)",
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.",
author = "Y. Seino and Min, {K. W.} and E. Niemoeller and A. Takami and Nobuyuki Abe and Keiko Arai and Tsuguyoshi Asano and Atsushi Hasegawa and Toru Hiyoshi and Toshihiko Inoue and Yukinori Isomura and Sizuka Kaneko and Tadashu Kasahara and Zenji Makita and Kiyokazu Matoba and Hiroaki Miyaoka and Tetsuji Niiya and Keiichiro Nishino and Katsumi Noda and Akira Okada and Yukiko Onishi and Takeshi Osonoi and Mitsuru Ozaki and Masatomo Sekiguchi and Toshihiko Shiraiwa and Hidekatsu Sugimoto and Yoshihiko Suzuki and Toru Takeuchi and Tsuyoshi Tanaka and Miki Tateyama and Osamu Tomonaga and Hiroshi Uchino and Nobuaki Watanabe and Shuichi Watanabe and Takayuki Watanabe and Akira Yamauchi and Tatsuo Yanagawa and Gomez, {Maria Honolina} and Araceli Panelo and Rosa Allyngsy and Ang, {Ernesto L.} and Baek, {Hong Sun} and Chung, {Choon Hee} and Jang, {Hak C.} and Kim, {Dong Jun} and Kim, {In J.} and Kim, {Kwang Won} and Kim, {Yong S.} and Lee, {Hyun Chul} and Lee, {Ji Hyun} and Lee, {Kwan Woo} and Min, {Kyung Wan} and Anh, {Chul Woo} and Kim, {Doo Man} and Park, {Ie B.} and Minho Shong and Song, {Young D.} and Son, {Hyun Shik} and Song, {Ki Ho} and Won, {Kyu C.} and Yu, {Jae M.} and Sheu, {Wayne H.} and Dee Pei and Chang, {Chwen Tzuei}",
year = "2012",
month = "10",
day = "1",
doi = "10.1111/j.1463-1326.2012.01618.x",
language = "English",
volume = "14",
pages = "910--917",
journal = "Diabetes, Obesity and Metabolism",
issn = "1462-8902",
publisher = "Wiley-Blackwell",
number = "10",

}

Seino, Y, Min, KW, Niemoeller, E, Takami, A, Abe, N, Arai, K, Asano, T, Hasegawa, A, Hiyoshi, T, Inoue, T, Isomura, Y, Kaneko, S, Kasahara, T, Makita, Z, Matoba, K, Miyaoka, H, Niiya, T, Nishino, K, Noda, K, Okada, A, Onishi, Y, Osonoi, T, Ozaki, M, Sekiguchi, M, Shiraiwa, T, Sugimoto, H, Suzuki, Y, Takeuchi, T, Tanaka, T, Tateyama, M, Tomonaga, O, Uchino, H, Watanabe, N, Watanabe, S, Watanabe, T, Yamauchi, A, Yanagawa, T, Gomez, MH, Panelo, A, Allyngsy, R, Ang, EL, Baek, HS, Chung, CH, Jang, HC, Kim, DJ, Kim, IJ, Kim, KW, Kim, YS, Lee, HC, Lee, JH, Lee, KW, Min, KW, Anh, CW, Kim, DM, Park, IB, Shong, M, Song, YD, Son, HS, Song, KH, Won, KC, Yu, JM, Sheu, WH, Pei, D & Chang, CT 2012, '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)', Diabetes, Obesity and Metabolism, vol. 14, no. 10, pp. 910-917. https://doi.org/10.1111/j.1463-1326.2012.01618.x

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

In: Diabetes, Obesity and Metabolism, Vol. 14, No. 10, 01.10.2012, p. 910-917.

Research output: Contribution to journalArticle

TY - JOUR

T1 - 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)

AU - Seino, Y.

AU - Min, K. W.

AU - Niemoeller, E.

AU - Takami, A.

AU - Abe, Nobuyuki

AU - Arai, Keiko

AU - Asano, Tsuguyoshi

AU - Hasegawa, Atsushi

AU - Hiyoshi, Toru

AU - Inoue, Toshihiko

AU - Isomura, Yukinori

AU - Kaneko, Sizuka

AU - Kasahara, Tadashu

AU - Makita, Zenji

AU - Matoba, Kiyokazu

AU - Miyaoka, Hiroaki

AU - Niiya, Tetsuji

AU - Nishino, Keiichiro

AU - Noda, Katsumi

AU - Okada, Akira

AU - Onishi, Yukiko

AU - Osonoi, Takeshi

AU - Ozaki, Mitsuru

AU - Sekiguchi, Masatomo

AU - Shiraiwa, Toshihiko

AU - Sugimoto, Hidekatsu

AU - Suzuki, Yoshihiko

AU - Takeuchi, Toru

AU - Tanaka, Tsuyoshi

AU - Tateyama, Miki

AU - Tomonaga, Osamu

AU - Uchino, Hiroshi

AU - Watanabe, Nobuaki

AU - Watanabe, Shuichi

AU - Watanabe, Takayuki

AU - Yamauchi, Akira

AU - Yanagawa, Tatsuo

AU - Gomez, Maria Honolina

AU - Panelo, Araceli

AU - Allyngsy, Rosa

AU - Ang, Ernesto L.

AU - Baek, Hong Sun

AU - Chung, Choon Hee

AU - Jang, Hak C.

AU - Kim, Dong Jun

AU - Kim, In J.

AU - Kim, Kwang Won

AU - Kim, Yong S.

AU - Lee, Hyun Chul

AU - Lee, Ji Hyun

AU - Lee, Kwan Woo

AU - Min, Kyung Wan

AU - Anh, Chul Woo

AU - Kim, Doo Man

AU - Park, Ie B.

AU - Shong, Minho

AU - Song, Young D.

AU - Son, Hyun Shik

AU - Song, Ki Ho

AU - Won, Kyu C.

AU - Yu, Jae M.

AU - Sheu, Wayne H.

AU - Pei, Dee

AU - Chang, Chwen Tzuei

PY - 2012/10/1

Y1 - 2012/10/1

N2 - 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.

AB - 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.

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U2 - 10.1111/j.1463-1326.2012.01618.x

DO - 10.1111/j.1463-1326.2012.01618.x

M3 - Article

VL - 14

SP - 910

EP - 917

JO - Diabetes, Obesity and Metabolism

JF - Diabetes, Obesity and Metabolism

SN - 1462-8902

IS - 10

ER -