1Department of Endocrinology and Metabolism, Kyung Hee University School of Medicine, Seoul, Korea.
2Department of Endocrinology, Gachon University College of Medicine, Incheon, Korea.
3Department of Endocrinology and Metabolism, Hallym University Sacred Heart Hospital, Hallym University College of Medicine, Anyang, Korea.
Copyright © 2015 Korean Diabetes Association
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Study | Design | Proportion Korean patients | GLP-1RA | Mean change in | Discontinuation due to TEAE, n (%) | Proportion of patients with | ||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
HbA1c from baseline, % | Bodyweight from baseline, kg | FPG level from baseline, mmol/L | Morning 2-hr PPG level from baseline, mmol/L | GI adverse events, % | Hypoglycemia, % | |||||||
Nausea | Vomiting | Diarrhea | ||||||||||
Gao et al. (2009) [ | R, DB, PC, PG, MC 12 wk (n=466) | 17% | Exenatide | Exenatide: -1.2 | Exenatide: -1.2 | Exenatide: -1.3 | Postprandial glucose excursions: | Exenatide: 18 (8) | Exenenatide: 25.2 | Exenenatide: 15.8 | Exenenatide: 3.8 | Symptomatic events: |
Placebo: -0.4 | Placebo: -0.1 | Placebo: -0.2 | P<0.001 | Placebo: 1 (0.4) | Placebo: 0.9 | Placebo: Nil | Placebo: 2.6 | Exenatide (35.5%) | ||||
P<0.001 | P<0.001 | P<0.001 | Placebo: (9.1%) | |||||||||
Major events: | ||||||||||||
Exenatide (Nil) | ||||||||||||
Placebo (Nil) | ||||||||||||
Yang et al. (2011) [ | R, DB, PC, PG 16 wk (n=929) | 18% | Liraglutidea | Liraglutide: -1.45 | Liraglutide: -2.4 | Liraglutide: -2.12 | Liraglutide: -3.51 | Liraglutide: 30 (12.8) | No data presented | No data presented | No data presented | Minor events: |
Glimperide: -1.39 | Glimperide: 0.1 | Glimperide: -2.18 | Glimperide: -2.60 | Glimperide: 3 (1.3) | No data presented | |||||||
P=NS | P<0.01 | P=NS | P<0.0001 | Major events: | ||||||||
Exenatide (Nil) | ||||||||||||
Glimperide (2) | ||||||||||||
Seino et al. (2012) [ | R, DB, PC, PG, MC 24 wk (n=311) | 39.5% | Lixisenatide | Lixisenatide: -0.77 | Lixisenatide: -0.38 | Lixisenatide: -0.42 | Lixisenatide: -7.96 | Lixisenatide: 14 (9) | Lixisenatide: 39.6 | Lixisenatide: 18.2 | Lixisenatide: 6.5 | Symptomatic events: |
GETGOAL-L-ASIA | Placebo: 0.11 | Placebo: 0.06 | Placebo: 0.25 | Placebo: -0.14 | Placebo: 5 (3) | Placebo: 4.5 | Placebo: 1.9 | Placebo: 2.5 | Lixisenatide (43%) | |||
P<0.0001 | P=0.08 | P=0.0187 | P<0.0001 | Placebo (24%) | ||||||||
Major events: | ||||||||||||
Lixisenatide (Nil) | ||||||||||||
Placebo (Nil) | ||||||||||||
Shin et al. (2012) [ | Retrospective cohort 24 wk (n=143) | 100% | Exenatide | Exenatide: -1.7 | Exenatide: -3.7 | No data presented | No data presented | No data presented | 16.1 | 11.9 | Nil | Nil |
P<0.001 | P<0.001 | |||||||||||
Pratley et al. (2014) [ | R, DB, PC, PG, MC 32 wk (n=812) | No data presented | Albiglutide | Albiglutide: -0.79 | Albiglutide: -0.64 | Albiglutide: -1.22 | No data presented | Albiglutide: 31 (7.8) | Abliglutide: 9.9 | Abliglutide: 5.0 | Abliglutide: 14.9 | Symptomatic events: |
HARMONY7 | Korea=5/162 study sites | Liraglutide: -0.98 | Liraglutide: -2.19 | Liraglutide: -1.68 | Liraglutide: 41 (10.0) | Liraglutide: 29.2 | Liraglutide: 9.3 | Liraglutide: 13.5 | Albiglutide (10.4%) | |||
P=NS | P<0.001 | P=0.0048 | Liraglutide (13.0%) | |||||||||
Major events: | ||||||||||||
Albiglutide (Nil) | ||||||||||||
Liraglutide (Nil) |
GLP-1RA, glucagon-like peptide-1 receptor agonist; HbA1c, glycosylated hemoglobin; FPG, fasting plasma glucose; PPG, post prandial glucose; TEAE, treatment-emergent adverse event; GI, gastrointestinal; R, randomized; DB, double-blind; PC, placebo-controlled; PG, parallel-group; MC, multicentre; Nil, nothing; NS, not significant. aData presented are for 1.8 mg liraglutide dose.