Horm Metab Res 2015; 47(12): 895-900
DOI: 10.1055/s-0035-1549875
Endocrine Care
© Georg Thieme Verlag KG Stuttgart · New York

Efficacy and Safety of Lixisenatide in Japanese Patients with Type 2 Diabetes Insufficiently Controlled with Basal Insulin±Sulfonylurea: A Subanalysis of the GetGoal-L-Asia Study

Y. Seino
1   Diabetes, Clinical Nutrition and Endocrinology, Kansai Electric Power Hospital, Osaka, Japan
,
Y. Ikeda
2   Sanofi, Tokyo, Japan
,
E. Niemoeller
3   Sanofi, Frankfurt, Germany
,
D. Watanabe
2   Sanofi, Tokyo, Japan
,
H. Takagi
2   Sanofi, Tokyo, Japan
,
D. Yabe
1   Diabetes, Clinical Nutrition and Endocrinology, Kansai Electric Power Hospital, Osaka, Japan
,
N. Inagaki
4   Department of Diabetes and Clinical Nutrition, Kyoto University Graduate School of Medicine, Kyoto, Japan
› Author Affiliations
Further Information

Publication History

received 17 October 2014

accepted 26 March 2015

Publication Date:
03 June 2015 (online)

Abstract

The aim of the study was to evaluate the efficacy and safety of once-daily lixisenatide 20 μg as add-on to basal insulin with or without sulfonylurea in Asian patients with type 2 diabetes mellitus. The study as a subanalysis of the 159 Japanese patients from the 24-week double-blind GetGoal-L-Asia study (NCT00866658) who received once-daily lixisenatide or placebo. The primary endpoint was change from baseline in HbA1c evaluated using analysis of covariance. Once-daily lixisenatide significantly reduced mean HbA1c [least squares mean difference vs. placebo − 1.1% (− 12 mmol/mol); p<0.0001]. Significantly more patients in the lixisenatide group reached HbA1c targets of < 7% (53 mmol/mol; 31.4 vs. 2.3% for placebo; p<0.0001) and ≤ 6.5% (48 mmol/mol; 12.9 vs. 1.2% for placebo; p=0.0028). Lixisenatide significantly reduced 2-h postprandial plasma glucose (least squares mean difference vs. placebo−8.64 mmol/l; p<0.0001), glucose excursion (least squares mean difference vs. placebo − 7.80 mmol/l; p<0.0001) and fasting plasma glucose (least squares mean difference vs. placebo − 0.96 mmol/l; p=0.0126). Body weight was reduced with lixisenatide but with no significant difference vs. placebo. Gastrointestinal adverse events were more frequent with lixisenatide (61.1 vs. 11.5% for placebo) but were generally transient and mild-to-moderate in intensity. The incidence of symptomatic hypoglycemia was 39.0 vs. 13.5% in patients receiving sulfonylureas and 32.3 vs. 22.9% in those not receiving sulfonylureas, for lixisenatide and placebo, respectively. In Japanese patients with type 2 diabetes mellitus, once-daily lixisenatide was well tolerated and led to significant and clinically relevant improvement in glycemic control, with a pronounced effect on postprandial plasma glucose.

Supporting Information

 
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