Evaluation of unmet medical need among Japanese patients with type 2 diabetes mellitus and efficacy of Lixisenatide treatment among Asian type 2 diabetes mellitus patients.
OBJECTIVE
This study determined the unmet medical need of basal insulin therapy among type 2 diabetes patients who participated in the ALOHA study. Also a meta-analysis of the GetGoal-Duo1, -L, and -L-Asia trials was conducted to examine the impact of lixisenatide add-on treatment to basal insulin therapy ± OADs specifically among Asian type 2 diabetes patients.


METHODS
The proportions of Japanese patients with an unmet need of diabetes management, defined as not achieving an HbA1c<7% despite having a fasting plasma glucose (FPG)<130 mg/dL, and without an unmet need, defined as having an endpoint HbA1c<7%, regardless of FPG level, were determined for the ALOHA study population, which was conducted as a post-marketing survey for insulin glargine in Japan. For the meta-analysis, all Asian modified intent-to-treat patients with baseline and endpoint HbA1c measurements reported from the 3 GetGoal trials were included.


RESULTS
Among 1013 Japanese type 2 diabetes patients in the ALOHA study, 36% had an unmet need. In the GetGoal-Duo1, -L, and L-Asia trials, 237 Asian patients were treated with lixisenatide add-on treatment to basal insulin and 226 received placebo. Lixisenatide add-on treatment vs. placebo was associated with the following significant mean changes in efficacy outcomes at week 24: HbA1c: -0.6%, p=0.005; FPG: -13.3mg/dL, p=0.004; PPG: -101.4 mg/dL, p<0.001; weight: -0.5 kg, p=0.018; basal insulin dose: -1.6 U, p<0.001.


CONCLUSIONS
Lixisenatide add-on treatment may provide a viable option to address the unmet need of basal insulin therapy among Asian type 2 diabetes patients.
Department of Endocrinology and Metabolism, Graduate School of Medicine, Yokohama City University, Yokohama, Japan. Electronic address: terauchi@yokohama-cu.ac.jp.
Yasuo
Y
Terauchi
Sanofi K.K., Tokyo, Japan.
Yusuke
Y
Naito
Sanofi K.K., Tokyo, Japan.
Yukio
Y
Ikeda
D000368:Aged; D001786:Blood Glucose; D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy*; D005260:Female; D006442:Glycated Hemoglobin / Q000378:metabolism; D006801:Humans; D007004:Hypoglycemic Agents / Q000627:therapeutic use*; D007328:Insulin / Q000627:therapeutic use*; D007564:Japan; D008297:Male; D008875:Middle Aged; D010455:Peptides / Q000627:therapeutic use*; D000067758:Glucagon-Like Peptide-2 Receptor
D001786:Blood Glucose; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D007328:Insulin; D010455:Peptides; C517652:hemoglobin A1c protein, human; C479460:lixisenatide; D000067758:Glucagon-Like Peptide-2 Receptor
GLP-1 agonist; Lixisenatide; Type 2 diabetes mellitus