Safety, tolerability and efficacy of lixisenatide in combination with oral antidiabetic treatment in Japanese patients with type 2 diabetes: An open-label, multicenter study.

ABSTRACT:

Aim/introduction

To assess the overall safety and efficacy of lixisenatide in combination with background oral antidiabetic drug treatment in Japanese patients with type 2 diabetes, as required by Japanese guidelines.

Materials and methods

A phase 3, multicenter, uncontrolled, open-label, four-arm, parallel-group study of Japanese outpatients with type 2 diabetes was carried out; patients received once-daily lixisenatide in combination with biguanide, thiazolidinedione, alpha-glucosidase inhibitors or glinide (NCT01940965). The primary end-point was safety over 52 weeks; secondary end-points included absolute change from baseline in glycated hemoglobin A1c at weeks 24 and 52.

Results

A total of 294 patients were enrolled (biguanide, thiazolidinedione, alpha-glucosidas

SUBMITTER: Seino Y 

PROVIDER: S-EPMC5754542 | biostudies-literature | 2018 Jan

REPOSITORIES: biostudies-literature