Dataset Information

Safety, tolerability and efficacy of lixisenatide as monotherapy in Japanese patients with type 2 diabetes mellitus: An open-label, multicenter study.

ABSTRACT:

Aim/introduction

To assess the overall safety of lixisenatide monotherapy in Japanese patients with type 2 diabetes mellitus.

Materials and methods

Patients with type 2 diabetes mellitus, previously treated with ?1 oral antidiabetic drug, were enrolled in an uncontrolled, open-label, single-arm study over 24 and 52 weeks. Any oral antidiabetic drug treatment was stopped at the start of the 6-week run-in period. From baseline, patients received once-daily lixisenatide monotherapy (10 ?g for 1 week, 15 ?g for 1 week, 20 ?g thereafter) for 52 weeks (first 140 patients enrolled) or 24 weeks (subsequently enrolled patients). The primary end-point was safety over 24 and 52 weeks. Secondary efficacy end-points included absolute change in glycated hemoglobin, fasting plasma glucose and bodyweight from baseline.

Results

Of 428 patients screened, 361 and 140 were treated for 24 and 52 weeks, respectively; 88.4 and 90.0% completed treatment. During the 24- and 52-week treatment periods, 268/361 (74.2%) and 117/140 (83.6%) patients, respectively, had treatment-emergent adverse events; the most frequently reported was nausea (33.2 and 31.4%, respectively). The risk of severe hypoglycemia was low; only one case was reported. Lixisenatide treatment resulted in a decrease in mean glycated hemoglobin A1c (-0.98 and -0.86%), fasting plasma glucose (-1.05 and -0.85 mmol/L), and bodyweight (-1.33 and -1.48 kg) for the 24- and 52-week treatment periods, respectively.

Conclusions

Once-daily lixisenatide monotherapy was associated with a safety profile in line with the glucagon-like peptide-1 receptor agonist class, and improved glycemic control in Japanese patients with type 2 diabetes mellitus.

SUBMITTER: Seino Y

PROVIDER: S-EPMC5754539 | biostudies-literature | 2018 Jan

REPOSITORIES: biostudies-literature

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Publications

Safety, tolerability and efficacy of lixisenatide as monotherapy in Japanese patients with type 2 diabetes mellitus: An open-label, multicenter study.

Seino Yutaka Y Terauchi Yasuo Y Wang Xiangling X Watanabe Daisuke D Niemoeller Elisabeth E

Journal of diabetes investigation 20170612 1

<h4>Aim/introduction</h4>To assess the overall safety of lixisenatide monotherapy in Japanese patients with type 2 diabetes mellitus.<h4>Materials and methods</h4>Patients with type 2 diabetes mellitus, previously treated with ≤1 oral antidiabetic drug, were enrolled in an uncontrolled, open-label, single-arm study over 24 and 52 weeks. Any oral antidiabetic drug treatment was stopped at the start of the 6-week run-in period. From baseline, patients received once-daily lixisenatide monotherapy ( ...[more]

PMID: 28195447

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Dataset Information

Safety, tolerability and efficacy of lixisenatide as monotherapy in Japanese patients with type 2 diabetes mellitus: An open-label, multicenter study.

Aim/introduction

Materials and methods

Results

Conclusions

Publications

Safety, tolerability and efficacy of lixisenatide as monotherapy in Japanese patients with type 2 diabetes mellitus: An open-label, multicenter study.

Similar Datasets

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