Long-term safety of once-daily lixisenatide in Japanese patients with type 2 diabetes mellitus: GetGoal-Mono-Japan

Journal of Diabetes and Its Complications
Yutaka SeinoHiroki Takagi

Abstract

This 76-week, open-label, parallel-group study assessed the long-term safety of once-daily lixisenatide monotherapy in Japanese patients with type 2 diabetes mellitus. Patients were randomized to receive lixisenatide in a 2-step or a 1-step dose-increase regimen. The primary objective was to assess the safety of lixisenatide at week 24 by a descriptive comparison of the 2- and 1-step groups. As expected with treatment with a glucagon-like peptide-1 agonist, nausea was the most common treatment-emergent adverse event (2-step group: n=12/33 [36.4%] vs 1-step group: n=18/36 [50.0%] up to week 24). In total, 5/33 patients (15.2%; 2-step group) and 2/36 patients (5.6%; 1-step group) prematurely discontinued treatment up to week 24, mainly due to adverse events. Serious treatment-emergent adverse events occurred in 2/33 patients (6.1%; 2-step group) versus 0/36 patients (0%; 1-step group) up to week 24. Symptomatic hypoglycemia occurred in 2/33 patients (6.1%; 2-step group) versus 1/36 patients (2.8%; 1-step group) up to week 24, with no severe events reported. Glycated hemoglobin, fasting plasma glucose, and body weight were reduced from baseline at weeks 24 and 76. In Japanese patients with type 2 diabetes mellitus, once-daily lixi...Continue Reading

References

Sep 27, 2002·Diabetes/metabolism Research and Reviews·Ryuzo Kawamori
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Jan 1, 2015·Journal of Market Access & Health Policy

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Citations

Jan 31, 2017·The Annals of Pharmacotherapy·Delilah McCartyCassie L Boland
Jun 30, 2018·Pharmacy : Journal of Pharmacy, Education and Practice·Sivanandy PalanisamyYap Nee Chen
Aug 27, 2019·European Journal of Pharmacology·Rubiya KhursheedKamal Dua

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