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

Abstract

AIMS:

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.

METHODS:

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.

RESULTS:

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.

CONCLUSION:

In Japanese patients with type 2 diabetes mellitus, once-daily lixisenatide monotherapy was well tolerated, with less nausea with the 2-step regimen.

• Authors: Yutaka Seino, Daisuke Yabe, Akane Takami, Elisabeth Niemoeller, Hiroki Takagi
• Journal: Journal of diabetes and its complications (J Diabetes Complications) 2015 Nov-Dec Vol. 29 Issue 8 Pg. 1304-9 ISSN: 1873-460X [Electronic] United States
• PMID: 26342556 (Publication Type: Clinical Trial, Phase III, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2015. Published by Elsevier Inc.

Chemical References

• GLP1R protein, human
• Glucagon-Like Peptide-1 Receptor
• Glycated Hemoglobin A
• Hypoglycemic Agents
• Peptides
• hemoglobin A1c protein, human
• lixisenatide

Topics

• Adult
• Aged
• Diabetes Mellitus, Type 2 (blood, drug therapy, metabolism)
• Drug Administration Schedule
• Female
• Glucagon-Like Peptide-1 Receptor (agonists, metabolism)
• Glycated Hemoglobin (analysis)
• Humans
• Hyperglycemia (prevention & control)
• Hypoglycemia (chemically induced, prevention & control)
• Hypoglycemic Agents (administration & dosage, adverse effects, therapeutic use)
• Incidence
• Injections, Subcutaneous
• Intention to Treat Analysis
• Japan (epidemiology)
• Male
• Middle Aged
• Nausea (chemically induced, epidemiology, physiopathology)
• Patient Dropouts
• Peptides (administration & dosage, adverse effects, therapeutic use)
• Severity of Illness Index
• Weight Loss (drug effects)