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Long-term safety of once-daily lixisenatide in Japanese patients with type 2 diabetes mellitus: GetGoal-Mono-Japan.
J Diabetes Complications. 2015 Nov-Dec; 29(8):1304-9.JD

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+Show Affiliations

Diabetes, Clinical Nutrition and Endocrinology, Kansai Electric Power Hospital, Osaka, Japan. Electronic address: seino.yutaka@e2.kepco.co.jp.Diabetes, Clinical Nutrition and Endocrinology, Kansai Electric Power Hospital, Osaka, Japan.Sanofi, Tokyo, Japan.Sanofi, Frankfurt, Germany.Sanofi, Tokyo, Japan.

Pub Type(s)

Clinical Trial, Phase III
Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

26342556

Citation

Seino, Yutaka, et al. "Long-term Safety of Once-daily Lixisenatide in Japanese Patients With Type 2 Diabetes Mellitus: GetGoal-Mono-Japan." Journal of Diabetes and Its Complications, vol. 29, no. 8, 2015, pp. 1304-9.
Seino Y, Yabe D, Takami A, et al. Long-term safety of once-daily lixisenatide in Japanese patients with type 2 diabetes mellitus: GetGoal-Mono-Japan. J Diabetes Complications. 2015;29(8):1304-9.
Seino, Y., Yabe, D., Takami, A., Niemoeller, E., & Takagi, H. (2015). Long-term safety of once-daily lixisenatide in Japanese patients with type 2 diabetes mellitus: GetGoal-Mono-Japan. Journal of Diabetes and Its Complications, 29(8), 1304-9. https://doi.org/10.1016/j.jdiacomp.2015.07.003
Seino Y, et al. Long-term Safety of Once-daily Lixisenatide in Japanese Patients With Type 2 Diabetes Mellitus: GetGoal-Mono-Japan. J Diabetes Complications. 2015 Nov-Dec;29(8):1304-9. PubMed PMID: 26342556.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Long-term safety of once-daily lixisenatide in Japanese patients with type 2 diabetes mellitus: GetGoal-Mono-Japan. AU - Seino,Yutaka, AU - Yabe,Daisuke, AU - Takami,Akane, AU - Niemoeller,Elisabeth, AU - Takagi,Hiroki, Y1 - 2015/07/06/ PY - 2015/02/17/received PY - 2015/07/01/revised PY - 2015/07/03/accepted PY - 2015/9/7/entrez PY - 2015/9/8/pubmed PY - 2016/9/13/medline KW - FPG KW - GLP-1 KW - HbA(1c) KW - Safety KW - TEAE KW - Type 2 diabetes SP - 1304 EP - 9 JF - Journal of diabetes and its complications JO - J Diabetes Complications VL - 29 IS - 8 N2 - 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. SN - 1873-460X UR - https://www.unboundmedicine.com/medline/citation/26342556/Long_term_safety_of_once_daily_lixisenatide_in_Japanese_patients_with_type_2_diabetes_mellitus:_GetGoal_Mono_Japan_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S1056-8727(15)00271-8 DB - PRIME DP - Unbound Medicine ER -