The Multicenter, Open-Label, Observational LEAD-Ph Study: Real-World Safety and Effectiveness of Liraglutide in Filipino Participants with Type 2 Diabetes

Authors

  • Cecilia Jimeno Department of Pharmacology and Toxicology, College of Medicine; Section of Endocrinology, Diabetes and Metabolism, Department of Medicine, Philippine General Hospital, University of the Philippines http://orcid.org/0000-0002-7658-0123
  • Sjoberg Kho Section of Endocrinology, Diabetes and Metabolism, Department of Medicine, University of Santo Tomas Hospital http://orcid.org/0000-0002-8248-9641
  • Grace Ko de los Santos Department of Medicine, Far Eastern University – Nicanor Reyes Medical Foundation, Quezon City http://orcid.org/0000-0001-6642-500X
  • Neslie Buena-Bobis Novo Nordisk Pharmaceuticals (Phils.), Inc. Bonifacio Global City, Taguig http://orcid.org/0000-0002-3737-823X
  • Michael Villa Center for Diabetes, Thyroid and Endocrine Disorders, St. Luke's Medical Center, Global City, Manila http://orcid.org/0000-0003-0181-3719

Keywords:

glucagon-like peptides, liraglutide, type 2 diabetes mellitus, safety, observational study, Philippines

Abstract

Objective. Assess safety and effectiveness of liraglutide among Filipino participants with type 2 diabetes (T2D) in routine clinical practice.

Methodology. A 26-week, prospective, multicenter, open-label, observational study was conducted in adults with T2D prescribed liraglutide (1.2 mg or 1.8 mg) in routine clinical practice in the Philippines. Primary endpoint: incidence rate and type of serious adverse drug reactions (SADRs). Secondary endpoints included other aspects of safety, and effectiveness.

Results. Participants (n=1056) had a mean (standard deviation) age of 53.2 (12.0) years, and glycated hemoglobin (HbA1c) level of 8.8% (2.0). Of 19 ADRs reported in 17 participants, none were SADRs (primary endpoint). No serious adverse events were reported. From baseline to week 26: the proportion of participants with major hypoglycemic episodes (requiring assistance) decreased from 2.0% to 0.2%; and with minor episodes (plasma glucose

Conclusion. During routine clinical use of liraglutide for T2D in the Philippines, no new safety concerns were identified and blood glucose was lowered effectively.

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References

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Published

2018-09-30

How to Cite

Jimeno, C., Kho, S., de los Santos, G. K., Buena-Bobis, N., & Villa, M. (2018). The Multicenter, Open-Label, Observational LEAD-Ph Study: Real-World Safety and Effectiveness of Liraglutide in Filipino Participants with Type 2 Diabetes. Journal of the ASEAN Federation of Endocrine Societies, 33(2), 114. Retrieved from https://asean-endocrinejournal.org/index.php/JAFES/article/view/422

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