The Multicenter, Open-Label, Observational LEAD-Ph Study: Real-World Safety and Effectiveness of Liraglutide in Filipino Participants with Type 2 Diabetes
Keywords:
glucagon-like peptides, liraglutide, type 2 diabetes mellitus, safety, observational study, PhilippinesAbstract
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.
Downloads
References
Kendall DM, Cuddihy RM, Bergenstal RM. Clinical application of incretin-based therapy: Therapeutic potential, patient selection and clinical use. Am J Med. 2009;122(6 Suppl):S37-50. PMID: 19464427. https://doi.org/10.1016/j.amjmed.2009.03.015.
Holst JJ, Knop FK, Vilsbøll T, Krarup T, Madsbad S. Loss of incretin effect is a specific, important, and early characteristic of type 2 diabetes. Diabetes Care. 2011;34 Suppl 2:S251-7. PMID: 21525464. PMCID: PMC3632188. https://doi.org/10.2337/dc11-s227.
Holst JJ, Vilsbøll T, Deacon CF. The incretin system and its role in type 2 diabetes mellitus. Mol Cell Endocrinol. 2009;297(1-2):127-36. PMID: 18786605. https://doi.org/10.1016/j.mce.2008.08.012.
Holst JJ. The physiology of glucagon-like peptide 1. Physiol Rev. 2007;87(4):1409-39. PMID: 17928588. https://doi.org/10.1152/physrev.00034.2006.
Bailey T. Options for combination therapy in type 2 diabetes: Comparison of the ADA/EASD position statement and AACE/ACE algorithm. Am J Med. 2013;126(9 Suppl 1):S10-20. PMID: 23953074. https://doi.org/10.1016/j.amjmed.2013.06.009.
Nauck M. Incretin therapies: Highlighting common features and differences in the modes of action of glucagon-like peptide-1 receptor agonists and dipeptidyl peptidase-4 inhibitors. Diabetes Obes Metab. 2016;18(3):203-16. PMID: 26489970. PMCID: PMC4785614. https://doi.org/10.1111/dom.12591.
Meier JJ. GLP-1 receptor agonists for individualized treatment of type 2 diabetes mellitus. Nat Rev Endocrinol. 2012;8(12):728-42. PMID: 22945360. https://doi.org/10.1038/nrendo.2012.140.
DeFronzo RA, Triplitt CL, Abdul-Ghani M, Cersosimo E. Novel agents for the treatment of type 2 diabetes. Diabetes Spectr. 2014;27(2):100-12. PMID: 26246766 PMCID: PMC4522879. https://doi.org/10.2337/diaspect.27.2.100.
Inzucchi SE, Bergenstal RM, Buse JB, et al. Management of hyperglycemia in type 2 diabetes, 2015: A patient-centered approach: Update to a position statement of the American Diabetes Association and the European Association for the Study of Diabetes. Diabetes Care. 2015;38(1):140-9. https://doi.org/10.2337/dc14-2441.
Garber AJ, Abrahamson MJ, Barzilay JI, et al. AACE comprehensive diabetes management algorithm 2013. Endocr Pract. 2013;19(2):327-36. PMID: 23598536.
Knudsen LB, Nielsen PF, Huusfeldt PO, et al. Potent derivatives of glucagon-like peptide-1 with pharmacokinetic properties suitable for once daily administration. J Med Chem. 2000;43(9):1664-9. PMID: 10794683.
Marre M, Shaw J, Brändle M, et al. Liraglutide, a once-daily human GLP-1 analogue, added to a sulphonylurea over 26 weeks produces greater improvements in glycaemic and weight control compared with adding rosiglitazone or placebo in subjects with Type 2 diabetes (LEAD-1 SU). Diabet Med. 2009;26(3):268-78. PMID: 19317822. PMCID: PMC2871176. https://doi.org/10.1111/j.1464-5491.2009.02666.x.
Nauck M, Frid A, Hermansen K, et al. Efficacy and safety comparison of liraglutide, glimepiride, and placebo, all in combination with metformin, in type 2 diabetes: The LEAD (liraglutide effect and action in diabetes)-2 study. Diabetes Care. 2009;32(1):84-90. PMID: 18931095. PMCID: PMC2606836. https://doi.org/10.2337/dc08-1355.
Garber A, Henry R, Ratner R, et al. Liraglutide versus glimepiride monotherapy for type 2 diabetes (LEAD-3 Mono): A randomised, 52-week, phase III, double-blind, parallel-treatment trial. Lancet. 2009;373(9662):473-81. PMID: 18819705. https://doi.org/10.1016/S0140-6736(08)61246-5.
Russell-Jones D, Vaag A, Schmitz O, et al. Liraglutide vs insulin glargine and placebo in combination with metformin and sulfonylurea therapy in type 2 diabetes mellitus (LEAD-5 met+SU): A randomised controlled trial. Diabetologia. 2009;52(10):2046-55. PMID: 19688338. PMCID: PMC2744824. https://doi.org/10.1007/s00125-009-1472-y.
Buse JB, Rosenstock J, Sesti G, et al. Liraglutide once a day versus exenatide twice a day for type 2 diabetes: A 26-week randomised, parallel-group, multinational, open-label trial (LEAD-6). Lancet. 2009;374(9683):39-47. PMID: 19515413. https://doi.org/10.1016/S0140-6736(09)60659-0.
Zinman B, Gerich J, Buse JB, et al. Efficacy and safety of the human glucagon-like peptide-1 analog liraglutide in combination with metformin and thiazolidinedione in patients with type 2 diabetes (LEAD-4 Met+TZD). Diabetes Care. 2009;32(7):1224-30. PMID: 19289857. PMCID: PMC2699702. https://doi.org/10.2337/dc08-2124.
Nauck M, Frid A, Hermansen K, et al. Long-term efficacy and safety comparison of liraglutide, glimepiride and placebo, all in combination with metformin in type 2 diabetes: 2-year results from the LEAD-2 study. Diabetes Obes Metab. 2013;15(3):204-12. PMID: 22985213. https://doi.org/10.1111/dom.12012.
Pratley R, Nauck M, Bailey T, et al. One year of liraglutide treatment offers sustained and more effective glycaemic control and weight reduction compared with sitagliptin, both in combination with metformin, in patients with type 2 diabetes: A randomised, parallel-group, open-label trial. Int J Clin Pract. 2011;65(4):397-407. PMID: 21355967. PMCID: PMC3085127. https://doi.org/10.1111/j.1742-1241.2011.02656.x.
Garber A, Henry RR, Ratner R, Hale P, Chang CT, Bode B. Liraglutide, a once-daily human glucagon-like peptide 1 analogue, provides sustained improvements in glycaemic control and weight for 2 years as monotherapy compared with glimepiride in patients with type 2 diabetes. Diabetes Obes Metab. 2011;13(4):348-56. PMID: 21205128. PMCID: PMC3084519. https://doi.org/ 10.1111/j.1463-1326.2010.01356.x.
Pratley RE, Nauck M, Bailey T, et al. Liraglutide versus sitagliptin for patients with type 2 diabetes who did not have adequate glycaemic control with metformin: A 26-week, randomised, parallel-group, open-label trial. Lancet. 2010;375(9724):1447-56. PMID: 20417856. https://doi.org/10.1016/S0140-6736(10)60307-8.
Jensen TM, Saha K, Steinberg WM. Is there a link between liraglutide and pancreatitis? A post hoc review of pooled and patient-level data from completed liraglutide type 2 diabetes clinical trials. Diabetes Care. 2015;38(6):1058-66. PMID: 25504028. https://doi.org/10.2337/dc13-1210.
Victoza. Product information. EMA [Internet], 2009 Accessed on February 13, 2016. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/001026/WC500050017.pdf.
Victoza. Prescribing information highlights. FDA [Internet], 2012. Accessed on June 27, 2012. Available from: http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022341s017lbl.pdf.
Yang W, Chen L, Ji Q, et al. Liraglutide provides similar glycaemic control as glimepiride (both in combination with metformin) and reduces body weight and systolic blood pressure in Asian population with type 2 diabetes from China, South Korea and India: A 16-week, randomized, double-blind, active control trial. Diabetes Obes Metab. 2011;13(1):81-8.
PMID: 21114607. https://doi.org.10.1111/j.1463-1326.2010.01323.x.
Zang L, Liu Y, Geng J, et al. Efficacy and safety of liraglutide versus sitagliptin, both in combination with metformin, in Chinese patients with type 2 diabetes: A 26-week, open-label, randomized, active comparator clinical trial. Diabetes Obes Metab. 2016;18(8):803-11. PMID: 27060930. PMCID: PMC5084818. https://doi/.org 10.1111/dom.12674.
Wangnoo SK, Kumar S, Bhattacharyya A, et al. Liraglutide effect and action in diabetes-In (LEAD-In): A prospective observational study assessing safety and effectiveness of liraglutide in patients with type 2 diabetes mellitus treated under routine clinical practice conditions in India. Indian J Endocrinol Metab. 2016;20(6):838-45. https://doi.org/10.4103/2230-8210.189232.
Victoza. Product information. MIMS [Internet], 2011. Accessed on February 13, 2017. Available from: http://www.mims.com/philippines/drug/info/victoza?type=full.
UNITE for Diabetes Philippines. Philippine practice guidelines on the diagnosis and management of diabetes mellitus, 2014. Available from: http://obesity.org.ph/v4/wp-content/uploads/2014/07/Diabetes-United-for-Diabetes-Phil.pdf.
Gautier JF, Martinez L, Penfornis A, et al. Effectiveness and persistence with liraglutide among patients with type 2 diabetes in routine clinical practice--EVIDENCE: A prospective, 2-year follow-up, observational, post-marketing study. Adv Ther. 2015;32(9):838-53. PMID: 26424330. PMCID: PMC4604502. https://doi.org/10.1007/s12325-015-0245-x.
Buysschaert M, D'Hooge D, Preumont V, Roots Study G. ROOTS: A multicenter study in Belgium to evaluate the effectiveness and safety of liraglutide (Victoza®) in type 2 diabetic patients. Diabetes Metab Syndr. 2015;9(3):139-42. PMID: 26004030. https://doi.org/10.1016/j.dsx.2015.05.001.
DeVries JH, Bain SC, Rodbard HW, et al. Sequential intensification of metformin treatment in type 2 diabetes with liraglutide followed by randomized addition of basal insulin prompted by A1C targets. Diabetes Care. 2012;35(7):1446-54. PMID: 22584132. PMCID: PMC3379583. https://doi.org/10.2337/dc11-1928.
Pratley RE, Nauck MA, Bailey T, et al. Efficacy and safety of switching from the DPP-4 inhibitor sitagliptin to the human GLP-1 analog liraglutide after 52 weeks in metformin-treated patients with type 2 diabetes: A randomized, open-label trial. Diabetes Care. 2012;35(10):1986-93. PMID: 22851600. PMCID: PMC3447855. https://doi.org/10.2337/dc11-2113.
Drab SR. Glucagon-like peptide-1 receptor agonists for type 2 diabetes: A clinical update of safety and efficacy. Curr Diabetes Rev. 2016;12(4):403-13. PMID: 26694823. PMCID: PMC5101635.
Ostawal A, Mocevic E, Kragh N, Xu W. Clinical effectiveness of liraglutide in type 2 diabetes treatment in the real-world setting: A systematic literature review. Diabetes Ther. 2016;7(3):411-38. PMID: 27350545. PMCID: PMC5014786. https://doi.org/10.1007/s13300-016-0180-0.
Published
How to Cite
Issue
Section
License
Journal of the ASEAN Federation of Endocrine Societies is licensed under a Creative Commons Attribution-NonCommercial 4.0 International. (full license at this link: http://creativecommons.org/licenses/by-nc/3.0/legalcode).
To obtain permission to translate/reproduce or download articles or use images FOR COMMERCIAL REUSE/BUSINESS PURPOSES from the Journal of the ASEAN Federation of Endocrine Societies, kindly fill in the Permission Request for Use of Copyrighted Material and return as PDF file to jafes@asia.com or jafes.editor@gmail.com.
A written agreement shall be emailed to the requester should permission be granted.
