NEW ONCE-WEEKLY GLP-1 RECEPTOR AGONIST - A QUALITATIVE LEAP IN MANAGEMENT OF TYPE 2 DIABETES MELLITUS


Cite item

Full Text

Open Access Open Access
Restricted Access Access granted
Restricted Access Subscription or Fee Access

Abstract

This article presents data on a novel glucagon-like peptide-1 receptor agonist, exenatide once weekly (EQW), which is an extended-release formulation of exenatide. To create an extended-release formulation of exenatide, a Medisorb® microspheres technology was used, which ensure the gradual release of exenatide into the blood plasma. The drug is indicated for treatment of type 2 diabetes mellitus in combination with metformin, sulphonylurea, thiazolidinedione or their combinations in adults who have not achieved adequate glycaemic control on maximally tolerated doses of these oral therapies. In addition to stable safe glycemic control, the drug has a number of non-glycemic effects, including weight loss, blood pressure lowering, protective effect on pancreatic β-cells. The article discusses the main results of the clinical trial program of exenatide QW DURATION, as well as the data of the cardiovascular outcome trial EXSCEL.

Full Text

Restricted Access

About the authors

T. Yu Demidova

Russian National Research Medical University n.a. N.I. Pirogov

Email: t.y.demidova@gmail.com
MD, Prof., Head of the Department of Endocrinology Moscow, Russia

References

  1. International Diabetes Federation. Diabetes Atlas 8th Edition. 2017. (https://www.idf.org/ e-library/epidemiology-research/diabetes-atlas.html).
  2. Дедов И.И., Шестакова М.В., Викулова О.К. Эпидемиология сахарного диабета в Российской Федерации: клинико-статистический анализ по данным Федерального регистра сахарного диабета. Сахарный диабет. 2017;20(1):13-41.
  3. Инструкция по медицинскому применению лекарственного препарата Баета® Лонг (порошок для приготовления суспензии для подкожного введения пролонгированного действия, 2 мг). Регистрационное удостоверение ЛП 004205 от 21.03.2017.
  4. Grimm M., Han J., Weaver C., Griffin P., Schulteis C.T, Dong H., Malloy J. Efficacy, safety, and tolerability of exenatide once weekly in patients with type 2 diabetes mellitus: an integrated analysis of the DURATION trials. Postgrad Med. 2013;125(3):47-57.
  5. Holman R.R., Bethel M.A., Mentz R.J., Thompson V.P., Lokhnygina Y., Buse J.B., Chan J.C., Choi J., Gustavson S.M., Iqbal N., Maggioni A.P., Marso S.P., Öhman P, Pagidipati N.J., Poulter N., Ramachandran A., Zinman B., Hernandez A.F. EXSCEL Study Group. Effects of Once-Weekly Exenatide on Cardiovascular Outcomes in Type 2 Diabetes. N. Engl. J. Med. 2017;377(13):1228-39.
  6. Дедов И.И., Шестакова М.В., Майоров А.Ю. Алгоритмы специализированной медицинской помощи больным сахарным диабетом. 8-й выпуск. Сахарный диабет. 2017;20(1S):1-112.
  7. William T.C. American Diabetes Association Standards of Medical Care in Diabetes - 2017. Diabetes Care. 2017;40(Suppl. 1):S1-S2.
  8. DeYoung M.B., MacConell L., Sarin V., Traut-mann M., Herbert P. Encapsulation of exenatide in poly-(D,L-lactide-co-glycolide) microspheres produced an investigational long-acting once-weekly formulation for type 2 diabetes. Diabetes Technol. Ther. 2011;13(11): 1145-54.
  9. Drucker D.J., Buse J.B., Taylor K., Kendall D.M., Trautmann M., Zhuang D., Porter L. DURATION-1 Study Group. Exenatide once weekly versus twice daily for the treatment of type 2 diabetes: a randomised, open-label, noninferiority study. Lancet. 2008;372:1240-50.
  10. Fineman M.S., Shen L.Z., Taylor K., Kim D.D., Baron A.D. Effectiveness of progressive dose-escalation of exenatide (exendin-4) in reducing dose-limiting side effects in subjects with type 2 diabetes. Diabetes Metab. Res. Rev. 2004;20(5):411-17.
  11. Diamant M., Van Gaal L., Stranks S., Northrup J., Cao D., Taylor K., Trautmann M. Once weekly exenatide compared with insulin glargine titrated to target in patients with type 2 diabetes (DURATION-3): an open-label randomised trial. Lancet. 2010;375(9733):2234-43.
  12. Diamant M., Van Gaal L., Guerci B., Stranks S., Han J., Malloy J., Boardman M.K., Trautmann M.E. Exenatide once weekly versus insulin glargine for type 2 diabetes (DURATION-3): 3-year results of an open-label randomised trial. Lancet Diabetes Endocrinol. 2014;2(6): 464- 73.
  13. Wysham C.H., MacConell L.A., Maggs D.G., Zhou M., Griffin P.S., Trautmann M.E. Five-year efficacy and safety data of exenatide once weekly: long-term results from the DURATION-1 randomized clinical trial. Mayo Clin. Proc. 2015;90:356-65.
  14. Wysham C.H., Philis-Tsimikas A., Klein E.J., Öhman P., Iqbal N., Han J., Henry R.R. DURATION-1 Extension in Patients With Type 2 Diabetes: Efficacy and Tolerability of Exenatide Once Weekly Over 7 Years [abstract]. Diabetes. 2016; 65(suppl 1).
  15. Sarwar N., Gao P., Seshasai S.R., Gobin R., Kaptoge S., Di Angelantonio E., Ingelsson E., Lawlor D.A., Selvin E., Stampfer M., Stehouwer C.D., Lewington S., Pennells L., Thompson A., Sattar N., White I.R., Ray K.K., Danesh J. Diabetes mellitus, fasting blood glucose concentration, and risk of vascular disease: a collaborative metaanalysis of 102 prospective studies. Lancet. 2010;375(9733):2215-22.
  16. European Medicines Agency. Guideline on clinical investigation of medicinal products in the treatment or prevention of diabetes mellitus. http://www.ema.europa.eu/ docs/ en_GB/ document_library/ Scientific_ guideline/ 2012/ 06/WC500129256.pdf
  17. Department of Health and Human Services. Guidance for industry: diabetes mellitus -evaluating cardiovascular risk in new antidiabetic therapies to treat type 2 diabetes. https://www.fda.gov/ downloads/ Drugs/ Guidance ComplianceRegulatoryInformation/ Guidances/ UCM071627.pdf
  18. Holman R.R., Bethel M.A., Mentz R.J., Thompson V.P., Lokhnygina Y., Buse J.B., Chan J.C., Choi J., Gustavson S.M., Iqbal N., Maggioni A.P., Marso S.P., Öhman P., Pagidipati N.J., Poulter N., Ramachandran A., Zinman B., Hernandez A.F. EXSCEL Study Group. Effects of Once-Weekly Exenatide on Cardiovascular Outcomes in Type 2 Diabetes. N. Engl. J. Med. 2017;377(13):1228-39.

Supplementary files

Supplementary Files
Action
1. JATS XML

This website uses cookies

You consent to our cookies if you continue to use our website.

About Cookies