Five-year efficacy and safety data of exenatide once weekly: long-term results from the DURATION-1 randomized clinical trial

Mayo Clinic Proceedings
Carol H WyshamMichael Trautmann

Abstract

To evaluate the 5-year efficacy and safety of once weekly exenatide. The Diabetes Therapy Utilization: Researching Changes in A1C, Weight and Other Factors Through Intervention with Exenatide Once Weekly (DURATION-1) randomized clinical trial consisted of a 30-week controlled phase (2 mg of exenatide once weekly vs 10 μg of exenatide twice daily) with an open-ended uncontrolled extension (once weekly exenatide only) in patients with type 2 diabetes mellitus on background glucose-lowering therapies (April 15, 2006, through February 21, 2012). At week 30, patients initially receiving 10 μg of exenatide twice daily switched to 2 mg of exenatide once weekly. Study end points included changes from baseline in hemoglobin A1c, fasting plasma glucose, weight, lipids, and blood pressure. Long-term safety data included adverse events, liver and renal function, and heart rate. Of 258 extension-phase patients, 153 (59.3%) completed 5 years of treatment. Hemoglobin A1c levels were significantly and durably reduced from baseline (least-squares mean, -1.6%; 95% CI, -1.8% to -1.4%; vs -1.9% for exenatide once weekly at week 30), and 65 (43.9%) of 148 patients achieved hemoglobin A1c levels of less than 7.0%. Significant improvements in fasting...Continue Reading

References

Nov 25, 2003·Diabetic Medicine : a Journal of the British Diabetic Association·J N HendersonB M Frier
Sep 10, 2005·BMJ : British Medical Journal·G J Taylor, P Wainwright
Dec 6, 2006·The New England Journal of Medicine·Steven E KahnUNKNOWN ADOPT Study Group
Jan 24, 2008·Journal of Evaluation in Clinical Practice·Karla HemmingAnthony G Marson
Apr 23, 2009·Diabetes, Obesity & Metabolism·R GentilellaC M Rotella
Nov 13, 2009·Diabetes Care·Vivian A Fonseca
Mar 11, 2010·Diabetes Care·John B BuseUNKNOWN DURATION-1 Study Group
May 24, 2011·Journal of Diabetes and Its Complications·Dario GiuglianoKatherine Esposito
Jul 21, 2012·Diabetic Medicine : a Journal of the British Diabetic Association·UNKNOWN Diabetes Prevention Program Outcomes Study Research GroupK E Watson
Jan 30, 2013·Diabetes, Metabolic Syndrome and Obesity : Targets and Therapy·Leigh MacconellLisa Porter
Feb 1, 2013·The American Journal of Clinical Nutrition·Olubukola AjalaJonathan Pinkney
Feb 12, 2013·Current Diabetes Reports·Markolf Hanefeld, Peter Bramlage
Apr 20, 2013·Endocrine Practice : Official Journal of the American College of Endocrinology and the American Association of Clinical Endocrinologists·Alan J GarberUNKNOWN American Association of Clinical Endocrinologists
Sep 14, 2013·Diabetology & Metabolic Syndrome·Luciana V VianaJorge L Gross
Apr 16, 2014·The Lancet. Diabetes & Endocrinology·Michaela DiamantMichael E Trautmann

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Citations

May 23, 2015·Expert Review of Cardiovascular Therapy·Marisa B SchauerhamerCarrie McAdam-Marx
Dec 15, 2015·Journal of Controlled Release : Official Journal of the Controlled Release Society·Caslin A GilroyAshutosh Chilkoti
Sep 16, 2015·Postgraduate Medicine·Charles F ShaeferRichard Aguilar
Sep 12, 2015·Mayo Clinic Proceedings·Sakkarin Chirapongsathorn, Pimjai Anthanont
May 6, 2016·Diabetes Therapy : Research, Treatment and Education of Diabetes and Related Disorders·Thomas BlevinsElise Hardy
Jun 25, 2016·Nature Reviews. Endocrinology·Abd A TahraniClifford J Bailey
Oct 22, 2016·Current Diabetes Reports·Susan L Samson, Alan J Garber
Nov 25, 2016·Postgraduate Medicine·A Enrique Caballero
Oct 10, 2015·The Diabetes Educator·Curtis Triplitt, Carolina Solis-Herrera
Jan 14, 2017·Expert Opinion on Pharmacotherapy·Filip K KnopTina Vilsbøll
Mar 17, 2018·Endocrine Practice : Official Journal of the American College of Endocrinology and the American Association of Clinical Endocrinologists·Carol H WyshamPatrick Lefebvre
Aug 30, 2018·Journal of Managed Care & Specialty Pharmacy·Michael HeileMichael Shannon
Aug 30, 2018·Diabetes/metabolism Research and Reviews·Raffaella GentilellaAgostino Consoli
Aug 29, 2018·Diabetes Care·Antonios DourosLaurent Azoulay
Feb 8, 2019·Expert Opinion on Pharmacotherapy·Sebastian M HeimbürgerFilip K Knop
Feb 15, 2019·Advanced Healthcare Materials·Anastasia K Varanko, Ashutosh Chilkoti
Dec 21, 2017·Expert Opinion on Drug Metabolism & Toxicology·María Molina VegaFrancisco J Tinahones
Aug 16, 2016·American Journal of Health-system Pharmacy : AJHP : Official Journal of the American Society of Health-System Pharmacists·Diana IsaacsSneha Baxi Srivastava
Aug 3, 2020·JAAPA : Official Journal of the American Academy of Physician Assistants·Ji Hyun Chun, Amy Butts
May 1, 2016·Expert Review of Endocrinology & Metabolism·Marie Helene Schernthaner-Reiter, Guntram Schernthaner
Aug 7, 2020·JAAPA : Official Journal of the American Academy of Physician Assistants·Ji Hyun Chun, Amy Butts
Feb 13, 2021·European Journal of Drug Metabolism and Pharmacokinetics·Hong CuiMin Xu

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