Abstract
To compare the efficacy and safety of adding the glucagon-like peptide-1 receptor agonist exenatide once weekly (QW) 2 mg or placebo among patients with type 2 diabetes who were inadequately controlled despite titrated insulin glargine (IG) ± metformin. This multicentre, double-blind study (ClinicalTrials.gov identifier: NCT02229383) randomized (1:1) patients with persistent hyperglycaemia after an 8-week titration phase (glycated haemoglobin [HbA1c] 7.0%-10.5% [53-91 mmol/mol]) to exenatide QW or placebo. The primary endpoint was HbA1c change from baseline to week 28. Secondary endpoints included body weight, 2-hour postprandial glucose, and mean daily IG dose. Of 464 randomized patients (mean: age, 58 years; HbA1c, 8.5% [69 mmol/mol]; diabetes duration, 11.3 years), 91% completed 28 weeks. Exenatide QW + IG vs placebo + IG significantly reduced HbA1c (least-squares mean difference, -0.73% [-8.0 mmol/mol]; 95% confidence interval, -0.93%, -0.53% [-10.2, -5.8 mmol/mol]; P < .001; final HbA1c, 7.55% [59 mmol/mol] and 8.24% [67 mmol/mol], respectively); body weight (-1.50 kg; -2.17, -0.84; P < .001); and 2-hour postprandial glucose (-1.52 mmol/L [-27.5 mg/dL]; -2.15, -0.90 [-38.7, -16.2]; P < .001). Significantly more exenatide Q...Continue Reading
References
Dec 24, 2005·Diabetes Care·Laurence KennedyUNKNOWN GOAL AIC Team
Mar 27, 2007·Diabetes Care·Hannele Yki-JärvinenMarkku Vähätalo
Oct 11, 2007·Diabetes, Obesity & Metabolism·L MeneghiniJ-L Selam
Mar 28, 2008·Diabetes Care·Richard M BergenstalMarc Rendell
Dec 2, 2008·Diabetes, Obesity & Metabolism·M R LankischUNKNOWN Orals Plus Apidra and LANTUS (OPAL) study group
Dec 9, 2010·Annals of Internal Medicine·John B BuseJulio Rosenstock
Feb 11, 2011·The Journal of Clinical Endocrinology and Metabolism·Thomas BlevinsLisa Porter
Jun 18, 2011·Diabetes, Obesity & Metabolism·D R OwensM C Riddle
Jul 15, 2011·Diabetes Technology & Therapeutics·Mary Beth DeYoungPaul Herbert
May 31, 2012·Cardiology Research and Practice·Susan GrandyDebbra D Bazata
Nov 17, 2012·Cardiovascular Diabetology·Chun-jun LiDe-min Yu
Apr 9, 2013·Diabetes Care·Matthew C RiddleJulio Rosenstock
May 1, 2013·Diabetes Care·Matthew C RiddleJulio Rosenstock
Apr 20, 2014·Diabetes Care·Steve V EdelmanLeonard C Glass
Jun 6, 2014·Diabetes Care·Julio RosenstockUNKNOWN Harmony 6 Study Group
Jun 21, 2014·Diabetologia·Helena M de WitCees J Tack
Jul 12, 2014·Diabetes Care·Michaela DiamantUNKNOWN 4B Study Group
Aug 13, 2014·Diabetes Care·John B BuseUNKNOWN NN9068-3912 (DUAL-II) Trial Investigators
Sep 16, 2014·Lancet·Conrad EngRavi Retnakaran
Dec 30, 2014·Diabetes Care·Silvio E InzucchiDavid R Matthews
Jan 17, 2015·Diabetic Medicine : a Journal of the British Diabetic Association·C WangI Idris
Jan 9, 2016·Diabetes, Obesity & Metabolism·K KhuntiS K Paul
May 26, 2016·Diabetes Care·Julio RosenstockUNKNOWN GetGoal Duo-2 Trial Investigators
Sep 13, 2016·Diabetes Research and Clinical Practice·Mehul R DalalNella Bieszk
Sep 22, 2016·Diabetes Care·Vanita R ArodaUNKNOWN LixiLan-L Trial Investigators
Sep 22, 2016·The Lancet. Diabetes & Endocrinology·Juan P FríasSerge A Jabbour
Dec 17, 2016·Diabetes Care·UNKNOWN American Diabetes Association
Dec 17, 2016·Diabetes Care·UNKNOWN American Diabetes Association
Jan 7, 2017·Diabetes, Obesity & Metabolism·Michael HorowitzChris K Rayner
Jan 18, 2017·Endocrine Practice : Official Journal of the American College of Endocrinology and the American Association of Clinical Endocrinologists·Alan J GarberGuillermo E Umpierrez
Mar 16, 2017·Diabetes, Obesity & Metabolism·Paolo PozzilliZvonko Milicevic
Mar 23, 2017·Diabetes Care·Maria Ida MaiorinoDario Giugliano
Citations
May 1, 2018·Diabetes, Obesity & Metabolism·Ronald M GoldenbergJean-François Yale
May 24, 2018·Journal of Diabetes·Ann M CarracherKelly L Close
Aug 30, 2018·Journal of Managed Care & Specialty Pharmacy·Yehuda HandelsmanDoron Schneider
Aug 30, 2018·Journal of Managed Care & Specialty Pharmacy·Michael HeileMichael Shannon
Feb 8, 2019·Expert Opinion on Pharmacotherapy·Sebastian M HeimbürgerFilip K Knop
Oct 18, 2018·Current Medical Research and Opinion·Thorsten OttoKirsi Norrbacka
Jul 23, 2020·Diabetes Care·Julio RosenstockPhilip Home
Sep 11, 2020·Journal of Clinical Pharmacy and Therapeutics·Dhiren Patel
Sep 11, 2020·Journal of Clinical Pharmacy and Therapeutics·Jennifer Trujillo
Apr 20, 2020·Diabetes Therapy : Research, Treatment and Education of Diabetes and Related Disorders·Cristian GujaSerge A Jabbour
Apr 18, 2019·Acta Diabetologica·B M BonoraG P Fadini
Sep 11, 2020·Diabetes Care·Jessica A HuthmacherMichael A Nauck
Apr 1, 2020·Journal of the American Heart Association·Mengdie HuLinong Ji
Aug 7, 2020·JAAPA : Official Journal of the American Academy of Physician Assistants·Ji Hyun Chun, Amy Butts
Aug 3, 2020·JAAPA : Official Journal of the American Academy of Physician Assistants·Ji Hyun Chun, Amy Butts
Nov 17, 2020·BMC Medicine·Chu LinLinong Ji
Feb 18, 2021·Journal of Pharmacy Practice·Mandy ChenRoda Plakogiannis
Apr 14, 2020·Journal of the American Association of Nurse Practitioners·Basem M MishrikyJames R Powell
Mar 17, 2021·Diabetes Therapy : Research, Treatment and Education of Diabetes and Related Disorders·Barrie ChubbMichelle Orme
Jun 25, 2021·Expert Opinion on Pharmacotherapy·Mohamad Sirri TaraziAlpana P Shukla