The efficacy and safety of exenatide once weekly in patients with type 2 diabetes

References

• Marathe CS, Rayner CK, Kl J, et al. Effects of GLP-1 and incretin-based therapies on gastrointestinal motor function. Exp Diabetes Res. 2011;2011:279530.
   PubMedGoogle Scholar
• Marso SP, Daniels GH, Brown-Frandsen K, et al. Liraglutide and cardiovascular outcomes in type 2 diabetes. N Engl J Med. 2016;375:311–322.
   PubMed Web of Science ®Google Scholar
• Eng J, Kleinman WA, Singh L, et al. Isolation and characterization of exendin-4, an exendin-3 analogue, from Heloderma suspectum venom. Further evidence for an exendin receptor on dispersed acini from guinea pig pancreas. J Biol Chem. 1992;267:7402–7405.
   PubMed Web of Science ®Google Scholar
• Hansen PA, Corbett JA. Incretin hormones and insulin sensitivity. Trends Endocrinol Metab. 2005;16:135–136.
   PubMed Web of Science ®Google Scholar
• Kieffer TJ, McIntosh CH, Pederson RA. Degradation of glucose-dependent insulinotropic polypeptide and truncated glucagon-like peptide 1 in vitro and in vivo by dipeptidyl peptidase IV. Endocrinology. 1995;136:3585–3596.
   PubMed Web of Science ®Google Scholar
• Deacon CF, Nauck MA, Toft-Nielsen M, et al. Both subcutaneously and intravenously administered glucagon-like peptide I are rapidly degraded from the NH2-terminus in type II diabetic patients and in healthy subjects. Diabetes. 1995;44:1126–1131.
   PubMed Web of Science ®Google Scholar
• Parkes DG, Pittner R, Jodka C, et al. Insulinotropic actions of exendin-4 and glucagon-like peptide-1 in vivo and in vitro. Metabolism. 2001;50:583–589.
   PubMed Web of Science ®Google Scholar
• Egan JM, Clocquet AR, Elahi D. The insulinotropic effect of acute exendin-4 administered to humans: comparison of nondiabetic state to type 2 diabetes. J Clin Endocrinol Metab. 2002;87:1282–1290.
   PubMed Web of Science ®Google Scholar
• Young AA, Gedulin BR, Bhavsar S, et al. Glucose-lowering and insulin-sensitizing actions of exendin-4: studies in obese diabetic (ob/ob, db/db) mice, diabetic fatty Zucker rats, and diabetic rhesus monkeys (Macaca mulatta). Diabetes. 1999;48:1026–1034.
   PubMed Web of Science ®Google Scholar
• Kolterman OG, Buse JB, Fineman MS, et al. Synthetic exendin-4 (exenatide) significantly reduces postprandial and fasting plasma glucose in subjects with type 2 diabetes. J Clin Endocrinol Metab. 2003;88:3082–3089.
   PubMed Web of Science ®Google Scholar
• Linnebjerg H, Park S, Kothare PA, et al. Effect of exenatide on gastric emptying and relationship to postprandial glycemia in type 2 diabetes. Regul Pept. 2008;151:123–129.
   PubMedGoogle Scholar
• Holman RR, Bethel MA, Mentz RJ, et al. Effects of once-weekly exenatide on cardiovascular outcomes in type 2 diabetes. N Engl J Med. 2017;377:1228–1239.
   Web of Science ®Google Scholar
• DeYoung MB, MacConell L, Sarin V, et al. 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;13:1145–1154.
   PubMed Web of Science ®Google Scholar
• Fineman M, Flanagan S, Taylor K, et al. Pharmacokinetics and pharmacodynamics of exenatide extended-release after single and multiple dosing. Clin Pharmacokinet. 2011;50:65–74.
   PubMed Web of Science ®Google Scholar
• European Medicines Association. Bydureon solution for injection. Summary of product characteristics 2017 [Internet]. 2017.
   Google Scholar
• Kim D, MacConell L, Zhuang D, et al. Effects of once-weekly dosing of a long-acting release formulation of exenatide on glucose control and body weight in subjects with type 2 diabetes. Diabetes Care. 2007;30:1487–1493.
   PubMed Web of Science ®Google Scholar
• Iwamoto K, Nasu R, Yamamura A, et al. Safety, tolerability, pharmacokinetics, and pharmacodynamics of exenatide once weekly in Japanese patients with type 2 diabetes. Endocr J. 2009;56:951–962.
   PubMed Web of Science ®Google Scholar
• Cui YM, Guo XH, Zhang DM, et al. Pharmacokinetics, safety, and tolerability of single- and multiple-dose exenatide once weekly in Chinese patients with type 2 diabetes mellitus. J Diabetes. 2013;5:127–135.
   PubMed Web of Science ®Google Scholar
• Stauder U, Elton H, Penfornis A, et al. Comparative assessment of lixisenatide, exenatide, and liraglutide pen devices: a pilot user-based study. J Diabetes Sci Technol. 2014;8:123–131.
   PubMedGoogle Scholar
• LaRue S, Malloy J. Evaluation of the dual-chamber pen design for the injection of exenatide once weekly for the treatment of type 2 diabetes. J Diabetes Sci Technol. 2015;9:815–821.
   PubMedGoogle Scholar
• Buse JB, Drucker DJ, Taylor KL, et al. DURATION-1: exenatide once weekly produces sustained glycemic control and weight loss over 52 weeks. Diabetes Care. 2010;33:1255–1261.
   PubMed Web of Science ®Google Scholar
• Blevins T, Pullman J, Malloy J, et al. DURATION-5: exenatide once weekly resulted in greater improvements in glycemic control compared with exenatide twice daily in patients with type 2 diabetes. J Clin Endocrinol Metab. 2011;96:1301–1310.
   Google Scholar
• Wysham C, Bergenstal R, Malloy J, et al. DURATION-2: efficacy and safety of switching from maximum daily sitagliptin or pioglitazone to once-weekly exenatide. Diabet Med. 2011;28:1206–1212.
   PubMed Web of Science ®Google Scholar
• Russell-Jones D, Cuddihy RM, Hanefeld M, et al. Efficacy and safety of exenatide once weekly versus metformin, pioglitazone, and sitagliptin used as monotherapy in drug-naive patients with type 2 diabetes (DURATION-4): A 26-week double-blind study. Diabetes Care. 2012;35:252–258.
   PubMed Web of Science ®Google Scholar
• Diamant M, Van Gaal L, Stranks S, et al. 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;375:2234–2243.
   PubMed Web of Science ®Google Scholar
• Buse JB, Nauck M, Forst T, et al. Exenatide once weekly versus liraglutide once daily in patients with type 2 diabetes (DURATION-6): a randomised, open-label study. Lancet. 2013;381:117–124.
   PubMed Web of Science ®Google Scholar
• Öhman P, Wysham CH, Philis-Tsimikas A, et al. DURATION-1 extension in patients with type 2 diabetes: efficacy and tolerability of exenatide once weekly over 7 years. Present Am Diabetes Assoc 76th Sci Sess. 2016;10–14.
   Google Scholar
• Frías JP, Guja C, Hardy E, et al. Exenatide once weekly plus dapagliflozin once daily versus exenatide or dapagliflozin alone in patients with type 2 diabetes inadequately controlled with metformin monotherapy (DURATION-8): a 28 week, multicentre, double-blind, phase 3, randomised control. Lancet Diabetes Endocrinol. 2016;4:1004–1016.
   PubMed Web of Science ®Google Scholar
• Guja C, Frías JP, Somogyi A, et al. Effect of exenatide QW or placebo, both added to titrated insulin glargine, in uncontrolled type 2 diabetes: the DURATION-7 randomized study. Diabetes Obes Metab. 2018;20:1602–1614.
   Web of Science ®Google Scholar
• Bergenstal RM, Wysham C, MacConell L, et al. Efficacy and safety of exenatide once weekly versus sitagliptin or pioglitazone as an adjunct to metformin for treatment of type 2 diabetes (DURATION-2): a randomised trial. Lancet. 2010;376:431–439.
   PubMed Web of Science ®Google Scholar
• Drucker DJ, Buse JB, Taylor K, et al. Exenatide once weekly versus twice daily for the treatment of type 2 diabetes: a randomised, open-label, non-inferiority study. Lancet. 2008;372:1240–1250.
   PubMed Web of Science ®Google Scholar
• Ahmann AJ, Capehorn M, Charpentier G, et al. Efficacy and safety of once-weekly semaglutide versus exenatide ER in subjects with type 2 diabetes (SUSTAIN 3): A 56-week, open-label, randomized clinical trial. Diabetes Care. 2018;41:258–266.
   PubMed Web of Science ®Google Scholar
• Mody R, Huang Q, Yu M, et al. Comparative glycemic effectiveness of dulaglutide vs. liraglutide and exenatide QW in a U.S. Real-world setting. Diabetes. 2018;67:1071– P.
   Google Scholar
• Diamant M, Van GL, Guerci B, et al. 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;2:464–473. www.thelancet.com/diabetes-endocrinology
   Web of Science ®Google Scholar
• Wysham CH, MacConell LA, Maggs DG, et al. Five-year efficacy and safety data of exenatide once weekly: long-term results from the DURATION-1 randomized clinical trial. Mayo Clin Proc. 2015;90:356–365.
   PubMed Web of Science ®Google Scholar
• Henry RR, Klein EJ, Han J, et al. Efficacy and tolerability of exenatide once weekly over 6 years in patients with type 2 diabetes: an uncontrolled open-label extension of the DURATION-1 study. Diabetes Technol Ther. 2016;18:677–686.
   Google Scholar
• Pencek R, Blickensderfer A, Li Y, et al. Exenatide once weekly for the treatment of type 2 diabetes: effectiveness and tolerability in patient subpopulations. Int J Clin Pract. 2012;66:1021–1032.
   PubMed Web of Science ®Google Scholar
• Knop FK, Brønden A, Vilsbøll T. Exenatide: pharmacokinetics, clinical use, and future directions. Expert Opin Pharmacother. 2017;18:555–571.
   PubMed Web of Science ®Google Scholar
• Genovese S, Mannucci E, Ceriello A. A review of the long-term efficacy, tolerability, and safety of exenatide once weekly for type 2 diabetes. Adv Ther. 2017;34:1791–1814.
   PubMed Web of Science ®Google Scholar
• Gurney K, MacConell L, Malloy J, et al. Safety and tolerability of exenatide once weekly in patients with type 2 diabetes: an integrated analysis of 4,328 patients. Diabetes, Metab Syndr Obes Targets Ther. 2015;8:241.
   PubMed Web of Science ®Google Scholar
• AstraZeneca Pharmaceuticals LP Bydureon (exenatide extended-release for injectable suspension): US prescribing information. 2015.
   Google Scholar
• Fineman MS, Mace KF, Diamant M, et al. Clinical relevance of anti-exenatide antibodies: safety, efficacy and cross-reactivity with long-term treatment. Diabetes Obes Metab. 2012;14:546–554.
   PubMed Web of Science ®Google Scholar
• Buse JB, Garber A, Rosenstock J, et al. Liraglutide treatment is associated with a low frequency and magnitude of antibody formation with no apparent impact on glycemic response or increased frequency of adverse events: results from the Liraglutide Effect and Action in Diabetes (LEAD) trials. J Clin Endocrinol Metab. 2011;96:1695–1702.
   PubMed Web of Science ®Google Scholar
• Davies M, Heller S, Sreenan S, et al. Once-weekly exenatide versus once- or twice-daily insulin detemir: randomized, open-label, clinical trial of efficacy and safety in patients with type 2 diabetes treated with metformin alone or in combination with sulfonylureas. Diabetes Care. 2013;36:1368–1376.
   PubMed Web of Science ®Google Scholar
• Diamant M, Van Gaal L, Stranks S, et al. Safety and efficacy of once-weekly exenatide compared with insulin glargine titrated to target in patients with type 2 diabetes over 84 weeks. Diabetes Care. 2012;35:683–689.
   PubMed Web of Science ®Google Scholar
• Marso SP, Hardy E, Han J, et al. Changes in heart rate associated with exenatide once weekly: pooled analysis of clinical data in patients with type 2 diabetes. Diabetes Ther. 2018;9:551–564.
   PubMed Web of Science ®Google Scholar
• Elashoff M, A V M, Gier B, et al. Pancreatitis, pancreatic, and thyroid cancer with glucagon-like peptide-1-based therapies. Gastroenterology. 2011;141:150–156.
   PubMed Web of Science ®Google Scholar
• Egan AG, Blind E, Dunder K, et al. Pancreatic safety of incretin-based drugs–FDA and EMA assessment. N Engl J Med. 2014;370:794–797.
   PubMed Web of Science ®Google Scholar
• Knudsen LB, Madsen LW, Andersen S, et al. Glucagon-like peptide-1 receptor agonists activate rodent thyroid C-cells causing calcitonin release and C-cell proliferation. Endocrinology. 2010;151:1473–1486.
   PubMed Web of Science ®Google Scholar
• Nauck MA, Friedrich N. Do GLP-1-based therapies increase cancer risk? Diabetes Care. 2013;36:S245–S252.
   PubMed Web of Science ®Google Scholar
• Davies MJ, D’Alessio DA, Fradkin J, et al. Management of hyperglycemia in type 2 diabetes, 2018. A consensus report by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). Diabetes Care. 2018;41:2669–2701.
   Web of Science ®Google Scholar
• American Diabetes A. Standards of medical care in diabetes-2018. Diabetes Care. 2018 Jan 1;41:S1–S159.
   PubMedGoogle Scholar
• Marso SP, Bain SC, Consoli A, et al. Semaglutide and cardiovascular outcomes in patients with type 2 diabetes. N Engl J Med. 2016;375:1834–1844.
   PubMed Web of Science ®Google Scholar
• Wysham CH, Rosenstock J, Vetter ML, et al. Efficacy and tolerability of the new autoinjected suspension of exenatide once weekly versus exenatide twice daily in patients with type 2 diabetes. Diabetes Obes Metab. 2018;20:165–172.
   PubMed Web of Science ®Google Scholar
• Gadde KM, Vetter ML, Iqbal N, et al. Efficacy and safety of autoinjected exenatide once-weekly suspension versus sitagliptin or placebo with metformin in patients with type 2 diabetes: the DURATION-NEO-2 randomized clinical study. Diabetes Obes Metab. 2017;19:979–988.
   PubMed Web of Science ®Google Scholar
• Heller SR, Pratley RE, Sinclair A, et al. Glycaemic outcomes of an Individualized treatMent aPproach for oldER vulnerable patIents: A randomized, controlled stUdy in type 2 diabetes Mellitus (IMPERIUM). Diabetes, Obes. Metab. 2018;20:148–156.
   Google Scholar
• Henry RR, Rosenstock J, Logan DK, et al. Randomized trial of continuous subcutaneous delivery of exenatide by ITCA 650 versus twice-daily exenatide injections in metformin-treated type 2 diabetes. Diabetes Care. 2013;36:2559–2565.
   Google Scholar
• Henry RR, Logan D, Alessi T, et al. A randomized, open-label, multicenter, 4-week study to evaluate the tolerability and pharmacokinetics of ITCA 650 in patients with type 2 diabetes. Clin Ther. 2013;35:634–645.e1.
   Google Scholar
• Intarcia Therapeutics. A study to evaluate ITCA 650 compared to sitagliptin as add-on therapy for the treatment of type 2 diabetes. ClinicalTrials.gov [Internet]. NLM Identifier NCT01455870. 2000. [cited 2018 Jun 01]. Available from: https://clinicaltrials.gov/ct2/show/NCT01455870
   Google Scholar
• Henry RR, Rosenstock J, Denham DS, Prabhakar P, Kjems L, Baron MA. Clinical Impact of ITCA 650, a Novel Drug-Device GLP-1 Receptor Agonist, in Uncontrolled Type 2 Diabetes and Very High Baseline HbA(1c): The FREEDOM-1 HBL (High Baseline) Study. Diabetes Care. 2018 Mar;41(3):613-619. doi: 10.2337/dc17-1519. Epub 2018 Jan 4.
   Google Scholar
• Wysham CH, MacConell L, Hardy E. Efficacy and safety of multiple doses of exenatide once-monthly suspension in patients with type 2 diabetes: A phase II randomized clinical trial. Diabetes Care. 2016;39:1768–1776.
   PubMed Web of Science ®Google Scholar
• Rosenstock J, Bruse JB, Azeem R, et al. Efficacy and safety of ITCA 650, a novel drug-device GLP-1 receptor agonist, in type 2 diabetes uncontrolled with oral antidiabetes drugs: the FREEDOM-1 trial. Diabetes Care. 2018;41:613–619.
   PubMed Web of Science ®Google Scholar
• Intarcia Therapeutics. A study to evaluate cardiovascular outcomes in patients with type 2 diabetes treated with ITCA 650. ClinicalTrials.gov [Internet]. NLM Identifier NCT01455896. 2000 [cited 2018 Jun 01]. Available from: https://clinicaltrials.gov/ct2/show/NCT01455896
   Google Scholar
• Intarcia Therapeutics. A study to evaluate cardiovascular outcomes in patients with type 2 diabetes treated with ITCA 650. ClinicalTrials.gov [Internet]. NLM Identifier NCT01455909. 2000. [cited 2018 Jun 01]. Available from: https://clinicaltrials.gov/ct2/show/NCT01455909
   Google Scholar
• Intarcia Therapeutics. Study to evaluate ITCA 650 compared to glimepiride as add on therapy for the treatment of type 2 diabetes. ClinicalTrials.gov [Internet]. NLM Identifier NCT01455922. 2000. [cited 2018 Jun 01]. Available from: https://clinicaltrials.gov/ct2/show/NCT01455922
   Google Scholar
• Intarcia Therapeutics. Comparison of efficacy, safety, and tolerability of ITCA 650 to empagliflozin and glimepiride as add-on metformin. ClinicalTrials.gov [Internet]. NLM Identifier NCT03060980. 2000. [cited 2018 Jun 01]. Available from: https://clinicaltrials.gov/ct2/show/NCT03060980
   Google Scholar
• Intarcia Therapeutics. Study of the safety and tolerability of switching to ITCA 650 in patients with type 2 diabetes receiving liraglutide. ClinicalTrials.gov [Internet]. NLM Identifier NCT02638805. 2000. [cited 2018 Jun 01]. Available from: https://clinicaltrials.gov/ct2/show/NCT02638805
   Google Scholar
• Universitätsklinikum Hamburg-Eppendorf; AstraZeneca. The potential of dapagliflozin plus exenatide in obese insulin-resistant patients. ClinicalTrials.gov [Internet].  NLM Identifier NCT03419624. 2000. [cited 2018 Jun 01]. Available from: https://clinicaltrials.gov/ct2/show/NCT03419624
   Google Scholar
• AstraZeneca. Safety and efficacy study of exenatide once weekly in adolescents with type 2 diabetes. ClinicalTrials.gov [Internet]. NLM Identifier NCT01554618. 2000. [cited 2018 Jun 01]. Available from: https://clinicaltrials.gov/ct2/show/NCT01554618
   Google Scholar
• Yale University. A phase II trial to examine the effect of subcutaneous exenatide (Bydureon®) on glucose control in patients with type I diabetes. ClinicalTrials.gov [Internet]. NLM Identifier NCT01928329. 2000. [cited 2018 Jun 01]. Available from: https://clinicaltrials.gov/ct2/show/NCT01928329
   Google Scholar
• Ingrid Jazet; AstraZeneca. Exenatide and brown adipose tissue (exe01). ClinicalTrials.gov [Internet]. NLM Identifier NCT03002675. 2000. [cited 2018 Jun 01]. Available from: https://clinicaltrials.gov/ct2/show/NCT03002675
   Google Scholar
• The University of Texas Health Science Center at San Antonio; AstraZeneca. Effect of GLP-1 receptor agonist, exenatide on glucosuria induced elevation in ENDOGENOUS GLUCOSE PRODUCTION (EGP). ClinicalTrials.gov [Internet]. NLM Identifier NCT02981069. 2000. [cited 2018 Jun 01]. Available from: https://clinicaltrials.gov/ct2/show//NCT02981069
   Google Scholar
• Medical University of Vienna; AstraZeneca. Effects of combined dapagliflozin and exenatide versus dapagliflozin and placebo on ectopic lipids in patients with uncontrolled type 2 diabetes Mellitus. (EXENDA). ClinicalTrials.gov [Internet]. NLM Identifier NCT03007329. 2000. [cited 2018 Jun 01]. Available from: https://clinicaltrials.gov/ct2/show/NCT03007329
   Google Scholar
• Woman’s Hospital Louisiana; Astrazeneca. DAPA, EQW, DAPA/MET ER and PHEN/TPM ER in obese women with polycysticovary syndrome (PCOS). ClinicalTrials.gov [Internet]. NLM Identifier NCT02635386. 2000. [cited 2018 Jun 01]. Available from: https://clinicaltrials.gov/ct2/show/NCT02635386
   Google Scholar
• University of Minnesota. Enhancing weight loss maintenance with GLP-1RA (BYDUREONTM) in adolescents with severe obesity. In: ClinicalTrials.gov [Internet]. NLM Identifier NCT02496611. 2000. [cited 2018 Jun 01]. Available from: https://clinicaltrials.gov/ct2/show/NCT02496611
   Google Scholar
• Phoenix VA Health Care System. Effect of Bydureon on Carotid Atherosclerosis Progression in Type 2 Diabetes Mellitus. In: ClinicalTrials.gov [Internet]. NLM Identifier NCT02162550. 2000. [cited 2018 Jun 01]. Available from: https://clinicaltrials.gov/ct2/show/NCT02162550
   Google Scholar
• Hernandez AF, Green JB, Janmohamed S, et al. Albiglutide and cardiovascular outcomes in patients with type 2 diabetes and cardiovascular disease (Harmony Outcomes): a double-blind, randomised placebo-controlled trial. Lancet. 2018;392:1519–1529.
   PubMedGoogle Scholar
• Brønden A, Fk K, Mb C. Clinical pharmacokinetics and pharmacodynamics of albiglutide. Clin Pharmacokinet. 2017;56:719–731.
   PubMed Web of Science ®Google Scholar
• Unni S, Wittbrodt E, Ma J, et al. Comparative effectiveness of once-weekly glucagon-like peptide-1 receptor agonists with regard to 6-month glycaemic control and weight outcomes in patients with type 2 diabetes. Diabetes Obes Metab. 2018;20:468–473.
   PubMed Web of Science ®Google Scholar
• Gerstein HC, Colhoun HM, Dagenais GR, et al. Design and baseline characteristics of participants in the researching cardiovascular events with a weekly INcretin in diabetes (REWIND) trial on the cardiovascular effects of dulaglutide. Diabetes Obes Metab. 2018;20:42–49.
   Google Scholar
• Lilly E and Company. Trulicity® (dulaglutide) demonstrates superiority in reduction of cardiovascular events for broad range of people with type 2 diabetes [Internet].
   Google Scholar
• 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;52:2046–2055.
   Google Scholar