Five-Year Efficacy and Safety Data of Exenatide Once Weekly: Long-term Results from the DURATION-1 Randomized Clinical Trial

Mayo Clinic Proceedings

Volumn 90, Issue 3, 2015, Pages 356-365

  Wysham, Carol H ^a   Macconell, Leigh A ^b   Maggs, David G ^c   Zhou, Ming ^b   Griffin, Peter S ^c   Trautmann, Michael E ^d  

^a Rockwood Clinic   (United States)

^b BRISTOL MYERS SQUIBB   (United States)

^c AMYLIN PHARMACEUTICALS INC   (United States)

^d Diabetes Research Group   (Germany)

Author keywords

Abbreviations and Acronyms BP blood pressure; FPG fasting plasma glucose; GLP 1RA glucagon like peptide 1 receptor agonist; HbA1c hemoglobin A1c; HDL C high density lipoprotein cholesterol; ITT intent to treat; LDL C low density lipoprotein cholesterol; LS least squares; T2DM type 2 diabetes mellitus

Indexed keywords

ALANINE AMINOTRANSFERASE; ASPARTATE AMINOTRANSFERASE; BIGUANIDE DERIVATIVE; EXENDIN 4; GLITAZONE DERIVATIVE; GLUCOSE; HEMOGLOBIN A1C; INSULIN DERIVATIVE; LIPID; ORAL ANTIDIABETIC AGENT; SULFONYLUREA DERIVATIVE; ANTIDIABETIC AGENT; GLUCOSE BLOOD LEVEL; GLYCOSYLATED HEMOGLOBIN; PEPTIDE; VENOM;

ACUTE KIDNEY FAILURE; ALANINE AMINOTRANSFERASE BLOOD LEVEL; ARTHRALGIA; ARTICLE; ASPARTATE AMINOTRANSFERASE BLOOD LEVEL; BACKACHE; BODY WEIGHT; BRONCHITIS; CONNECTIVE TISSUE DISEASE; CONTROLLED STUDY; COUGHING; DIARRHEA; DIASTOLIC BLOOD PRESSURE; DOSAGE SCHEDULE COMPARISON; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; GLOMERULUS FILTRATION RATE; GLUCOSE BLOOD LEVEL; HEADACHE; HEART DISEASE; HEART RATE; HEMOGLOBIN BLOOD LEVEL; HUMAN; HYPERTENSION; HYPOGLYCEMIA; INFECTION; INFESTATION; INJECTION SITE ERYTHEMA; INJECTION SITE NODULE; INJECTION SITE PRURITUS; INJECTION SITE REACTION; LIMB PAIN; LIPID BLOOD LEVEL; LONG TERM CARE; MAJOR CLINICAL STUDY; MUSCULOSKELETAL DISEASE; MUSCULOSKELETAL PAIN; NAUSEA; NON INSULIN DEPENDENT DIABETES MELLITUS; OPEN STUDY; PANCREAS CARCINOMA; PANCREATITIS; RANDOMIZED CONTROLLED TRIAL; RHINOPHARYNGITIS; SIDE EFFECT; SINUSITIS; TREATMENT DURATION; UPPER RESPIRATORY TRACT INFECTION; URINARY TRACT INFECTION; VIRAL GASTROENTERITIS; VOMITING; BLOOD PRESSURE; DIABETES MELLITUS, TYPE 2; DRUG EFFECTS; FEMALE; MALE; MIDDLE AGED; TREATMENT OUTCOME;

BLOOD GLUCOSE; BLOOD PRESSURE; BODY WEIGHT; DIABETES MELLITUS, TYPE 2; FEMALE; HEMOGLOBIN A, GLYCOSYLATED; HUMANS; HYPOGLYCEMIC AGENTS; MALE; MIDDLE AGED; PEPTIDES; TREATMENT OUTCOME; VENOMS;

EID: 84928428071     PISSN: 00256196     EISSN: 19425546     Source Type: Journal    
DOI: 10.1016/j.mayocp.2015.01.008     Document Type: Article

References (38)

1. DeFronzo RA. Banting Lecture. From the triumvirate to the ominous octet: A new paradigm for the treatment of type 2 diabetes mellitus. Diabetes. 2009;58(4):773-795.
2. Fonseca VA. Defining and characterizing the progression of type 2 diabetes. Diabetes Care. 2009;32(suppl 2):S151-S156.
3. Stratton IM, Adler AI, Neil HA, et al. Association of glycaemia with macrovascular and microvascular complications of type 2 diabetes (UKPDS 35): prospective observational study. BMJ. 2000;321(7258):405-412.
4. Kahn SE, Haffner SM, Heise MA, et al. Glycemic durability of rosiglitazone, metformin, or glyburide monotherapy. N Engl J Med. 2006;355(23):2427-2443.
5. Matthews DR, Cull CA, Stratton IM, Holman RR, Turner RC; UK Prospective Diabetes Study (UKPDS) Group. UKPDS 26: sulphonylurea failure in non-insulin-dependent diabetic patients over six years. Diabet Med. 1998;15(4):297-303.
6. Garber AJ, Abrahamson MJ, Barzilay JI, et al. AACE comprehensive diabetes management algorithm 2013. Endocr Pract. 2013; 19(2):327-336.
7. Inzucchi SE, Bergenstal RM, Buse JB, et al. Management of hyperglycemia in type 2 diabetes: A patient-centered approach: position statement of the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). Diabetes Care. 2012;35(6): 1364-1379.
8. Giugliano D, Maiorino MI, Bellastella G, Chiodini P, Esposito K. Multiple HbA1c targets and insulin analogues in type 2 diabetes: A systematic review. J Diabetes Complications. 2011;25(4):275-281.
9. Karl DM, Gill J, Zhou R, Riddle MC. Clinical predictors of risk of hypoglycaemia during addition and titration of insulin glargine for type 2 diabetes mellitus. Diabetes Obes Metab. 2013; 15(7):622-628.
10. Rosenstock J, Ahmann AJ, Colon G, Scism-Bacon J, Jiang H, Martin S. Advancing insulin therapy in type 2 diabetes previously treated with glargine plus oral agents: prandial premixed (insulin lispro protamine suspension/lispro) versus basal/bolus (glargine/lispro) therapy. Diabetes Care. 2008;31(1):20-25.
11. Henderson JN, Allen KV, Deary IJ, Frier BM. Hypoglycaemia in insulin-Treated type 2 diabetes: frequency, symptoms and impaired awareness. Diabet Med. 2003;20(12):1016-1021.
12. Pontiroli AE, Miele L, Morabito A. Increase of body weight during the first year of intensive insulin treatment in type 2 diabetes: systematic review and meta-Analysis. Diabetes Obes Metab. 2011;13(11):1008-1019
13. AstraZeneca. Bydureon Prescribing Information. 2014. http: //www.azpicentral.com/bydureon/pi-bydureon.pdf#page=1. Accessed October 10, 2014.
14. DeFronzo RA, Ratner RE, Han J, Kim DD, Fineman MS, Baron AD. Effects of exenatide (exendin-4) on glycemic control and weight over 30 weeks in metformin-Treated patients with type 2 diabetes. Diabetes Care. 2005;28(5):1092-1100.
15. 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(4):683-689.
16. Goke R, Fehmann HC, Linn T, et al. Exendin-4 is a high potency agonist and truncated exendin-(9-39)-Amide an antagonist at the glucagon-like peptide 1-(7-36)-Amide receptor of insulinsecreting beta-cells. J Biol Chem. 1993;268(26):19650-19655.
17. Gentilella R, Bianchi C, Rossi A, Rotella CM. Exenatide: A review from pharmacology to clinical practice. Diabetes Obes Metab. 2009;11(6):544-556.
18. Madsbad S, Kielgast U, Asmar M, Deacon CF, Torekov SS, Holst JJ. An overview of once-weekly glucagon-like peptide-1 receptor agonistseavailable efficacy and safety data and perspectives for the future. Diabetes Obes Metab. 2011;13(5):394-407.
19. AstraZeneca. Byetta Prescribing Information. 2014. http://www.azpicentral.com/byetta/pi-byetta.pdf#page=1. Accessed October 10, 2014.
20. 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(6):1255-1261.
21. 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(9645):1240-1250.
22. Taylor K, Gurney K, Han J, Pencek R, Walsh B, Trautmann M. Exenatide once weekly treatment maintained improvements in glycemic control and weight loss over 2 years. BMC Endocr Disord. 2011;11:9.
23. Macconell L, Pencek R, Li Y, Maggs D, Porter L. Exenatide once weekly: sustained improvement in glycemic control and cardiometabolic measures through 3 years. Diabetes Metab Syndr Obes. 2013;6:31-41.
24. 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): 204-212.
25. Home P, Stewart M, Mallory J, et al, eds. Harmony 5 year 3 results: Albiglutide vs. placebo and vs. pioglitazone in triple therapy (background metformin and glimepiride) in people with type 2 diabetes. Poster presented at: American Diabetes Association 74th Scientific Sessions; June 13-17, 2014; San Francisco, CA. Poster 963-P.
26. Weissman P, Stewart M, Cirkel D, Ye J, Ambery P, eds. Harmony 4: 3-year efficacy of albiglutide (albi) vs. insulin glargine (glar) in patients with T2DM. Poster presented at: American Diabetes Association 74th Scientific Sessions; June 13-17, 2014; San Francisco, CA. Poster 961-P.
27. Bode BW, Stewart M, Cirkel D, et al, eds. Harmony 1 year 3 results: Albiglutide vs. placebo in patients with type 2 diabetes mellitus not controlled on pioglitazone (pio) metformin (met). Poster presented at: American Diabetes Association 74th Scientific Sessions; June 13-17, 2014; San Francisco, CA. Poster 960-P.
28. Hemming K, Hutton JL, Maguire MJ, Marson AG. Open label extension studies and patient selection biases. J Eval Clin Pract. 2008;14(1):141-144.
29. Taylor GJ, Wainwright P. Open label extension studies: research or marketing? BMJ. 2005;331(7516):572-574.
30. Ajala O, English P, Pinkney J. Systematic review and metaanalysis of different dietary approaches to the management of type 2 diabetes. Am J Clin Nutr. 2013;97(3):505-516.
31. Diabetes Prevention Program Outcomes Study Research Group, Orchard TJ, Temprosa M, Barrett-Connor E, et al. Long-Term effects of the Diabetes Prevention Program interventions on cardiovascular risk factors: A report from the DPP Outcomes Study. Diabet Med. 2013;30(1):46-55.
32. Hanefeld M, Bramlage P. Insulin use early in the course of type 2 diabetes mellitus: The ORIGIN trial. Curr Diab Rep. 2013; 13(3):342-349.
33. Reaney M, Mathieu C, Ostenson CG, et al. Patient-reported outcomes among patients using exenatide twice daily or insulin in clinical practice in six European countries: The CHOICE prospective observational study. Health Qual Life Outcomes. 2013; 11:217.
34. Wadden TA, Webb VL, Moran CH, Bailer BA. Lifestyle modification for obesity: new developments in diet, physical activity, and behavior therapy. Circulation. 2012;125(9):1157-1170.
35. UK Hypoglycaemia Study Group. Risk of hypoglycaemia in types 1 and 2 diabetes: effects of treatment modalities and their duration. Diabetologia. 2007;50(6):1140-1147.
36. Zammitt NN, Frier BM. Hypoglycemia in type 2 diabetes: pathophysiology, frequency, and effects of different treatment modalities. Diabetes Care. 2005;28(12):2948-2961.
37. Viana LV, Leitao CB, Grillo MF, et al. Hypertension management algorithm for type 2 diabetic patients applied in primary care. Diabetol Metab Syndr. 2013;5(1):52.
38. Diamant M, Van Gaal L, 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(6):464-473.