103
Views
19
CrossRef citations to date
0
Altmetric
Original Research

Safety and tolerability of exenatide twice daily in patients with type 2 diabetes: integrated analysis of 5594 patients from 19 placebo-controlled and comparator-controlled clinical trials

, , &
Pages 29-41 | Published online: 20 Feb 2012

References

  • Norris SL Lee N Thakurta S Chan BK Exenatide efficacy and safety: a systematic review Diabet Med 2009 26 9 837 846 19719703
  • Buse JB Henry RR Han J Effects of exenatide (exendin-4) on glycemic control over 30 weeks in sulfonylurea-treated patients with type 2 diabetes Diabetes Care 2004 27 11 2628 2635 15504997
  • DeFronzo RA Ratner RE Han J 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 15855572
  • Kendall DM Riddle MC Rosenstock J Effects of exenatide (exendin-4) on glycemic control over 30 weeks in patients with type 2 diabetes treated with metformin and a sulfonylurea Diabetes Care 2005 28 5 1083 1091 15855571
  • Heine RJ Van Gaal LF Johns D Exenatide versus insulin glargine in patients with suboptimally controlled type 2 diabetes: a randomized trial Ann Intern Med 2005 143 8 559 569 16230722
  • Zinman B Hoogwerf BJ Durán García S The effect of adding exenatide to a thiazolidinedione in suboptimally controlled type 2 diabetes: a randomized trial Ann Intern Med 2007 146 7 477 485 17404349
  • Barnett AH Burger J Johns D Tolerability and efficacy of exenatide and titrated insulin glargine in adult patients with type 2 diabetes previously uncontrolled with metformin or a sulfonylurea: a multinational, randomized, open-label, two-period, crossover noninferiority trial Clin Ther 2007 29 11 2333 2348 18158075
  • Davis SN Johns D Maggs D Exploring the substitution of exenatide for insulin in patients with type 2 diabetes treated with insulin in combination with oral antidiabetes agents Diabetes Care 2007 30 11 2767 2772 17595353
  • Nauck MA Duran S Kim D A comparison of twice-daily exenatide and biphasic insulin aspart in patients with type 2 diabetes who were suboptimally controlled with sulfonylurea and metformin: a non-inferiority study Diabetologia 2007 50 2 259 267 17160407
  • Gao Y Yoon KH Chuang L-M Efficacy and safety of exenatide in patients of Asian descent with type 2 diabetes inadequately controlled with metformin or metformin and a sulphonylurea Diabetes Res Clin Pract 2009 83 1 69 76 19019476
  • Kadowaki T Namba M Yamamura A Exenatide exhibits dose-dependent effects on glycemic control over 12 weeks in Japanese patients with suboptimally controlled type 2 diabetes Endocr J 2009 56 3 415 424 19194050
  • Moretto TJ Milton DR Ridge TD Efficacy and tolerability of exenatide monotherapy over 24 weeks in antidiabetic drug-naive patients with type 2 diabetes: a randomized, double-blind, placebo-controlled, parallel-group study Clin Ther 2008 30 8 1448 1460 18803987
  • Davies MJ Donnelly R Barnett AH Exenatide compared with long-acting insulin to achieve glycaemic control with minimal weight gain in patients with type 2 diabetes: results of the Helping Evaluate Exenatide in patients with diabetes compared with Long-Acting insulin (HEELA) study Diabetes Obes Metab 2009 11 12 1153 1162 19930005
  • DeFronzo RA Triplitt C Qu Y Effects of exenatide plus rosiglitazone on β-cell function and insulin sensitivity in subjects with type 2 diabetes on metformin Diabetes Care 2010 33 5 951 957 20107105
  • Gill A Hoogwerf BJ Burger J Effect of exenatide on heart rate and blood pressure in subjects with type 2 diabetes mellitus: a double-blind, placebo-controlled, randomized pilot study Cardiovasc Diabetol 2010 9 6 20109208
  • Apovian CM Bergenstal RM Cuddihy RM Effects of exenatide combined with lifestyle modification in patients with type 2 diabetes Am J Med 2010 123 5 468 e469 468 e417 20399326
  • Kadowaki T Mitsuyoshi N Imaoka T Improved glycemic control and reduced bodyweight with exenatide: a double-blind, randomized, phase 3 study in Japanese patients with suboptimally controlled type 2 diabetes over 24 weeks J Diabet Investig 2011 2 3 210 217
  • Liutkus J Rosas Guzman J Norwood P A placebo-controlled trial of exenatide twice-daily added to thiazolidinediones alone or in combination with metformin Diabetes Obes Metab 2010 12 12 1058 1065 20977576
  • Gallwitz B Böhmer M Segiet T Exenatide twice daily versus premixed insulin aspart 70/30 in metformin-treated patients with type 2 diabetes: a randomized 26-week study on glycemic control and hypoglycemia Diabetes Care 2011 34 3 604 606 21285388
  • Buse JB Bergenstal RM Glass LC Use of twice-daily exenatide in Basal insulin-treated patients with type 2 diabetes: a randomized, controlled trial Ann Intern Med 2011 154 2 103 112 21138825
  • World Medical Association World Medical Association Declaration of Helsinki: Recommendations guiding physicians in biomedical research involving human subjects JAMA 1997 277 11 925 926 9062334
  • Ratner R Han J Nicewarner D Cardiovascular safety of exenatide BID: an integrated analysis from controlled clinical trials in participants with type 2 diabetes Cardiovasc Diabetol 2011 10 22 21410975
  • Fineman M Mace K Diamant M Clinical relevance of anti-exenatide antibodies: safety, efficacy, and cross-reactivity with long-term treatment Diabetes Obes Metab 2012 [Epub ahead of print.]
  • Blonde L Klein EJ Han J Interim analysis of the effects of exenatide treatment on A1C, weight and cardiovascular risk factors over 82 weeks in 314 overweight patients with type 2 diabetes Diabetes Obes Metab 2006 8 4 436 447 16776751
  • Buse JB Klonoff DC Nielsen LL Metabolic effects of two years of exenatide treatment on diabetes, obesity, and hepatic biomarkers in patients with type 2 diabetes: an interim analysis of data from the open-label, uncontrolled extension of three double-blind, placebo-controlled trials Clin Ther 2007 29 1 139 153 17379054
  • Klonoff DC Buse JB Nielsen LL Exenatide effects on diabetes, obesity, cardiovascular risk factors and hepatic biomarkers in patients with type 2 diabetes treated for at least 3 years Curr Med Res Opin 2008 24 1 275 286 18053320
  • Riddle MC Henry RR Poon TH Exenatide elicits sustained glycaemic control and progressive reduction of body weight in patients with type 2 diabetes inadequately controlled by sulphonylureas with or without metformin Diabetes Metab Res Rev 2006 22 6 483 491 16634116
  • Nelson P Poon T Guan X The incretin mimetic exenatide as a monotherapy in patients with type 2 diabetes Diabetes Technol Ther 2007 9 4 317 326 17705687
  • Poon T Taylor K Nielsen L Effects of exenatide (synthetic exendin-4) on glucose control and safety in patients with type 2 diabetes treated with metformin, a sulfonylurea, or both: an ongoing, open-label phase 3 trial [Abstract] Diabet Med 2004 21 Suppl 2 13
  • Bytzer P Talley NJ Leemon M Prevalence of gastrointestinal symptoms associated with diabetes mellitus: a population-based survey of 15,000 adults Arch Intern Med 2001 161 16 1989 1996 11525701
  • Kim JH Park HS Ko SY Diabetic factors associated with gastrointestinal symptoms in patients with type 2 diabetes World J Gastroenterol 2010 16 14 1782 1787 20380013
  • Horowitz M Vilsbøll T Zdravkovic M Hammer M Madsbad S Patient-reported rating of gastrointestinal adverse effects during treatment of type 2 diabetes with the once-daily human GLP-1 analogue, liraglutide Diabetes Obes Metab 2008 10 7 593 596 18435773
  • Blonde L Russell-Jones D The safety and efficacy of liraglutide with or without oral antidiabetic drug therapy in type 2 diabetes: an overview of the LEAD 1–5 studies Diabetes Obes Metab 2009 11 Suppl 3 26 34 19878259
  • Bunck MC Diamant M Cornér A One-year treatment with exenatide improves β-cell function, compared with insulin glargine, in metformin-treated type 2 diabetic patients: a randomized, controlled trial Diabetes Care 2009 32 5 762 768 19196887
  • Ellero C Han J Bhavsar S Prophylactic use of anti-emetic medications reduced nausea and vomiting associated with exenatide treatment: a retrospective analysis of an open-label, parallel-group, single-dose study in healthy subjects Diabet Med 2010 27 10 1168 1173 20854385
  • McCall AL Cox DJ Brodows R Reduced daily risk of glycemic variability: comparison of exenatide with insulin glargine Diabetes Technol Ther 2009 11 6 339 344 19459761
  • Wright AD Cull CA Macleod KM Holman RR Hypoglycemia in type 2 diabetic patients randomized to and maintained on monotherapy with diet, sulfonylurea, metformin, or insulin for 6 years from diagnosis: UKPDS73 J Diabetes Complications 2006 20 6 395 401 17070446
  • Yadav D Lowenfels AB Trends in the epidemiology of the first attack of acute pancreatitis: a systematic review Pancreas 2006 33 4 323 330 17079934
  • Suazo-Baráhona J Carmona-Sánchez R Robles-Díaz G Obesity: a risk factor for severe acute biliary and alcoholic pancreatitis Am J Gastroenterol 1998 93 8 1324 1328 9707059
  • Papachristou GI Papachristou DJ Avula H Slivka A Whitcomb DC Obesity increases the severity of acute pancreatitis: performance of APACHE-O score and correlation with the inflammatory response Pancreatology 2006 6 4 279 285 16636600
  • Martínez J Johnson CD Sánchez-Payá J Obesity is a definitive risk factor of severity and mortality in acute pancreatitis: an updated meta-analysis Pancreatology 2006 6 3 206 209 16549939
  • Torgerson JS Lindroos AK Näslund I Peltonen M Gallstones, gall-bladder disease, and pancreatitis: cross-sectional and 2-year data from the Swedish Obese Subjects (SOS) and SOS reference studies Am J Gastroenterol 2003 98 5 1032 1041 12809825
  • Frossard JL Steer ML Pastor CM Acute pancreatitis Lancet 2008 371 9607 143 152 18191686
  • US Food and Drug Administration Information for Healthcare Professionals: Exenatide (marketed as Byetta), 8/2008 update Available from: http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm124713.htm Accessed January 1, 2012
  • US Food and Drug Administration Information for Healthcare-Professionals – Acute pancreatitis and sitagliptin (marketed as Januvia and Janumet) Available from: http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/ucm183764.htm Accessed January 1, 2012
  • Denker PS Dimarco PE Exenatide (exendin-4)-induced pancreatitis: a case report Diabetes Care 2006 29 2 471 16443920
  • Tripathy NR Basha S Jain R Shetty S Ramachandran A Exenatide and acute pancreatitis J Assoc Physicians India 2008 56 987 988 19322980
  • Ayoub WA Kumar AA Naguib HS Taylor HC Exenatide-induced acute pancreatitis Endocr Pract 2010 16 1 80 83 19703814
  • Dore DD Seeger JD Arnold Chan K Use of a claims-based active drug safety surveillance system to assess the risk of acute pancreatitis with exenatide or sitagliptin compared to metformin or glyburide Curr Med Res Opin 2009 25 4 1019 1027 19278373
  • Garg R Chen W Pendergrass M Acute pancreatitis in type 2 diabetes treated with exenatide or sitagliptin: a retrospective observational pharmacy claims analysis Diabetes Care 2010 33 11 2349 2354 20682680
  • Blomgren KB Sundström A Steineck G Wiholm BE Obesity and treatment of diabetes with glyburide may both be risk factors for acute pancreatitis Diabetes Care 2002 25 2 298 302 11815499
  • Fimognari FL Corsonello A Pastorell R Antonelli-Incalzi R Metformin-induced pancreatitis: a possible adverse drug effect during acute renal failure Diabetes Care 2006 29 5 1183 16644670
  • Gonzalez-Perez A Schlienger RG García Rodríguez LA Acute pancreatitis in association with type 2 diabetes and antidiabetic drugs: a population-based cohort study Diabetes Care 2010 33 12 2580 2585 20833867
  • Noel RA Braun DK Patterson RE Bloomgren GL Increased risk of acute pancreatitis and biliary disease observed in patients with type 2 diabetes: a retrospective cohort study Diabetes Care 2009 32 5 834 838 19208917
  • Girman CJ Kou TD Cai B Patients with type 2 diabetes mellitus have higher risk for acute pancreatitis compared with those without diabetes Diabetes Obes Metab 2010 12 9 766 771 20649628
  • Ferrer-Garcia JC Martinez-Chanza N Tolosa-Torréns M Sánchez-Juan C Exenatide and renal failure Diabet Med 2010 27 6 728 729 20546299
  • Weise WJ Sivanandy MS Block CA Comi RJ Exenatide-associated ischemic renal failure Diabetes Care 2009 32 2 e22 e23 19171732
  • Tuttle K Brown C Lee D Effect of exenatide BID on kidney function and adverse events in clinical trials Diabetes 2011 60 Suppl 1 A266
  • Copley K McCowen K Hiles R Investigation of exenatide elimination and its in vivo and in vitro degradation Curr Drug Metab 2006 7 4 367 374 16724926
  • Bjerre Knudsen L Madsen LW Andersen S Glucagon-like peptide-1 receptor agonists activate rodent thyroid C-cells causing calcitonin release and C-cell proliferation Endocrinology 2010 151 4 1473 1486 20203154
  • Buse JB Rosenstock J Sesti G Liraglutide once a day versus exenatide twice a day for type 2 diabetes: a 26-week randomised, parallel-group, multinational, open-label trial (LEAD-6) Lancet 2009 374 9683 39 47 19515413
  • Garber A Henry R Ratner R Liraglutide versus glimepiride monotherapy for type 2 diabetes (LEAD-3 Mono): a randomised, 52-week, phase III, double-blind, parallel-treatment trial Lancet 2009 373 9662 473 481 18819705
  • Hegedüs L Moses AC Zdravkovic M Le Thi T Daniels GH GLP-1 and calcitonin concentration in humans: lack of evidence of calcitonin release from sequential screening in over 5000 subjects with type 2 diabetes or nondiabetic obese subjects treated with the human GLP-1 analog, liraglutide J Clin Endocrinol Metab 2011 96 3 853 860 21209033
  • Best JH Hoogwerf BJ Herman WH Risk of cardiovascular disease events in patients with type 2 diabetes prescribed the glucagon-like peptide 1 (GLP-1) receptor agonist exenatide twice daily or other glucose-lowering therapies: a retrospective analysis of the LifeLink database Diabetes Care 2011 34 1 90 95 20929995
  • Russell-Jones D Vaag A Schmitz O 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 10 2046 2055 19688338
  • Buse JB Garber A Rosenstock J 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 6 1695 1702 21450987
  • Buse J Montanya E Sesti G Frequency and magnitude of antibody formation are lower with liraglutide than exenatide: LEAD-6 results [Abstract] Diabetes Care 2010 59 Suppl 1 184