Efficacy and safety profile of once-weekly dulaglutide in type 2 diabetes: a report on the emerging new data

References

• Barrington P Chien JY Showalter HDH A 5-week study of the pharmacokinetics and pharmacodynamics of LY2189265, a novel, long-acting glucagon-like peptide-1 analogue, in patients with type 2 diabetes Diabetes Obes Metab 2011 13 5 426 433 21251178
   PubMed Web of Science ®Google Scholar
• Gurung T Shyangdan DS O’Hare JP Waugh N A novel, long-acting glucagon-like peptide receptor-agonist: dulaglutide Diabetes Metab Syndr Obes 2015 8 363 386 26316788
   PubMed Web of Science ®Google Scholar
• Jendle J Grunberger G Blevins T Giorgino F Hietpas RT Botros FT Efficacy and safety of dulaglutide in the treatment of type 2 diabetes: a comprehensive review of the dulaglutide clinical data focusing on the AWARD phase 3 clinical trial program Diabetes Metab Res Rev 2016 32 8 776 790 27102969
   PubMed Web of Science ®Google Scholar
• Thompson AM Trujillo JM Advances in the treatment of type 2 diabetes: impact of dulaglutide Diabetes Metab Syndr Obes 2016 9 125 136 27217788
   PubMed Web of Science ®Google Scholar
• Scheen AJ Dulaglutide for the treatment of type 2 diabetes Expert Opin Biol Ther 2017 17 4 485 496 28274140
   PubMed Web of Science ®Google Scholar
• Trulicity (dulaglutide) injection, solution [prescribing information] Indianapolis, IN Eli Lilly and Company 2017
   Google Scholar
• Trulicity (dulaglutide) injection, solution [medication guide] Indianapolis, IN Eli Lilly and Company 2017
   Google Scholar
• Umpierrez G Tofe Povedano S Perez Manghi F Shurzinske L Pechtner V Efficacy and safety of dulaglutide monotherapy versus metformin in type 2 diabetes in a randomized controlled trial (AWARD-3) Diabetes Care 2014 37 8 2168 2176 24842985
   PubMed Web of Science ®Google Scholar
• Weinstock RS Guerci B Umpierrez G Nauck MA Skrivanek Z Milicevic Z Safety and efficacy of once-weekly dulaglutide versus sitagliptin after 2 years in metformin-treated patients with type 2 diabetes (AWARD-5): a randomized, phase III study Diabetes Obes Metab 2015 17 9 849 858 25912221
   PubMed Web of Science ®Google Scholar
• Emoto M Terauchi Y Ozeki A Oura T Takeuchi M Imaoka T A 1-year safety study of dulaglutide in Japanese patients with type 2 diabetes on a single oral hypoglycemic agent: an open-label, nonrandomized, phase 3 trial Endocr J 2015 62 12 1101 1114 26477324
   PubMed Web of Science ®Google Scholar
• Wysham C Blevins T Arakaki R Efficacy and safety of dulaglutide added onto pioglitazone and metformin versus exenatide in type 2 diabetes in a randomized controlled trial (AWARD-1) Diabetes Care 2014 37 8 2159 2167 24879836
   PubMed Web of Science ®Google Scholar
• Dungan KM Povedano ST Forst T Once-weekly dulaglutide versus once-daily liraglutide in metformin-treated patients with type 2 diabetes (AWARD-6): a randomised, open-label, phase 3, non-inferiority trial Lancet 2014 384 9951 1349 1357 25018121
   PubMed Web of Science ®Google Scholar
• Odawara M Miyagawa J Iwamoto N Takita Y Imaoka T Takamura T Once-weekly glucagon-like peptide-1 receptor agonist dulaglutide significantly decreases glycated haemoglobin compared with once-daily liraglutide in Japanese patients with type 2 diabetes: 52 weeks of treatment in a randomized phase III study Diabetes Obes Metab 2016 18 3 249 257 26661514
   PubMed Web of Science ®Google Scholar
• Giorgino F Benroubi M Sun JH Zimmermann AG Pechtner V Efficacy and safety of once-weekly dulaglutide versus insulin glargine in patients with type 2 diabetes on metformin and glimepiride (AWARD-2) Diabetes Care 2015 38 12 2241 2249 26089386
   PubMed Web of Science ®Google Scholar
• Blonde L Jendle J Gross J Once-weekly dulaglutide versus bedtime insulin glargine, both in combination with prandial insulin lispro, in patients with type 2 diabetes (AWARD-4): a randomised, open-label, phase 3, non-inferiority study Lancet 2015 385 9982 2057 2066 26009229
   PubMed Web of Science ®Google Scholar
• Araki E Inagaki N Tanizawa Y Oura T Takeuchi M Imaoka T Efficacy and safety of once-weekly dulaglutide in combination with sulphonylurea and/or biguanide compared with once-daily insulin glargine in Japanese patients with type 2 diabetes: a randomized, open-label, phase III, non-inferiority study Diabetes Obes Metab 2015 17 10 994 1002 26179754
   PubMed Web of Science ®Google Scholar
• Pozzilli P Norwood P Jodar E Placebo-controlled, randomized trial of the addition of once-weekly glucagon-like peptide-1 receptor agonist dulaglutide to titrated daily insulin glargine in patients with type 2 diabetes (AWARD-9) Diabetes Obes Metab 2017 19 7 1024 1031 28294499
   PubMed Web of Science ®Google Scholar
• Dungan KM Weitgasser R Perez Manghi F A 24-week study to evaluate the efficacy and safety of once-weekly dulaglutide added on to glimepiride in type 2 diabetes (AWARD-8) Diabetes Obes Metab 2016 18 5 475 482 26799540
   PubMed Web of Science ®Google Scholar
• Monami M Zannoni S Pala L Effects of glucagon-like peptide-1 receptor agonists on mortality and cardiovascular events: a comprehensive meta-analysis of randomized controlled trials Int J Cardiol 2017 240 414 421 28501352
   PubMed Web of Science ®Google Scholar
• Ferdinand KC Botros FT Atisso CM Sager PT Cardiovascular safety for once-weekly dulaglutide in type 2 diabetes: a pre-specified meta-analysis of prospectively adjudicated cardiovascular events Cardiovasc Diabetol 2016 15 1 38 26912057
   PubMed Web of Science ®Google Scholar
• Eli Lilly and Company Researching cardiovascular events with a weekly incretin in diabetes (REWIND) Bethesda, MD National Library of Medicine 2011–2013 Available from: clinicaltrials.gov. NLM Identifier: NCT01394952 Accessed March 22, 2018
   Google Scholar
• Sun F Wu S Guo S Impact of GLP-1 receptor agonists on blood pressure, heart rate and hypertension among patients with type 2 diabetes: a systematic review and network meta-analysis Diabetes Res Clin Pract 2015 110 1 26 37 26358202
   PubMed Web of Science ®Google Scholar
• Ferdinand KC White WB Calhoun DA Effects of the once-weekly glucagon-like peptide-1 receptor agonist dulaglutide on ambulatory blood pressure and heart rate in patients with type 2 diabetes mellitus Hypertension 2014 64 4 731 737 24980665
   PubMed Web of Science ®Google Scholar
• Davidson JA Manghi FP Yu M Linetzky B Lando LF Efficacy and safety of dulaglutide in Hispanic/Latino patients with type 2 diabetes in the AWARD clinical program Endocr Pract 2016 22 12 1406 1414 27540883
   PubMed Web of Science ®Google Scholar
• Hamano K Nishiyama H Matsui A Sato M Takeuchi M Efficacy and safety analyses across 4 subgroups combining low and high age and body mass index groups in Japanese phase 3 studies of dulaglutide 0.75 mg after 26 weeks of treatment Endocr J 2017 64 4 449 456 28302958
   PubMed Web of Science ®Google Scholar
• Onishi Y Oura T Matsui A Matsuura J Iwamoto N Analysis of efficacy and safety of dulaglutide 0.75 mg stratified by sex in patients with type 2 diabetes in 2 randomized, controlled phase 3 studies in Japan Endocr J 2017 64 5 553 560 28367916
   PubMed Web of Science ®Google Scholar
• Zhang L Zhang M Zhang Y Tong N Efficacy and safety of dulaglutide in patients with type 2 diabetes: a meta-analysis and systematic review Sci Rep 2016 6 18904 26742577
   PubMed Web of Science ®Google Scholar
• Onishi Y Oura T Nishiyama H Ohyama S Takeuchi M Iwamoto N Subgroup analysis of phase 3 studies of dulaglutide in Japanese patients with type 2 diabetes Endocr J 2016 63 3 263 273 26698689
   PubMed Web of Science ®Google Scholar
• Zaccardi F Htike ZZ Webb DR Khunti K Davies MJ Benefits and harms of once-weekly glucagon-like peptide-1 receptor agonist treatments: a systematic review and network meta-analysis Ann Intern Med 2016 164 2 102 113 26642233
   PubMed Web of Science ®Google Scholar
• Nauck MA Frossard JL Barkin JS Assessment of pancreas safety in the development program of once-weekly GLP-1 receptor agonist dulaglutide Diabetes Care 2017 40 5 647 654 28283565
   PubMed Web of Science ®Google Scholar
• Emoto M Oura T Matsui A Kazama H Iwamoto N Pancreatic safety in Japanese patients with type 2 diabetes treated with once weekly dulaglutide 0.75 mg up to 52 weeks in phase 3 clinical trials Endocr J 2017 64 2 191 206 27853058
   PubMed Web of Science ®Google Scholar
• Guo X Yang Q Dong J Liao L Zhang W Liu F Tumour risk with once-weekly glucagon-like peptide-1 receptor agonists in type 2 diabetes mellitus patients: a systematic review Clin Drug Investig 2016 36 6 433 441
   PubMed Web of Science ®Google Scholar
• Bettge K Kahle M Abd El Aziz MS Meier JJ Nauck MA Occurrence of nausea, vomiting and diarrhoea reported as adverse events in clinical trials studying glucagon-like peptide-1 receptor agonists: a systematic analysis of published clinical trials Diabetes Obes Metab 2017 19 3 336 347 27860132
   PubMed Web of Science ®Google Scholar
• Dicembrini I Nreu B Scatena A Microvascular effects of glucagon-like peptide-1 receptor agonists in type 2 diabetes: a meta-analysis of randomized controlled trials Acta Diabetol 2017 54 10 933 941 28748377
   PubMed Web of Science ®Google Scholar
• Mann JFE Orsted DD Buse JB Liraglutide and renal outcomes in type 2 diabetes N Engl J Med 2017 377 22 2197 2198 29171823
   PubMedGoogle Scholar
• Grunberger G Forst T Fernandez Lando L Early fasting glucose measurements can predict later glycaemic response to once weekly dulaglutide Diabet Med 2016 33 3 391 394 26179454
   PubMed Web of Science ®Google Scholar
• Wysham C Guerci B D’Alessio D Jia N Botros FT Baseline factors associated with glycaemic response to treatment with once-weekly dulaglutide in patients with type 2 diabetes Diabetes Obes Metab 2016 18 11 1138 1142 27265893
   PubMed Web of Science ®Google Scholar
• Reaney M Yu M Lakshmanan M Pechtner V van Brunt K Treatment satisfaction in people with type 2 diabetes mellitus treated with once-weekly dulaglutide: data from the AWARD-1 and AWARD-3 clinical trials Diabetes Obes Metab 2015 17 9 896 903 26095190
   PubMed Web of Science ®Google Scholar
• Yu M Van Brunt K Varnado OJ Boye KS Patient-reported outcome results in patients with type 2 diabetes treated with once-weekly dulaglutide: data from the AWARD phase III clinical trial programme Diabetes Obes Metab 2016 18 4 419 424 26691396
   PubMed Web of Science ®Google Scholar
• Suzuki S Oura T Takeuchi M Boye KS Evaluation of the impact of once weekly dulaglutide on patient-reported outcomes in Japanese patients with type 2 diabetes: comparisons with liraglutide, insulin glargine, and placebo in two randomized studies Health Qual Life Outcomes 2017 15 1 123 28606095
   PubMed Web of Science ®Google Scholar
• American Diabetes Association Pharmacologic approaches to glycemic treatment: standards of medical care in diabetes – 2018 Diabetes Care 2018 41 suppl 1 S73 S85 29222379
   PubMed Web of Science ®Google Scholar
• Marso SP Daniels GH Brown-Frandsen K Liraglutide and cardiovascular outcomes in type 2 diabetes N Engl J Med 2016 375 4 311 322 27295427
   PubMed Web of Science ®Google Scholar
• Marso SP Bain SC Consoli A Semaglutide and cardiovascular outcomes in patients with type 2 diabetes N Engl J Med 2016 375 19 1834 1844 27633186
   PubMed Web of Science ®Google Scholar
• Holman RR Bethel MA Mentz RJ Effects of once-weekly exenatide on cardiovascular outcomes in type 2 diabetes N Engl J Med 2017 377 13 1228 1239 28910237
   PubMed Web of Science ®Google Scholar
• Zinman B Wanner C Lachin JM Empagliflozin, cardiovascular outcomes, and mortality in type 2 diabetes N Engl J Med 2015 373 22 2117 2128 26378978
   PubMed Web of Science ®Google Scholar
• Neal B Perkovic V Matthews DR Canagliflozin and cardiovascular and renal events in type 2 diabetes N Engl J Med 2017 377 21 644 657 28605608
   PubMed Web of Science ®Google Scholar
• Trulicity (dulaglutide) injection, solution [instructions for use] Indianapolis, IN Eli Lilly and Company 2016
   Google Scholar