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

Endocrine Journal

Volumn 62, Issue 12, 2015, Pages 1101-1114

  Emoto, Masanori ^a   Terauchi, Yasuo ^b   Ozeki, Akichika ^c   Oura, Tomonori ^c   Takeuchi, Masakazu ^c   Imaoka, Takeshi ^c  

^a OSAKA CITY UNIVERSITY GRADUATE SCHOOL OF MEDICINE   (Japan)

^b YOKOHAMA CITY UNIVERSITY   (Japan)

^c ELI LILLY AND COMPANY   (United States)

Author keywords

Dulaglutide; GLP 1 receptor agonist; Phase 3 study; Type 2 diabetes

Indexed keywords

ALPHA GLUCOSIDASE INHIBITOR; AMYLASE; BIGUANIDE DERIVATIVE; DULAGLUTIDE; GLITAZONE DERIVATIVE; MITIGLINIDE; ORAL ANTIDIABETIC AGENT; SULFONYLUREA DERIVATIVE; TRIACYLGLYCEROL LIPASE; ANTIDIABETIC AGENT; GLUCAGON LIKE PEPTIDE; GLUCAGON LIKE PEPTIDE 1 RECEPTOR; GLYCOSYLATED HEMOGLOBIN; HYBRID PROTEIN; IMMUNOGLOBULIN FC FRAGMENT;

ACUTE HEART INFARCTION; ADULT; ARTICLE; BACKACHE; BILE DUCT STONE; BODY WEIGHT DISORDER; BRONCHITIS; CHOLANGITIS; COMBINATION CHEMOTHERAPY; CONGESTIVE HEART FAILURE; CONSTIPATION; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CONTUSION; DECREASED APPETITE; DIARRHEA; DISEASE SEVERITY; DRUG EFFICACY; DRUG SAFETY; DYSPEPSIA; EDEMA; FEMALE; GASTROINTESTINAL DISEASE; GLYCEMIC CONTROL; HEART MUSCLE ISCHEMIA; HUMAN; HYPERTENSION; HYPOGLYCEMIA; INCIDENCE; INFLUENZA; JAPANESE (PEOPLE); MAJOR CLINICAL STUDY; MALE; NAUSEA; NON INSULIN DEPENDENT DIABETES MELLITUS; OPEN STUDY; OVARY CANCER; PHARYNGITIS; PHASE 3 CLINICAL TRIAL; PULSE RATE; RHINOPHARYNGITIS; STOMACH ADENOCARCINOMA; TREATMENT DURATION; VOMITING; WEIGHT CHANGE; AGED; AGONISTS; ANALOGS AND DERIVATIVES; BLOOD; BODY WEIGHT; CHEMICALLY INDUCED; CLINICAL TRIAL; DIABETES MELLITUS, TYPE 2; JAPAN; MIDDLE AGED; MULTICENTER STUDY;

ADULT; AGED; BODY WEIGHT; DIABETES MELLITUS, TYPE 2; FEMALE; GASTROINTESTINAL DISEASES; GLUCAGON-LIKE PEPTIDE-1 RECEPTOR; GLUCAGON-LIKE PEPTIDES; HEMOGLOBIN A, GLYCOSYLATED; HUMANS; HYPOGLYCEMIA; HYPOGLYCEMIC AGENTS; IMMUNOGLOBULIN FC FRAGMENTS; JAPAN; MALE; MIDDLE AGED; NASOPHARYNGITIS; RECOMBINANT FUSION PROTEINS;

EID: 84952014744     PISSN: 09188959     EISSN: 13484540     Source Type: Journal    
DOI: 10.1507/endocrj.EJ15-0401     Document Type: Article

References (33)

1. MacDonald PE, El-Kholy W, Riedel MJ, Salapatek AM, Light PE, et al. (2002) The multiple actions of GLP-1 on the process of glucose-stimulated insulin secretion. Diabetes 51 Suppl 3:S434-S442.
2. Gutzwiller JP, Degen L, Heuss L, Beglinger C (2004) Glucagon-like peptide 1 (GLP-1) and eating. Physiol Behav 82:17-19.
3. Mudaliar S, Henry RR (2009) Incretin therapies: effects beyond glycemic control. Am J Med 122:S25-S36.
4. Madsbad S, Kielgast U, Asmar M, Deacon CF, Torekov SS, et al. (2011) An overview of once-weekly glucagonlike peptide-1 receptor agonists-available efficacy and safety data and perspectives for the future. Diabetes Obes Metab 13:394-407.
5. Lorenz M, Evers A, Wagner M (2013) Recent progress and future options in the development of GLP-1 receptor agonists for the treatment of diabesity. Bioorg Med Chem Lett 23:4011-4018.
6. Lund A, Knop FK, Vilsb0ll T (2014) Glucagon-like peptide-1 receptor agonists for the treatment of type 2 diabetes: differences and similarities. Eur J Intern Med 25:407-414.
7. Victoza [Japan package insert]. Tokyo Japan: Novo Nordisk Pharma Ltd 2014. Available from http://www.info.pmda.go.jp/downfiles/ph/PDF/620023_2499410G1021_1_08.pdf (In Japanese). Accessed 16 June 2015.
8. Byetta [Japan package insert], Osaka Japan: AstraZeneca K.K.2015. Available from http://www.info.pmda.go.jp/downfiles/ph/PDF/670227_2499411G1026_2_04.pdf (In Japanese). Accessed 16 June 2015.
9. Bydureon [Japan package insert]. Osaka Japan: AstraZeneca K.K. 2015. Available from http://www.info.pmda.go.jp/downfiles/ph/PDF/ 670227_2499411G3029_1_11.pdf (In Japanese). Accessed 16 June 2015.
10. Lyxumia [Japan package insert]. Tokyo Japan: Sanofi K.K. 2014. Available from http://www.info.pmda.go.jp/downfiles/ph/PDF/780069_2499415G1024_1_04.pdf (In Japanese). Accessed 16 June 2015.
11. Trulicity [Prescribing Information]. Indianapolis, IN: Lilly USA, LLC 2014. Available from http://pi.lilly.com/us/trulicity-uspi.pdf Accessed 16 June 2015.
12. Trulicity [Summary of Product Characteristics]. Houten, The Netherlands: Eli Lilly and Company 2015. Available from http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/002825/WC500179470.pdf Accessed 24 September 2015.
13. Trulicity Ateos [Japan package insert]. Hyogo Japan: Eli Lilly Japan K.K. 2015. Available from http:// www.info.pmda.go.jp/downfiles/ph/PDF/530471_ 2499416G1029_1_03.pdf (In Japanese). Accessed 24 September 2015.
14. Glaesner W, Vick AM, Millican R, Ellis B, Tschang SH, et al. (2010) Engineering and characterization of the long-acting glucagon-like peptide-1 analogue LY2189265, an Fc fusion protein. Diabetes Metab Res Rev 26:287-296.
15. Umpierrez G, Tofe Povedano S, Perez Manghi F, Shurzinske L, Pechtner V (2014) Efficacy and safety of dulaglutide monotherapy versus metformin in type 2 diabetes in a randomized controlled trial (AWARD-3). Diabetes Care 37:2168-2176.
16. Nauck M, Weinstock RS, Umpierrez GE, Guerci B, Skrivanek Z, et al. (2014) Efficacy and safety of dula- glutide versus sitagliptin after 52 weeks in type 2 diabetes in a randomized controlled trial (AWARD-5). Diabetes Care 37:2149-2158.
17. Giorgino F, Benroubi M, Sun JH, Zimmermann AG, Pechtner V (2015) Efficacy and safety of once-weekly dulaglutide versus insulin glargine in patients with type 2 diabetes on metformin and glimepiride (AWARD-2). Diabetes Care 38:2241-2249.
18. Wysham C, Blevins T, Arakaki R, Colon G, Garcia P, et al. (2014) Efficacy and safety of dulaglutide added on to pioglitazone and metformin versus exenatide in type 2 diabetes in a randomized controlled trial (AWARD-1). Diabetes Care 37:2159-2167.
19. Dungan KM, Povedano ST, Forst T, Gonzalez JG, Atisso C, et al. (2014) 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 384:1349-1357.
20. Miyagawa J, Odawara M, Takamura T, Iwamoto N, Takita Y, et al. (2015) Once weekly glucagon-like peptide-1 receptor agonist dulaglutide is non-inferior to once daily liraglutide and superior to placebo in Japanese patients with type 2 diabetes: a 26-week randomized phase III study. Diabetes ObesMetab 17:974-983.
21. Araki E, Inagaki N, Tanizawa Y, Oura T, Takeuchi M, et al. (2015) Efficacy and safety of once weekly dula- glutide in combination with sulphonylurea and/or big- uanide 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 17:994-1002.
22. Ministry of Health, Labour and Welfare (2010) On release of the Guideline for Clinical Evaluation of Oral Hypoglycemic Agents. Available from https://www. pmda.go.jp/files/000208194.pdf Accessed 16 June 2015.
23. Workgroup on Hypoglycemia, American Diabetes Association (2005) Defining and reporting hypoglycemia in diabetes: a report from the American Diabetes Association Workgroup on Hypoglycemia. Diabetes Care 28:1245-1249.
24. Wallace TM, Levy JC, Matthews DR (2004) Use and abuse of HOMA modeling. Diabetes Care 27:1487-1495.
25. Seino Y, Rasmussen MF, Nishida T, Kaku K (2010) Efficacy and safety of the once-daily human GLP-1 analogue, liraglutide, vs glibenclamide monotherapy in Japanese patients with type 2 diabetes. Curr Med Res Opin 26:1013-1022.
26. Kadowaki T, Namba M, Imaoka T, Yamamura A, Goto W, et al. (2011) Improved glycemic control and reduced bodyweight with exenatide: a double-blind, randomized, phase 3 study in Japanese patients with subop- timally controlled type 2 diabetes over 24 weeks. J Diabetes Investig 2:210-217.
27. Ji L, Onishi Y, Ahn CW, Agarwal P, Chou CW, et al. (2013) Efficacy and safety of exenatide once weekly vs exenatide twice-daily in Asian patients with type 2 diabetes mellitus. J Diabetes Investig 4:53-61.
28. Inagaki N, Atsumi Y, Oura T, Saito H, Imaoka T (2012) Efficacy and safety profile of exenatide once weekly compared with insulin once daily in Japanese patients with type 2 diabetes treated with oral antidiabetes drug(s): results from a 26-week, randomized, open- label, parallel-group, multicenter, noninferiority study. Clin Ther 34:1892-1908.
29. Seino Y, Mm KW, Niemoeller E, Takami A; EFC10887 GETGOAL-L Asia Study Investigators (2012) Randomized, double-blind, placebo-controlled trial of the once-daily GLP-1 receptor agonist lixisenatide in Asian patients with type 2 diabetes insufficiently controlled on basal insulin with or without a sulfonylurea (GetGoal-L-Asia). Diabetes ObesMetab 14:910-917.
30. Kaku K, Rasmussen MF, Clauson P, Seino Y (2010) Improved glycaemic control with minimal hypoglycae- mia and no weight change with the once-daily human glucagon-like peptide-1 analogue liraglutide as add-on to sulphonylurea in Japanese patients with type 2 diabetes. Diabetes Obes Metab 12:341-347.
31. Japan Diabetes Society (2011) Committee on the proper use of incretin drugs (GLP-1 receptor agonists and DPP-4 inhibitors). Available from http://www.jds.or.jp/uploads/photos/797.pdf (In Japanese). Accessed 16 June 2015.
32. Pratley RE, Nauck MA, Barnett AH, Feinglos MN, Ovalle F, et al. (2014) Once-weekly albiglutide versus once-daily liraglutide in patients with type 2 diabetes inadequately controlled on oral drugs (HARMONY 7): a randomised, open-label, multicentre, non-inferiority phase 3 study. Lancet Diabetes Endocrinol 2:289-297.
33. Pharmaceuticals and Medical Devices Agency (2014) Review report for new indication of liraglutide (Victoza). http://www.pmda.go.jp/drugs/2014/P201400122A520023000_22200AMX00236_A100_1.pdf (In Japanese). Accessed 28 July 2015.