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: 52weeks of treatment in a randomized phase III study

Diabetes, Obesity and Metabolism

Volumn 18, Issue 3, 2016, Pages 249-257

  Odawara, M ^a   Miyagawa, J ^b   Iwamoto, N ^c   Takita, Y ^c   Imaoka, T ^c   Takamura, T ^d  

^a TOKYO MEDICAL UNIVERSITY   (Japan)

^b HYOGO COLLEGE OF MEDICINE   (Japan)

^c ELI LILLY AND COMPANY   (United States)

^d KANAZAWA UNIVERSITY GRADUATE SCHOOL OF MEDICAL SCIENCE   (Japan)

Author keywords

Dulaglutide; GLP 1 receptor agonist; Liraglutide; Type 2 diabetes

Indexed keywords

DULAGLUTIDE; GLUCOSE; HEMOGLOBIN A1C; LIRAGLUTIDE; PLACEBO; ANTIDIABETIC AGENT; GLUCAGON LIKE PEPTIDE; GLUCOSE BLOOD LEVEL; GLYCOSYLATED HEMOGLOBIN; HEMOGLOBIN A1C PROTEIN, HUMAN; HYBRID PROTEIN; IMMUNOGLOBULIN FC FRAGMENT;

ABDOMINAL DISTENSION; ADULT; AGED; ALLERGIC REACTION; ARTICLE; BODY WEIGHT; CIRCADIAN RHYTHM; CONSTIPATION; CONTROLLED STUDY; DECREASED APPETITE; DIARRHEA; DRUG DOSE TITRATION; DRUG EFFICACY; DRUG FATALITY; DRUG SAFETY; DRUG WITHDRAWAL; FEMALE; GLUCOSE BLOOD LEVEL; GLYCEMIC CONTROL; HUMAN; HYPOGLYCEMIA; INJECTION SITE REACTION; JAPANESE (PEOPLE); MAJOR CLINICAL STUDY; MALE; MONOTHERAPY; NAUSEA; NON INSULIN DEPENDENT DIABETES MELLITUS; PHASE 3 CLINICAL TRIAL; RANDOMIZED CONTROLLED TRIAL; RHINOPHARYNGITIS; SIDE EFFECT; TREATMENT DURATION; TREATMENT OUTCOME; ANALOGS AND DERIVATIVES; BLOOD; CHEMICALLY INDUCED; CLINICAL TRIAL; COMPARATIVE STUDY; DIABETES MELLITUS, TYPE 2; DOUBLE BLIND PROCEDURE; DRUG ADMINISTRATION; DRUG EFFECTS; JAPAN; MIDDLE AGED; POSTPRANDIAL STATE;

AGED; BLOOD GLUCOSE; BODY WEIGHT; DIABETES MELLITUS, TYPE 2; DOUBLE-BLIND METHOD; DRUG ADMINISTRATION SCHEDULE; FEMALE; GLUCAGON-LIKE PEPTIDES; HEMOGLOBIN A, GLYCOSYLATED; HUMANS; HYPOGLYCEMIA; HYPOGLYCEMIC AGENTS; IMMUNOGLOBULIN FC FRAGMENTS; JAPAN; LIRAGLUTIDE; MALE; MIDDLE AGED; POSTPRANDIAL PERIOD; RECOMBINANT FUSION PROTEINS; TREATMENT OUTCOME;

EID: 84957851776     PISSN: 14628902     EISSN: 14631326     Source Type: Journal    
DOI: 10.1111/dom.12602     Document Type: Article

References (30)

1. Byetta ([exenatide] injection) [prescribing information]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2015. Available from URL: http://www.azpicentral.com/byetta/pi_byetta.pdf. Accessed 10 July 2015.
2. Sanofi-Aventis Deutschland GmbH Lixisenatide (Lyxumia). Summary of product characteristics. EMA website. Available from URL: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/002445/WC500140401.pdf. Accessed 10 July 2015.
3. Victoza® (liraglutide [rDNA origin] injection, solution for subcutaneous use) [prescribing information]. Bagsvaerd, Denmark: Novo Nordisk A/S; 2015. Available from URL: http://www.novo-pi.com/victoza.pdf. Accessed 10 July 2015.
4. Bydureon® ([exenatide extended-release] for injectable suspension) [prescribing information]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2015. Available from URL: http://www.azpicentral.com/bydureon/pi_bydureon.pdf Accessed 10 July 2015.
5. Tanzeum ([albiglutide] for injection, for subcutaneous use) [prescribing information]. Wilmington, DE: GlaxoSmithKline LLC; 2015. Available from URL: https://gsksource.com/pharma/content/dam/GlaxoSmithKline/US/en/Prescribing_Information/Tanzeum/pdf/TANZEUM-PI-MG-IFU-COMBINED.PDF. Accessed 10 July 2015.
6. Trulicity® ([dulaglutide] injection, for subcutaneous use) [prescribing information]. Indianapolis, IN: Eli Lilly and Company; 2015. Available from URL: http://pi.lilly.com/us/trulicity-uspi.pdf. Accessed 10 July 2015.
7. Trulicity® [Summary of product characteristics]. Houten, The Netherlands: Eli Lilly and Company; 2015. Available from URL: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/002825/WC500179470.pdf. Accessed 10 July 2015.
8. Trulicity® Ateos® (dulaglutide [gene recombination] injection) [Japan package insert]. Hyogo, Japan: Eli Lilly Japan K.K.; 2015. Available from URL: http://www.info.pmda.go.jp/downfiles/ph/PDF/530471_2499416G1029_1_03.pdf (in Japanese). Accessed 13 October 2015.
9. Meier JJ. GLP-1 receptor agonists for individualized treatment of type 2 diabetes mellitus. Nat Rev Endocrinol 2012; 8: 728-742.
10. Johnston SS, Nguyen H, Felber E etal. Retrospective study of adherence to glucagon-like peptide-1 receptor agonist therapy in patients with type 2 diabetes mellitus in the United States. Adv Ther 2014; 31: 1119-1133.
11. Aroda VR, DeYoung MB. Clinical implications of exenatide as a twice-daily or once-weekly therapy for type 2 diabetes. Postgrad Med 2011; 123: 228-238.
12. Rosenstock J, Raccah D, Koranyi L etal. Efficacy and safety of lixisenatide once daily versus exenatide twice daily in type 2 diabetes inadequately controlled on metformin: a 24-week, randomized, open-label, active-controlled study (GetGoal-X). Diabetes Care 2013; 36: 2945-2951.
13. Buse JB, Rosenstock J, Sesti G etal. LEAD-6 Study Group. 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: 39-47.
14. Buse JB, Nauck M, Forst T etal. 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.
15. Pratley RE, Nauck MA, Barnett AH etal. 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 2014; 2: 289-297.
16. Wysham C, Blevins T, Arakaki R etal. Efficacy and safety of dulaglutide added on to pioglitazone and metformin versus exenatide in type 2 diabetes in a randomized controlled trial (AWARD-1). [Erratum appears in Diabetes Care 2014; 37: 2895]. Diabetes Care 2014; 37: 2159-2167.
17. Umpierrez G, Tofé Povedano S, Pérez 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: 2168-2176.
18. Nauck M, Weinstock RS, Umpierrez GE, Guerci B, Skrivanek Z, Milicevic Z. Efficacy and safety of dulaglutide versus sitagliptin after 52 weeks in type 2 diabetes in a randomized controlled trial (AWARD-5). Diabetes Care 2014; 37: 2149-2158.
19. 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: 2241-2249.
20. Dungan KM, Povedano ST, Forst T etal. 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. [Erratum appears in Lancet 2014; 384: 1348]. Lancet 2014; 384: 1349-1357.
21. Miyagawa J, Odawara M, Takamura T, Iwamoto N, Takita Y, Imaoka T. 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 Obes Metab 2015; 17: 974-983.
22. 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: 994-1002.
23. Ministry of Health, Labour and Welfare; 2010. On release of the guideline for clinical evaluation of oral hypoglycemic agents. Available from URL: https://www.pmda.go.jp/files/000208194.pdf. Accessed 22 September 2015.
24. World Medical Association. Declaration of Helsinki. Recommendations guiding physicians in biomedical research involving human subjects. JAMA 1997; 277: 925-926.
25. American Diabetes Association Workgroup on Hypoglycemia. Defining and reporting hypoglycemia in diabetes: a report from the American Diabetes Association Workgroup on Hypoglycemia. Diabetes Care 2005; 28: 1245-1249.
26. Seino Y, Rasmussen MF, Nishida T, Kaku K. 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 2010; 26: 1013-1022.
27. 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. Endocrine J 2015; 62: 1101-1114.
28. Russell-Jones D, Cuddihy RM, Hanefeld M etal. Efficacy and safety of exenatide once weekly versus metformin, pioglitazone, and sitagliptin used as monotherapy in drug-naïve patients with type 2 diabetes (DURATION-4): a 26-week double-blind study. Diabetes Care 2012; 35: 252-258.
29. Ferdinand KC, White WB, Calhoun DA etal. 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: 731-737.
30. Kaku K, Rasmussen MF, Clauson P, Seino Y. Improved glycaemic control with minimal hypoglycaemia 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 2010; 12: 341-347.