Efficacy and safety of once- weekly dulaglutide versus insulin glargine in patients with type 2 Diabetes on metformin and glimepiride (AWARD-2)

Diabetes Care

Volumn 38, Issue 12, 2015, Pages 2241-2249

  Giorgino, Francesco ^a   Benroubi, Marian ^b   Sun, Jui Hung ^c   Zimmermann, Alan G ^d   Pechtner, Valeria ^d  

^a UNIVERSITY OF BARI   (Italy)

^b IASO GENERAL HOSPITAL   (Greece)

^c CHANG GUNG MEMORIAL HOSPITAL   (Taiwan)

^d ELI LILLY AND COMPANY   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

DULAGLUTIDE; GLIMEPIRIDE; HEMOGLOBIN A1C; INSULIN GLARGINE; METFORMIN; ANTIDIABETIC AGENT; GLUCAGON LIKE PEPTIDE; GLUCOSE BLOOD LEVEL; GLYCOSYLATED HEMOGLOBIN; HYBRID PROTEIN; IMMUNOGLOBULIN FC FRAGMENT; SULFONYLUREA DERIVATIVE;

ABDOMINAL PAIN; ADULT; AFRICAN AMERICAN; AMERICAN INDIAN; ANALYSIS OF VARIANCE; ARTICLE; ASIAN; BRONCHITIS; CAUCASIAN; CONTROLLED STUDY; DIARRHEA; DISEASE SEVERITY; DRUG EFFICACY; DRUG SAFETY; DRUG SOLUBILITY; DRUG TOLERABILITY; DYSPEPSIA; ETHNICITY; FEMALE; GLUCOSE BLOOD LEVEL; GLYCEMIC CONTROL; HEADACHE; HEMOGLOBIN BLOOD LEVEL; HUMAN; IMMUNOGENICITY; INFECTION; INFLUENZA; MAJOR CLINICAL STUDY; MALE; NAUSEA; NEUROLOGIC DISEASE; NON INSULIN DEPENDENT DIABETES MELLITUS; RANDOMIZED CONTROLLED TRIAL; RHINOPHARYNGITIS; RISK ASSESSMENT; UPPER ABDOMINAL PAIN; UPPER RESPIRATORY TRACT INFECTION; URINARY TRACT INFECTION; VOMITING; WEIGHT REDUCTION; AGED; ANALOGS AND DERIVATIVES; ANALYSIS; BLOOD; CHEMICALLY INDUCED; CLINICAL TRIAL; DIABETES MELLITUS, TYPE 2; DOUBLE BLIND PROCEDURE; DRUG EFFECTS; GASTROINTESTINAL DISEASE; HYPOGLYCEMIA; MIDDLE AGED; MULTICENTER STUDY; TREATMENT OUTCOME;

AGED; BLOOD GLUCOSE; DIABETES MELLITUS, TYPE 2; DOUBLE-BLIND METHOD; FEMALE; GASTROINTESTINAL DISEASES; GLUCAGON-LIKE PEPTIDES; HEMOGLOBIN A, GLYCOSYLATED; HUMANS; HYPOGLYCEMIA; HYPOGLYCEMIC AGENTS; IMMUNOGLOBULIN FC FRAGMENTS; INSULIN GLARGINE; MALE; METFORMIN; MIDDLE AGED; RECOMBINANT FUSION PROTEINS; SULFONYLUREA COMPOUNDS; TREATMENT OUTCOME; WEIGHT LOSS;

EID: 84962338740     PISSN: 01495992     EISSN: 19355548     Source Type: Journal    
DOI: 10.2337/dc14-1625     Document Type: Article

References (30)

1. DeFronzo RA. Pathogenesis of type 2 diabetes mellitus. Med Clin North Am 2004;88:787-835.
2. Inzucchi SE, Bergenstal RM, Buse JB, et al. Management of hyperglycemia in type 2 diabetes, 2015: A patient-centered approach: update to a position statement of the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). Diabetes Care 2015;38:140-149.
3. Zinman B, Philis-Tsimikas A, Cariou B, et al.; NN1250-3579 (BEGIN Once Long) Trial Investigators. Insulin degludec versus insulin glargine in insulin-naive patients with type 2 diabetes: A 1-year, randomized, treat-to-target trial (BEGIN Once Long). Diabetes Care 2012;35: 2464-2471.
4. Riddle MC, Rosenstock J, Gerich J; Insulin Glargine 4002 Study Investigators. The treatto-target trial: Randomized addition of glargine or human NPH insulin to oral therapy of type 2 diabetic patients. Diabetes Care 2003;26:3080-3086.
5. Yki-Järvinen H, Kauppinen-Mäkelin R, Tiikkainen M, et al. Insulin glargine or NPH combined with metformin in type 2 diabetes: The LANMET study. Diabetologia 2006;49:442-451.
6. Diamant M, Van Gaal L, Stranks S, et al. Once weekly exenatide compared with insulin glargine titrated to target in patients with type 2 diabetes (DURATION-3): An open-label randomised trial. Lancet 2010;375:2234-2243.
7. Heine RJ, Van Gaal LF, Johns D, Mihm MJ, Widel MH, Brodows RG; GWAA Study Group. Exenatide versus insulin glargine in patients with suboptimally controlled type 2 diabetes: A randomized trial. Ann Intern Med 2005;143: 559-569.
8. Pratley RE, Stewart M, Cirkel D, Ye J, Perry C, Carr MC. HARMONY 4: 52-week efficacy of albiglutide vs insulin glargine in patients with type 2 diabetes mellitus. Presented at the 73rd Scientific Sessions of the American Diabetes Association Scientific Session, 21-25 June 2013, Chicago, IL.
9. Nauck M, Horton E, Andjelkovic M, et al.; T-emerge 5 Study Group. Taspoglutide, a onceweekly glucagon-like peptide 1 analogue, vs. insulin glargine titrated to target in patients with Type 2 diabetes: An open-label randomized trial. Diabet Med 2013;30:109-113.
10. Russell-Jones D, Vaag A, Schmitz O, et al.; Liraglutide Effect and Action in Diabetes 5 (LEAD-5) met+SU Study Group. 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: 2046-2055.
11. Glaesner W, Vick AM, Millican R, et al. Engineering and characterization of the long-acting glucagon-like peptide-1 analogue LY2189265, an Fc fusion protein. Diabetes Metab Res Rev 2010;26:287-296.
12. Trulicity [package insert]. Indianapolis, IN, Eli Lilly & Co, 2014.
13. Barrington P, Chien JY, Tibaldi F, Showalter HD, Schneck K, Ellis B. LY2189265, a long-acting glucagon-like peptide-1 analogue, showed a dose-dependent effect on insulin secretion in healthy subjects. Diabetes Obes Metab 2011; 13:434-438.
14. de la Pena A, Loghin C, Cui X, et al. Pharmacokinetics of once weekly dulaglutide in patients with type 2 diabetes mellitus. Presented at the 74th Scientific Session of the American Diabetes Association Scientific Session, June 13-17, 2014, San Francisco, CA.
15. Wysham C, Blevins T, Arakaki R, et al. 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: 2159-2167.
16. 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.
17. Umpierrez G, Tofé Povedano S, Ṕerez 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. Dungan KM, Povedano ST, Forst T, et al. Once-weekly dulaglutide versus once-daily liraglutide in metformin-treated patients with type 2 diabetes (AWARD-6): A randomised, openlabel, phase 3, non-inferiority trial. Lancet 2014;384:1349-1357.
19. World Medical Association Declaration of Helsinki. World Medical Association Declaration of Helsinki. Recommendations guiding physicians in biomedical research involving human subjects. JAMA 1997;277:925-926
20. Lantus [package insert]. Bridgewater, NJ, Sanofi U.S. LLC, 2013.
21. Kennedy L, HermanWH, Strange P, Harris A; GOAL A1C Team. Impact of active versus usual algorithmic titration of basal insulin and pointof-care versus laboratory measurement of HbA1c on glycemic control in patients with type 2 diabetes: The Glycemic Optimization with Algorithms and Labs at Point of Care (GOAL A1C) trial. Diabetes Care 2006;29:1-8.
22. Workgroup on Hypoglycemia, American Diabetes Association. Defining and reporting hypoglycemia in diabetes: A report from the American Diabetes AssociationWorkgroup on Hypoglycemia. Diabetes Care 2005;28:1245-1249.
23. Dmitrienko A, Tamhane AC, Wiens BL. General multistage gatekeeping procedures. Biom J 2008;50:667-677.
24. Westfall PH, Young SS. Resampling-Based Multiple Testing: Examples and Methods for P-Value Adjustment. New York, John Wiley & Sons, 1993.
25. 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;35:683-689.
26. Steinberg W, DeVries JH, Wadden TA, Jensen CB, Svendsen CB, Rosenstock J. Longitudinal monitoring of lipase and amylase in adults with type 2 diabetes and obesity: Evidence from two phase 3 randomized clinical trials with the once-daily GLP-1 analog liraglutide. Gastroenterology 2011;142(Suppl. 1): S850-S851.
27. Blevins T, Pullman J, Malloy J, et al. DURATION-5: Exenatide once weekly resulted in greater improvements in glycemic control compared with exenatide twice daily in patients with type 2 diabetes. J Clin Endocrinol Metab 2011;96:1301-1310.
28. DeVries JH, Bain SC, Rodbard HW, et al.; Liraglutide-Detemir Study Group. Sequential intensification of metformin treatment in type 2 diabetes with liraglutide followed by randomized addition of basal insulin prompted by A1C targets. Diabetes Care 2012;35:1446-1454.
29. Ferdinand KC, White WB, Calhoun DA, et al. 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. Pratley RE, Nauck M, Bailey T, et al.; 1860-LIRA-DPP-4 Study Group. Liraglutide versus sitagliptin for patients with type 2 diabetes who did not have adequate glycaemic control with metformin: A 26-week, randomised, parallelgroup, open-label trial. Lancet 2010;375:1447-1456.