메뉴 건너뛰기




Volumn 37, Issue 8, 2014, Pages 2149-2158

Efficacy and safety of dulaglutide versus sitagliptin after 52 weeks in type 2 diabetes in a randomized controlled trial (AWARD-5)

Author keywords

[No Author keywords available]

Indexed keywords

DULAGLUTIDE; GLUCOSE; HEMOGLOBIN A1C; INSULIN; METFORMIN; PLACEBO; SITAGLIPTIN; ANTIDIABETIC AGENT; GLUCAGON LIKE PEPTIDE; GLUCAGON LIKE PEPTIDE 1; GLUCOSE BLOOD LEVEL; GLYCOSYLATED HEMOGLOBIN; HYBRID PROTEIN; IMMUNOGLOBULIN FC FRAGMENT; PYRAZINE DERIVATIVE; TRIAZOLE DERIVATIVE;

EID: 84904992244     PISSN: 01495992     EISSN: 19355548     Source Type: Journal    
DOI: 10.2337/dc13-2761     Document Type: Article
Times cited : (244)

References (39)
  • 1
    • 84866268783 scopus 로고    scopus 로고
    • Management of hyperglycemia in type 2 diabetes: A patient-centered approach: Position statement of the American diabetes association (ADA) and the european association for the study of diabetes (EASD)
    • American Diabetes Association (ADA); European Association for the Study of Diabetes (EASD)
    • Inzucchi SE, Bergenstal RM, Buse J.B., et al; American Diabetes Association (ADA); European Association for the Study of Diabetes (EASD). Management of hyperglycemia in type 2 diabetes: a patient-centered approach: position statement of the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). Diabetes Care 2012; 35: 1364-1379
    • (2012) Diabetes Care , vol.35 , pp. 1364-1379
    • Inzucchi, S.E.1    Bergenstal, R.M.2    Buse, J.B.3
  • 2
    • 35748957503 scopus 로고    scopus 로고
    • The physiology of glucagon-like peptide 1
    • Holst JJ. The physiology of glucagon-like peptide 1. Physiol Rev 2007; 87: 1409-1439
    • (2007) Physiol Rev , vol.87 , pp. 1409-1439
    • Holst, J.J.1
  • 3
    • 0023104829 scopus 로고
    • Truncated glucagon-like peptide I, an insulin-releasing hormone from the distal gut
    • Holst JJ, Orskov C, Nielsen O.V., Schwartz TW. Truncated glucagon-like peptide I, an insulin-releasing hormone from the distal gut. FEBS Lett 1987; 211: 169-174
    • (1987) FEBS Lett , vol.211 , pp. 169-174
    • Holst, J.J.1    Orskov, C.2    Nielsen, O.V.3    Schwartz, T.W.4
  • 4
    • 0023638829 scopus 로고
    • Glucagon-like peptide-17-36: Aphysiological incretin in man
    • Kreymann B, Williams G, Ghatei M.A., Bloom SR. Glucagon-like peptide-17-36: aphysiological incretin in man. Lancet 1987; 2: 1300-1304
    • (1987) Lancet , vol.2 , pp. 1300-1304
    • Kreymann, B.1    Williams, G.2    Ghatei, M.A.3    Bloom, S.R.4
  • 5
    • 77955573674 scopus 로고    scopus 로고
    • Efficacy and safety of exenatide once weekly versus sitagliptin or pioglitazone as an adjunct to metformin for treatment of type 2 diabetes (DURATION-2): A randomised trial
    • DURATION-2 Study Group
    • Bergenstal RM, Wysham C, Macconell L., et al; DURATION-2 Study Group. Efficacy and safety of exenatide once weekly versus sitagliptin or pioglitazone as an adjunct to metformin for treatment of type 2 diabetes (DURATION-2): a randomised trial. Lancet 2010; 376: 431-439
    • (2010) Lancet , vol.376 , pp. 431-439
    • Bergenstal, R.M.1    Wysham, C.2    Macconell, L.3
  • 6
    • 77952309372 scopus 로고    scopus 로고
    • Liraglutide versus sita-gliptin for patients with type 2 diabetes who did not have adequate glycaemic control with metformin: A 26-week, randomised, parallel-group, open-label trial
    • 1860-LIRA-DPP-4 Study Group
    • Pratley RE, Nauck M, Bailey T., et al; 1860-LIRA-DPP-4 Study Group. Liraglutide versus sita-gliptin for patients with type 2 diabetes who did not have adequate glycaemic control with metformin: a 26-week, randomised, parallel-group, open-label trial. Lancet 2010; 375: 1447-1456
    • (2010) Lancet , vol.375 , pp. 1447-1456
    • Pratley, R.E.1    Nauck, M.2    Bailey, T.3
  • 7
    • 79953032228 scopus 로고    scopus 로고
    • LY2189265, a long-acting glucagon-like peptide-1 analogue, showed a dose-dependent effect on insulin secretion in healthy subjects
    • Barrington P, Chien JY, Tibaldi F, Showalter H.D., 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
    • (2011) Diabetes Obes Metab , vol.13 , pp. 434-438
    • Barrington, P.1    Chien, J.Y.2    Tibaldi, F.3    Showalter, H.D.4    Schneck, K.5    Ellis, B.6
  • 8
    • 77952756104 scopus 로고    scopus 로고
    • Engineering and characterization of the long-acting glucagon-like peptide-1 analogue LY2189265, an fc fusion protein
    • 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
    • (2010) Diabetes Metab Res Rev , vol.26 , pp. 287-296
    • Glaesner, W.1    Vick, A.M.2    Millican, R.3
  • 9
    • 84905029140 scopus 로고    scopus 로고
    • Data onfile, Eli Lilly and Companyand/or one of its subsidiaries
    • Data onfile, Eli Lilly and Companyand/or one of its subsidiaries
  • 10
    • 34248223285 scopus 로고    scopus 로고
    • Biology of incretins: GLP-1 and GIP
    • Baggio LL, Drucker DJ Biology of incretins: GLP-1 and GIP. Gastroenterology 2007; 132: 2131-2157
    • (2007) Gastroenterology , vol.132 , pp. 2131-2157
    • Baggio, L.L.1    Drucker, D.J.2
  • 11
    • 84866435806 scopus 로고    scopus 로고
    • Monotherapy with the once-weekly GLP-1 analogue dulaglutide for 12 weeks in patients with type 2 diabetes: Dose-dependent effects on glycaemic control in a randomized, double-blind, placebocontrolled study
    • Grunberger G, Chang A, Garcia Soria G, Botros FT, Bsharat R, Milicevic Z. Monotherapy with the once-weekly GLP-1 analogue dulaglutide for 12 weeks in patients with Type 2 diabetes: dose-dependent effects on glycaemic control in a randomized, double-blind, placebocontrolled study. Diabet Med 2012; 29: 1260-1267
    • (2012) Diabet Med , vol.29 , pp. 1260-1267
    • Grunberger, G.1    Chang, A.2    Garcia Soria, G.3    Botros, F.T.4    Bsharat, R.5    Milicevic, Z.6
  • 12
    • 79953035319 scopus 로고    scopus 로고
    • The effects of LY2189265, a long-acting glucagon-like peptide-1 analogue, in a randomized, placebo-controlled, double-blind study of overweight/obese patients with type 2 diabetes: The EGO study
    • 3rdEGO Study Group
    • Umpierrez GE, Blevins T, Rosenstock J., Cheng C, Anderson JH, Bastyr EJ 3rdEGO Study Group. The effects of LY2189265, a long-acting glucagon-like peptide-1 analogue, in a randomized, placebo-controlled, double-blind study of overweight/obese patients with type 2 diabetes: the EGO study. Diabetes Obes Metab 2011; 13: 418-425
    • (2011) Diabetes Obes Metab , vol.13 , pp. 418-425
    • Umpierrez, G.E.1    Blevins, T.2    Rosenstock, J.3    Cheng, C.4    Anderson, J.H.5    Bastyr, E.J.6
  • 13
    • 84882997236 scopus 로고    scopus 로고
    • An adaptive, dose-finding, seamless phase 2/3 study of a long-acting glucagon-like peptide-1 analog (dulaglutide): Trial design and baseline characteristics
    • Geiger MJ, Skrivanek Z, Gaydos B., Chien J, Berry S, Berry D. An adaptive, dose-finding, seamless phase 2/3 study of a long-acting glucagon-like peptide-1 analog (dulaglutide): trial design and baseline characteristics. J Diabetes Sci Tech 2012; 6: 1319-1327
    • (2012) J Diabetes Sci Tech , vol.6 , pp. 1319-1327
    • Geiger, M.J.1    Skrivanek, Z.2    Gaydos, B.3    Chien, J.4    Berry, S.5    Berry, D.6
  • 14
    • 84882961810 scopus 로고    scopus 로고
    • Application of adaptive design methodology in development of a long-acting glucagon-like peptide-1 analog (dulaglutide): Statistical design and simulations
    • Skrivanek Z, Berry S, Berry D., et al. Application of adaptive design methodology in development of a long-acting glucagon-like peptide-1 analog (dulaglutide): statistical design and simulations. J Diabetes Sci Tech 2012; 6: 1305-1318
    • (2012) J Diabetes Sci Tech , vol.6 , pp. 1305-1318
    • Skrivanek, Z.1    Berry, S.2    Berry, D.3
  • 15
    • 84883027307 scopus 로고    scopus 로고
    • Operational challenges and solutions with implementation of an adaptive seamless phase 2/3 study
    • Spencer K, Colvin K, Braunecker B., et al. Operational challenges and solutions with implementation of an adaptive seamless phase 2/3 study. J Diabetes Sci Tech 2012; 6: 1296-1304
    • (2012) J Diabetes Sci Tech , vol.6 , pp. 1296-1304
    • Spencer, K.1    Colvin, K.2    Braunecker, B.3
  • 16
    • 0031578033 scopus 로고    scopus 로고
    • Recommendations guiding physicians in biomedical research involving human subjects
    • World Medical Association. World Medical Association declaration of Helsinki
    • World Medical Association. World Medical Association declaration of Helsinki. Recommendations guiding physicians in biomedical research involving human subjects. JAMA 1997; 277: 925-926
    • (1997) JAMA , vol.277 , pp. 925-926
  • 18
    • 84984562369 scopus 로고    scopus 로고
    • Dose finding results in an adaptive trial of dulaglutide combined with metformin in type 2 diabetes (AWARD-5)
    • Skrivanek Z, Chien JY, Gaydos B, Heathman M., Geiger MJ, Milisevic Z. Dose finding results in an adaptive trial of dulaglutide combined with metformin in type 2 diabetes (AWARD-5). Diabetologia 2013; 56(Suppl. 1): S402
    • (2013) Diabetologia , vol.56 , Issue.SUPPL. 1
    • Skrivanek, Z.1    Chien, J.Y.2    Gaydos, B.3    Heathman, M.4    Geiger, M.J.5    Milisevic, Z.6
  • 20
    • 18144388647 scopus 로고    scopus 로고
    • Defining and reporting hypoglycemia in diabetes: A report from the American diabetes association workgroup on hypoglycemia
    • Workgroup on Hypoglycemia, American Diabetes Association
    • Workgroup on Hypoglycemia, American Diabetes Association. Defining and reporting hypoglycemia in diabetes: a report from the American Diabetes Association Workgroup on Hypoglycemia. Diabetes Care 2005; 28: 1245-1249
    • (2005) Diabetes Care , vol.28 , pp. 1245-1249
  • 21
    • 54549114505 scopus 로고    scopus 로고
    • General multistage gatekeeping procedures
    • Dmitrienko A, Tamhane AC, Wiens BL General multistage gatekeeping procedures. Biom J 2008; 50: 667-677
    • (2008) Biom J , vol.50 , pp. 667-677
    • Dmitrienko, A.1    Tamhane, A.C.2    Wiens, B.L.3
  • 22
    • 0034641568 scopus 로고    scopus 로고
    • Association of glycaemia with macrovascular and microvascular complications of type 2 diabetes (UKPDS 35): Prospective observational study
    • Stratton IM, Adler AI, Neil H.A., et al. Association of glycaemia with macrovascular and microvascular complications of type 2 diabetes (UKPDS 35): prospective observational study. BMJ 2000; 321: 405-412
    • (2000) BMJ , vol.321 , pp. 405-412
    • Stratton, I.M.1    Adler, A.I.2    Neil, H.A.3
  • 23
    • 67650066860 scopus 로고    scopus 로고
    • Efficacy and safety of the human glucagon-like peptide-1 analog liraglutide in combination with metformin and thiazolidinedione in patients with type 2 diabetes (LEAD-4 met+TZD)
    • LEAD-4 Study Investigators
    • Zinman B, Gerich J, Buse J.B., et al; LEAD-4 Study Investigators. Efficacy and safety of the human glucagon-like peptide-1 analog liraglutide in combination with metformin and thiazolidinedione in patients with type 2 diabetes (LEAD-4 Met+TZD). Diabetes Care 2009; 32: 1224-1230
    • (2009) Diabetes Care , vol.32 , pp. 1224-1230
    • Zinman, B.1    Gerich, J.2    Buse, J.B.3
  • 24
    • 62449169287 scopus 로고    scopus 로고
    • Efficacy and safety comparison of liraglutide, glimepiride, and placebo, all in combination with metformin, in type 2 diabetes: The LEAD (liraglutide effect and action in diabetes)-2 study
    • LEAD-2 Study Group
    • Nauck M, Frid A, Hermansen K., et al; LEAD-2 Study Group. Efficacy and safety comparison of liraglutide, glimepiride, and placebo, all in combination with metformin, in type 2 diabetes: the LEAD (liraglutide effect and action in diabetes)-2 study. Diabetes Care 2009; 32: 84-90
    • (2009) Diabetes Care , vol.32 , pp. 84-90
    • Nauck, M.1    Frid, A.2    Hermansen, K.3
  • 25
    • 59449101432 scopus 로고    scopus 로고
    • Liraglutide versus glime-piride monotherapy for type 2 diabetes (LEAD-3 mono): A randomised, 52-week, phase III, double-blind, parallel-treatment trial
    • LEAD-3 (Mono) Study Group
    • Garber A, Henry R, Ratner R., et al; LEAD-3 (Mono) Study Group. Liraglutide versus glime-piride monotherapy for type 2 diabetes (LEAD-3 Mono): a randomised, 52-week, phase III, double-blind, parallel-treatment trial. Lancet 2009; 373: 473-481
    • (2009) Lancet , vol.373 , pp. 473-481
    • Garber, A.1    Henry, R.2    Ratner, R.3
  • 26
    • 70350140201 scopus 로고    scopus 로고
    • Baseline differences in A1C explain apparent differences in efficacy of sitagliptin, rosiglitazone and pioglitazone
    • Chapell R, Gould AL, Alexander CM Baseline differences in A1C explain apparent differences in efficacy of sitagliptin, rosiglitazone and pioglitazone. Diabetes Obes Metab 2009; 11: 1009-1016
    • (2009) Diabetes Obes Metab , vol.11 , pp. 1009-1016
    • Chapell, R.1    Gould, A.L.2    Alexander, C.M.3
  • 27
    • 84866650686 scopus 로고    scopus 로고
    • Efficacy and safety of switching from the DPP-4 inhibitor sitagliptin to the human GLP-1 analog liraglutide after 52 weeks in metformin-treated patients with type 2 diabetes: A randomized, open-label trial
    • 1860-LIRA-DPP-4 Study Group
    • Pratley RE, Nauck MA, Bailey T, et al; 1860-LIRA-DPP-4 Study Group. Efficacy and safety of switching from the DPP-4 inhibitor sitagliptin to the human GLP-1 analog liraglutide after 52 weeks in metformin-treated patients with type 2 diabetes: a randomized, open-label trial. Diabetes Care 2012; 35: 1986-1993
    • (2012) Diabetes Care , vol.35 , pp. 1986-1993
    • Pratley, R.E.1    Nauck, M.A.2    Bailey, T.3
  • 28
    • 55549136417 scopus 로고    scopus 로고
    • Effects of exenatide versus sitagliptin on postprandial glucose, insulin and glucagon secretion, gastric emptying, and caloric intake: A randomized, cross-over study
    • DeFronzo RA, Okerson T, Viswanathan P., Guan X, Holcombe JH, MacConell L. Effects of exenatide versus sitagliptin on postprandial glucose, insulin and glucagon secretion, gastric emptying, and caloric intake: a randomized, cross-over study. Curr Med Res Opin 2008; 24: 2943-2952
    • (2008) Curr Med Res Opin , vol.24 , pp. 2943-2952
    • DeFronzo, R.A.1    Okerson, T.2    Viswanathan, P.3    Guan, X.4    Holcombe, J.H.5    MacConell, L.6
  • 29
    • 33845472504 scopus 로고    scopus 로고
    • Effect of the dipeptidyl peptidase-4 inhibitor sitagliptin as monotherapy on glycemic control in patients with type 2 diabetes
    • Sitagliptin Study 021 Group
    • Aschner P, Kipnes MS, Lunceford J.K., Sanchez M., Mickel C, Williams-Herman DE; Sitagliptin Study 021 Group. Effect of the dipeptidyl peptidase-4 inhibitor sitagliptin as monotherapy on glycemic control in patients with type 2 diabetes. Diabetes Care 2006; 29: 2632-2637
    • (2006) Diabetes Care , vol.29 , pp. 2632-2637
    • Aschner, P.1    Kipnes, M.S.2    Lunceford, J.K.3    Sanchez, M.4    Mickel, C.5    Williams-Herman, D.E.6
  • 30
    • 2342599057 scopus 로고    scopus 로고
    • One week's treatment with the long-acting glucagon-like peptide 1 derivative liraglutide (NN2211) markedly improves 24-h glycemia and alpha- and beta-cell function and reduces endogenous glucose release in patients with type 2 diabetes
    • Degn KB, Juhl CB, Sturis J, et al One week's treatment with the long-acting glucagon-like peptide 1 derivative liraglutide (NN2211) markedly improves 24-h glycemia and alpha- and beta-cell function and reduces endogenous glucose release in patients with type 2 diabetes. Diabetes 2004; 53: 1187-1194
    • (2004) Diabetes , vol.53 , pp. 1187-1194
    • Degn, K.B.1    Juhl, C.B.2    Sturis, J.3
  • 31
    • 28844482322 scopus 로고    scopus 로고
    • Pharmacokinetics and pharmacodynamics of sitagliptin, an inhibitor of dipeptidyl peptidase IV, in healthy subjects: Results from two randomized, double-blind, placebo-controlled studies with single oral doses
    • Herman GA, Stevens C, Van Dyck K, et al. Pharmacokinetics and pharmacodynamics of sitagliptin, an inhibitor of dipeptidyl peptidase IV, in healthy subjects: results from two randomized, double-blind, placebo-controlled studies with single oral doses. Clin Pharmacol Ther 2005; 78: 675-688
    • (2005) Clin Pharmacol Ther , vol.78 , pp. 675-688
    • Herman, G.A.1    Stevens, C.2    Van Dyck, K.3
  • 32
    • 84883809988 scopus 로고    scopus 로고
    • Determinants of weight gain in the action to control cardiovascular risk in diabetes trial
    • ACCORD Study Group
    • Fonseca V, McDuffie R, Calles J., et al.; ACCORD Study Group. Determinants of weight gain in the Action to Control Cardiovascular Risk in Diabetes Trial. Diabetes Care 2013; 36: 2162-2168
    • (2013) Diabetes Care , vol.36 , pp. 2162-2168
    • Fonseca, V.1    McDuffie, R.2    Calles, J.3
  • 33
    • 0032005005 scopus 로고    scopus 로고
    • Glucagonlike peptide 1 promotes satiety and suppresses energy intake in humans
    • Flint A, Raben A, Astrup A., Holst JJ. Glucagonlike peptide 1 promotes satiety and suppresses energy intake in humans. J Clin Invest 1998; 101: 515-520
    • (1998) J Clin Invest , vol.101 , pp. 515-520
    • Flint, A.1    Raben, A.2    Astrup, A.3    Holst, J.J.4
  • 34
    • 0033304603 scopus 로고    scopus 로고
    • The glucagon-like peptides
    • Kieffer TJ, Habener JF The glucagon-like peptides. Endocr Rev 1999; 20: 876-913
    • (1999) Endocr Rev , vol.20 , pp. 876-913
    • Kieffer, T.J.1    Habener, J.F.2
  • 35
    • 33846006173 scopus 로고    scopus 로고
    • The incretin system: Glucagon-like peptide-1 receptor agonists and dipeptidyl peptidase-4 inhibitors in type 2 diabetes
    • Drucker DJ, Nauck MA The incretin system: glucagon-like peptide-1 receptor agonists and dipeptidyl peptidase-4 inhibitors in type 2 diabetes. Lancet 2006; 368: 1696-1705
    • (2006) Lancet , vol.368 , pp. 1696-1705
    • Drucker, D.J.1    Nauck, M.A.2
  • 36
    • 84872084453 scopus 로고    scopus 로고
    • Exenatide once weekly versus liraglutide once daily in patients with type 2 diabetes (DURATION-6): A randomised, open-label study
    • Buse JB, Nauck M, Forst T., et al. 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
    • (2013) Lancet , vol.381 , pp. 117-124
    • Buse, J.B.1    Nauck, M.2    Forst, T.3
  • 37
    • 79955661908 scopus 로고    scopus 로고
    • DURATION-5: Exenatide once weekly resulted in greater improvements in glycemic control compared with exenatide twice daily in patients with type 2 diabetes
    • 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
    • (2011) J Clin Endocrinol Metab , vol.96 , pp. 1301-1310
    • Blevins, T.1    Pullman, J.2    Malloy, J.3
  • 38
    • 77955833026 scopus 로고    scopus 로고
    • The safety and tolerability of GLP-1 receptor agonists in the treatment of type-2 diabetes
    • Russell-Jones D. The safety and tolerability of GLP-1 receptor agonists in the treatment of type-2 diabetes. Int J Clin Pract 2010; 64: 1402-1414
    • (2010) Int J Clin Pract , vol.64 , pp. 1402-1414
    • Russell-Jones, D.1
  • 39
    • 32944459736 scopus 로고    scopus 로고
    • Factors influencing the immunogenicity of therapeutic proteins
    • Schellekens H. Factors influencing the immunogenicity of therapeutic proteins. Nephrol Dial Transplant 2005; 20(Suppl. 6): vi3-vi9
    • (2005) Nephrol Dial Transplant , vol.20 , Issue.SUPPL. 6
    • Schellekens, H.1


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.