Dulaglutide, a long-acting GLP-1 analog fused with an Fc antibody fragment for the potential treatment of type 2 Diabetes

Current Opinion in Molecular Therapeutics

Volumn 12, Issue 6, 2010, Pages 790-797

  Jimenez Solem, Espen ^a   Rasmussen, Mette H ^a   Christensen, Mikkel ^a   Knop, Filip K ^a  

^a UNIVERSITY OF COPENHAGEN   (Denmark)

Author keywords

[No Author keywords available]

Indexed keywords

C PEPTIDE; DULAGLUTIDE; EXENDIN 4; FC RECEPTOR; FIBROBLAST GROWTH FACTOR 21; GLIMEPIRIDE; GLUCAGON LIKE PEPTIDE 1; GLUCOSE; HEMOGLOBIN A1C; INSULIN; INSULIN GLARGINE; INSULIN LISPRO; LY 2189265; METFORMIN; PARACETAMOL; PLACEBO; SITAGLIPTIN; UNCLASSIFIED DRUG;

ABDOMINAL DISTENSION; ADD ON THERAPY; ARTICLE; BODY WEIGHT; DIABETIC PATIENT; DIARRHEA; DIASTOLIC BLOOD PRESSURE; DOSE RESPONSE; DRUG CONTRAINDICATION; DRUG DOSE COMPARISON; DRUG DOSE ESCALATION; DRUG EFFICACY; DRUG HALF LIFE; DRUG METABOLISM; DRUG SCREENING; DYSPEPSIA; GASTROINTESTINAL DISEASE; GLUCOSE BLOOD LEVEL; HEADACHE; HEART RATE; HUMAN; HYPOGLYCEMIA; IN VITRO STUDY; IN VIVO STUDY; INJECTION SITE REACTION; INSULIN BLOOD LEVEL; INSULIN LIKE ACTIVITY; INSULIN RELEASE; MULTICENTER STUDY (TOPIC); NAUSEA AND VOMITING; NON INSULIN DEPENDENT DIABETES MELLITUS; NONHUMAN; OBESITY; PHASE 1 CLINICAL TRIAL (TOPIC); PHASE 2 CLINICAL TRIAL (TOPIC); PHASE 3 CLINICAL TRIAL (TOPIC); PROTEIN BLOOD LEVEL; RANDOMIZED CONTROLLED TRIAL (TOPIC); SIDE EFFECT; SINGLE DRUG DOSE; STOMACH EMPTYING; STRUCTURE ACTIVITY RELATION; SYSTOLIC BLOOD PRESSURE;

BLOOD GLUCOSE; C-PEPTIDE; CLINICAL TRIALS AS TOPIC; DIABETES MELLITUS, TYPE 2; GASTROINTESTINAL DISEASES; GLUCAGON-LIKE PEPTIDE 1; HEMOGLOBIN A, GLYCOSYLATED; HUMANS; HYPOGLYCEMIC AGENTS; IMMUNOGLOBULIN FC FRAGMENTS; INSULIN; RECOMBINANT FUSION PROTEINS; TREATMENT OUTCOME;

EQUUS ASINUS;

EID: 79952932916     PISSN: 14648431     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (63)

1. Glucagon-like peptide-1 and exendin-4 stimulate β-cell neoGenesis in streptozotocin-treated newborn rats Resulting in persistently improved glucose homeostasis at adult age. Tourrel C, Bailbe D, Meile MJ, Kergoat M, Portha B Diabetes 2001 50 7 1562-1570 (Pubitemid 33639596) (Pubitemid 33639596)
2. Glucagon-like peptide-1 promotes islet cell growth and inhibits apoptosis in Zucker diabetic rats. Farilla L, Hui H, Bertolotto C, Kang E, Bulotta A, Di Mariou, Perfetti R Endocrinology 2002 143 11 4397-4408 (Pubitemid 35239574) (Pubitemid 35239574)
3. Effect of 6-week course of glucagon-like peptide 1 on glycaemic control, insulin sensitivity, and β-cell function in type 2 Diabetes: A parallel-group study. Zander M, Madsbad S, Lysgaard MJ, Holst JJ Lancet 2002 359 9309 824-830 (Pubitemid 34233752) (Pubitemid 34233752)
4. Effects of glucagon-like peptide-1 in patients with acute myocardial infarction and left ventricular dysfunction after successful reperfusion. Nikolaidis LA, Mankad S, Sokos GG, Miske G, Shah A, Elahi D, Shannon RP Circulation 2004 109 8 962-965 (Pubitemid 38282847) (Pubitemid 38282847)
5. Normalization of fasting hyperglycaemia by exogenous glucagon-like peptide 1 (7-36 amide) in type 2 (non-insulin-dependent) diabetic patients. Nauck MA, Kleine N, Orskov C, Holst JJ, Willms B, Creutzfeldt W Diabetologia 1993 36 8 741-744 (Pubitemid 23218642) (Pubitemid 23218642)
6. Biology of incretins: GLP-1 and GIP. Baggio LL, Drucker DJ GASTROENTEROLOGY 2007 132 6 2131-2157 (Pubitemid 46711096) (Pubitemid 46711096)
7. The physiology of glucagon-like peptide 1. Holst JJ PHYSIOL Rev 2007 87 4 1409-1439 (Pubitemid 350041474) (Pubitemid 350041474)
8. Incretins, insulin secretion and type 2 Diabetes mellitus. Vilsboll T, Holst JJ Diabetologia 2004 47 3 357-366 (Pubitemid 38491230) (Pubitemid 38491230)
9. Global prevalence of Diabetes: Estimates for the year 2000 and projections for 2030. Wild S, Roglic G, Green A, Sicree R, King H Diabetes Care 2004 27 5 1047-1053 (Pubitemid 38579764) (Pubitemid 38579764)
10. Islet β cell failure in type 2 Diabetes. Prentki M, Nolan CJ J Clin Invest 2006 116 7 1802-1812 (Pubitemid 44033300) (Pubitemid 44033300)
11. PReserved incretin activity of glucagon-like peptide 1 [7-36 amide] but not of synthetic human gastric inhibitory polypeptide in patients with type-2 Diabetes mellitus. Nauck MA, Heimesaat MM, Orskov C, Holst JJ, Ebert R, Creutzfeldt W J Clin Invest 1993 91 1 301-307 (Pubitemid 23037285) (Pubitemid 23037285)
12. NCT00734474: A study of LY2189265 compared to sitagliptin in patients with type 2 Diabetes mellitus on metformin. Eli Lilly & Co CLINICALTRIALS.GOV 2008
13. Exenatide once weekly versus twice daily for the treatment of type 2 Diabetes: A randomised, open-label, non-inferiority study. Drucker DJ, Buse JB, Taylor K, Kendall DM, Trautmann M, Zhuang DL, Porter L Lancet 2008 372 9645 1240-1250
14. Lilly highlights transformation strategy for Wall Street, reviews robust pipeline and sets 2009 financial guidance. Eli Lilly & Co Press Release 2008 December 11
15. Efficacy and safety of incretin Therapy in type 2 Diabetes: Systematic review and meta-analysis. Amori RE, Lau J, Pittas AG JAMA-J AM Med Assoc 2007 298 2 194-206 (Pubitemid 47057766) (Pubitemid 47057766)
16. The relative contributions of insulin Resistance and β-cell dysfunction to the pathophysiology of type 2 Diabetes. Kahn SE Diabetologia 2003 46 1 3-19 (Pubitemid 36237741) (Pubitemid 36237741)
17. The role of impaired early insulin secretion in the pathoGenesis of type II Diabetes mellitus. Pratley RE, Weyer C Diabetologia 2001 44 8 929-945 (Pubitemid 32778125) (Pubitemid 32778125)
18. U.K. prospective Diabetes study 16. Overview of 6 years' Therapy of type II Diabetes: A progRessive disease. U.K. Prospective Diabetes Study Group. No authors listed Diabetes 1995 44 11 1249-1258
19. Systematic review: Comparative effectiveness and safety of oral medications for type 2 Diabetes mellitus. Bolen S, Feldman L, Vassy J, Wilson L, Yeh HC, Marinopoulos S, Wiley C, Selvin E, Wilson R, Bass EB, Brancati FL Ann Intern Med 2007 147 6 386-399 (Pubitemid 351664540) (Pubitemid 351664540)
20. The importance of β-cell management in type 2 Diabetes. Standl E Int J Clin PRACT SUPPL 2007 153 10-19 (Pubitemid 47000685)
21. Medical management of hyperglycemia in type 2 Diabetes: A consensus algorithm for the initiation and adjustment of Therapy: A consensus statement of the American Diabetes Association and the European Association for the Study of Diabetes. Nathan DM, Buse JB, Davidson MB, Ferrannini E, Holman RR, Sherwin R, Zinman B Diabetes Care 2009 32 1 193-203
22. Trends in A1C concentrations among U.S. adults with diagnosed Diabetes from 1999 to 2004. Ford ES, Li C, Little RR, Mokdad AH Diabetes Care 2008 31 1 102-104
23. Attitudes of primary care providers toward Diabetes: Barriers to guideline implementation. Larme AC, Pugh JA Diabetes Care 1998 21 9 1391-1396 (Pubitemid 28405187) (Pubitemid 28405187)
24. Insulin treatment and the problem of weight gain in type 2 Diabetes. Carver C Diabetes EDUCATOR 2006 32 6 910-917 (Pubitemid 44706818) (Pubitemid 44706818)
25. When oral agents fail: Practical barriers to starting insulin. Korytkowski M Int J ObesITY RELAT Metab DISORD 2002 26 Suppl 3 S18-S24 (Pubitemid 35034478) (Pubitemid 35034478)
26. Reduced incretin effect in type 2 (non-insulin-dependent) Diabetes. Nauck M, Stockmann F, Ebert R, Creutzfeldt W Diabetologia 1986 29 1 46-52 (Pubitemid 16162741) (Pubitemid 16162741)
27. International Union of Pharmacology. XXXV. The glucagon receptor family. Mayo KE, Miller LJ, Bataille D, Dalle S, Goke B, Thorens B, Drucker DJ Pharmacol Rev 2003 55 1 167-194 (Pubitemid 36268402) (Pubitemid 36268402)
28. Cardioprotective and vasodilatory actions of glucagonlike peptide 1 receptor are mediated through both glucagon-like peptide 1 receptor-dependent and-independent pathways. Ban K, Noyan-Ashraf MH, Hoefer J, Bolz SS, Drucker DJ, Husain M Circulation 2008 117 18 2340-2350 (Pubitemid 351653542) (Pubitemid 351653542)
29. Glucagon-like peptide-1 prevents β cell glucolipotoxicity. Buteau J, El-Assaad W, Rhodes CJ, Rosenberg L, Joly E, Prentki M Diabetologia 2004 47 5 806-815 (Pubitemid 38756992) (Pubitemid 38756992)
30. Glucagon-like peptide-1 relaxes rat conduit arteries via an endothelium-independent mechanism. Nystrom T, Gonon AT, Sjoholm A, Pernow J Regul Pept 2005 125 1-3 173-177 (Pubitemid 39593722) (Pubitemid 39593722)
31. Glucagon-like peptide-1: A potent regulator of food intake in humans. Gutzwiller JP, Goke B, Drewe J, Hildebrand P, Ketterer S, Handschin D, Winterhalder R, Conen D, Beglinger C Gut 1999 44 1 81-86 (Pubitemid 29143284) (Pubitemid 29143284)
32. Glucagon-like peptide 1 improves the ability of the β-cell to sense and Respond to glucose in subjects with impaired glucose tolerance. Byrne MM, Gliem K, Wank U, Arnold R, Katschinski M, Polonsky KS, Goke B Diabetes 1998 47 8 1259-1265 (Pubitemid 28357003) (Pubitemid 28357003)
33. Near normalisation of Blood glucose improves the potentiating effect of GLP-1 on glucose-induced insulin secretion in patients with type 2 Diabetes. Hojberg PV, Zander M, Vilsboll T, Knop FK, Krarup T, Volund A, Holst JJ, Madsbad S Diabetologia 2008 51 4 632-640
34. Reduced postprandial concentrations of intact biologically active glucagon-like peptide 1 in type 2 diabetic patients. Vilsboll T, Krarup T, Deacon CF, Madsbad S, Holst JJ Diabetes 2001 50 3 609-613 (Pubitemid 32195226) (Pubitemid 32195226)
35. Similar elimination rates of glucagon-like peptide-1 in Obese type 2 diabetic patients and healthy subjects. Vilsboll T, Agerso H, Krarup T, Holst JJ J Clin Endocrinol Metab 2003 88 1 220-224 (Pubitemid 36115169) (Pubitemid 36115169)
36. Incretin hormone mimetics and analogues in Diabetes Therapeutics. Green BD, Flatt PR BEST PRACT Res Clin Endocrinol Metab 2007 21 4 497-516 (Pubitemid 350177567) (Pubitemid 350177567)
37. Liraglutide versus glimepiride monoTherapy for type 2 Diabetes (LEAD-3 Mono): A randomised, 52-week, phase III, double-blind, parallel-treatment trial. Garber A, Henry R, Ratner R, Garcia-Hernandez PA, Rodriguez-Pattzi H, Olvera-Alvarez I, Hale PM, Zdravkovic M, Bode B Lancet 2009 373 9662 473-481
38. Immunogenicity of xenopeptide hormone Therapies. Schnabel CA, Fineberg SE, Kim DD Peptides 2006 27 7 1902-1910 (Pubitemid 43866282) (Pubitemid 43866282)
39. Exenatide reduces infarct size and improves cardiac function in a porcine model of ischemia and reperfusion injury. Timmers L, Henriques JP, de Kleijn DP, Devries JH, Kemperman H, Steendijk P, Verlaan CW, Kerver M, Piek JJ, Doevendans PA, Pasterkamp G et al J AM COLL CARDIOL 2009 53 6 501-510
40. New potential adjuncts to treatment of children with type 1 Diabetes mellitus. Raman VS, Heptulla RA Pediatr Res 2009 65 4 370-374
41. Resistance to insulin Therapy among patients and providers: Results of the cross-national Diabetes Attitudes, Wishes, and Needs (DAWN) study. Peyrot M, Rubin RR, Lauritzen T, Skovlund SE, Snoek FJ, Matthews DR, Landgraf R, Kleinebreil L Diabetes Care 2005 28 11 2673-2679 (Pubitemid 43951158) (Pubitemid 43951158)
42. Safety, tolerability, pharmacokinetics, and insulinotropic activity of single subcutaneous doses of LY2189265, a longacting glucagon-like peptide 1 (GLP-1) analog in healthy subjects. Barrington P, Chien JY, Tibaldi F, Showalter HDH, Schneck KB, Ellis B Diabetes 2009 58 Suppl 1 Abs 583-P
43. Titration effect of LY2189265 (GLP-1 analog) once weekly on Metabolic outcomes and GI events in uncontrolled type 2 Diabetes mellitus (T2DM): The EGO study. Umpierrez G, Blevins T, Rosenstock J, Cheng C, Bastyr E, Anderson J Diabetes 2009 58 Suppl 1A Abs LB-12
44. Intensive Blood glucose control and vascular outcomes in patients with type 2 Diabetes. Patel A, MacMahon S, Chalmers J, Neal B, Billot L, Woodward M, Marre M, Cooper M, Glasziou P, Grobbee D, Hamet P et al N Engl J Med 2008 358 24 2560-2572 (Pubitemid 351831357) (Pubitemid 351831357)
45. Novo Nordisk's Victoza receives FDA approval for adults with type 2 Diabetes. Novo Nordisk A/S Press Release 2010 January 25
46. Reductions in glycemia and weight with once weekly dosing of LY2189265, a long-acting glucagon-like peptide 1 (GLP-1) analog in patients with type 2 Diabetes mellitus. Barrington P, Hardy TA, Chien JY, Showalter HDH, Schneck KB, Cui S, Tibaldi F, Ellis B Diabetes 2009 58 Suppl 1 161-OR
47. Safety, tolerability, pharmacokinetics, and insulinotropic activity of single subcutaneous doses of LY2189265, a long-acting glucagon-like peptide 1 analogue in healthy subjects. Barrington P, Chien J, Tibaldi F, Showalter H, Schneck K, Ellis B Diabetologia 2009 52 Suppl 1 Abs 781
48. Surveillance of lipase and amylase levels in type 2 Diabetes patients assessed during a randomized clinical study: The EGO study experience. Bastyr EJ, Vinik A, Owyang C, Cheng C, Shu J, Hall NC Diabetologia 2009 52 Suppl 1 Abs 770
49. Reductions in glycaemia and weight with once-weekly dosing of LY2189265, a long-acting glucagon-like peptide 1 (GLP-1) analogue in patients with type 2 Diabetes mellitus. Hardy TA, Barrington P, Chien J, Showalter H, Schneck K, Cui S, Tibaldi F, Ellis B Diabetologia 2009 52 Suppl 1 Abs 731
50. The effect of LY2189265 (GLP-1 analogue) once weekly on HbA(1c) and β cell function in uncontrolled type 2 Diabetes mellitus: The EGO study analysis. Umpierrez G, Blevins T, Rosenstock J, Cheng C, Bastyr E, Anderson J Diabetologia 2009 52 Suppl 1 Abs 129
51. NCT01075282: A study in patients with type 2 Diabetes mellitus (AWARD-2). Eli Lilly & Co CLINICALTRIALS.GOV 2010
52. NCT01001104: A study of LY2189265 in Japanese patients with type 2 Diabetes. Eli Lilly & Co CLINICALTRIALS.GOV 2009
53. Engineering and characterization of the long-acting glucagon-like peptide-1 analogue LY2189265, an Fc fusion protein. Glaesner W, Vick AM, Millican R, Ellis B, Tschang S-H, Tian Y, Bokvist K, Brenner M, Koester A, Porksen N, Etgen G et al Diabetes-METAB Res Rev 2010 26 4 287-296
54. The impact of Hispanic ethnicity on the Response to LY2189265 (GLP-1 analog) treatment of uncontrolled type 2 Diabetes mellitus (T2DM) patients: An EGO study analysis. Bastyr EJ, Noriega J, Botros FT, Threlkeld R, Shu JF, Anderson JH, Glass LC Diabetes 2010 59 Suppl 1 Abs 589-P
55. LY2189265, a long-acting glucagon-like peptide 1 (GLP-1) analog, does not affect gastric emptying of acetaminophen after multiple dosing in healthy subjects. Chien JY, Cui S, Chaudhary A, Loghin C Diabetes 2010 59 Suppl 1 Abs 600-P
56. The impact of LY2189265 (GLP-1 analog) on glycemic control in Hispanic and non-Hispanic Caucasians with uncontrolled type 2 Diabetes: An EGO study analysis. Noriega J, Botros F, Threlkeld R, Shu J, Anderson J, Glass L, Bastyr E J Invest Med 2010 58 4 Abs 4
57. Treatment with LY2189265 (GLP-1 analogue) causes larger decreases in postprandial glucose excursion in Hispanics compared to non-Hispanic Caucasians with uncontrolled type 2 Diabetes: An EGO Study exploratory analysis. Bastyr EJ, Noriega J, Botros E, Shu J, Glass LC Diabetologia 2010 53 Suppl 1 Abs 845
58. NCT01126580: A study in patients with type 2 Diabetes mellitus (AWARD-3). Eli Lilly & Co CLINICALTRIALS.GOV 2010
59. Prevention of cardiovascular disease in persons with type 2 Diabetes mellitus: Current knowledge and rationale for the action to control cardiovascular risk in Diabetes (ACCORD) trial. Goff DC, Gerstein HC, Ginsberg HN, Cushman WC, Margolis KL, Byington RP, Buse JB, Genuth S, Probstfeld JL, Simons-Morton DG Am J Cardiol 2007 99 12A 4i-20i
60. Glucose control and vascular complications in veterans with type 2 Diabetes. Duckworth W, Abraira C, Moritz T, Reda D, Emanuele N, Reaven PD, Zieve FJ, Marks J, Davis SN, Hayward R, Warren SR et al N Engl J Med 2009 360 2 129-139
61. Endogenous glucagon-like peptide 1 controls endocrine pancreatic secretion and antro-pyloro-duodenal motility in humans. Schirra J, Nicolaus M, Roggel R, Katschinski M, Storr M, Woerle HJ, Goke B Gut 2006 55 2 243-251 (Pubitemid 43117285) (Pubitemid 43117285)
62. Once-weekly GLP-1 agonists: How do they differ from exenatide and liraglutide? Christensen M, Knop FK CURR Diab REP 2010 10 2 124-132
63. Tailoring natural effector functions. Antibody engineering beyond humanization. Brekke OH, Thommesen JE METHODS Mol Biol 2003 207 383-391