Clinical efficacy and safety of once-weekly glucagon-like peptide-1 agonists in development for treatment of type 2 diabetes mellitus in adults;Agonistas del Péptido-1 Similar a Glucagón en Estudio: Eficacia Clínica y Seguridad del Uso Una Vez en Semana de Los Agonistas del Peptido-1 Similar a Glucagón en Estudio Para

Annals of Pharmacotherapy

Volumn 46, Issue 1, 2012, Pages 68-78

  Tzefos, Maria ^a,b   Harris, Kira ^a   Brackett, Adriane ^a  

^a WINGATE UNIVERSITY   (United States)

^b Cabarrus Family Medicine   (United States)

Author keywords

Albiglutide; Exenatide LAR; Glucagon like peptide 1 agonist; Taspoglutide; Type 2 diabetes mellitus

Indexed keywords

ALBIGLUTIDE; CHOLESTEROL; DIPEPTIDYL PEPTIDASE IV; EXENDIN 4; GLUCAGON; GLUCOSE; HEMOGLOBIN A1C; INSULIN; INSULIN GLARGINE; LOW DENSITY LIPOPROTEIN CHOLESTEROL; METFORMIN; MICROSPHERE; ORAL ANTIDIABETIC AGENT; PIOGLITAZONE; PLACEBO; POLYMER; SITAGLIPTIN; SULFONYLUREA; TASPOGLUTIDE; TRIACYLGLYCEROL;

ABDOMINAL PAIN; ADD ON THERAPY; ADULT; ANTIBODY TITER; BACKACHE; BODY WEIGHT; CONTROLLED DRUG RELEASE; CONTROLLED RELEASE FORMULATION; CONTUSION; DIARRHEA; DIASTOLIC BLOOD PRESSURE; DIZZINESS; DOSAGE SCHEDULE COMPARISON; DRUG APPROVAL; DRUG BLOOD LEVEL; DRUG DOSAGE FORM COMPARISON; DRUG DOSE ESCALATION; DRUG DOSE TITRATION; DRUG EFFECT; DRUG EFFICACY; DRUG ERUPTION; DRUG HALF LIFE; DRUG MEGADOSE; DRUG SAFETY; DRUG SUBSTITUTION; DRUG TOLERABILITY; DRUG WITHDRAWAL; DYSPEPSIA; ECG ABNORMALITY; EDEMA; EDEMATOUS PANCREATITIS; FLATULENCE; FOOD AND DRUG ADMINISTRATION; GLUCAGON RELEASE; GLUCOSE BLOOD LEVEL; GLYCEMIC CONTROL; HEADACHE; HEART VENTRICLE EXTRASYSTOLE; HUMAN; HYPOGLYCEMIA; INJECTION SITE REACTION; INSULIN RELEASE; LABORATORY TEST; MEDLINE; MULTICENTER STUDY (TOPIC); NAUSEA; NAUSEA AND VOMITING; NON INSULIN DEPENDENT DIABETES MELLITUS; PANCREATITIS; PATIENT COMPLIANCE; PATIENT SATISFACTION; PHASE 2 CLINICAL TRIAL (TOPIC); PRIORITY JOURNAL; PROTEIN DEGRADATION; PUBLICATION; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL (TOPIC); REVIEW; RHINOPHARYNGITIS; SIDE EFFECT; STOMACH EMPTYING; SYSTEMATIC REVIEW; SYSTOLIC BLOOD PRESSURE; UPPER ABDOMINAL PAIN; UPPER RESPIRATORY TRACT INFECTION; VOMITING; WEIGHT REDUCTION;

ADULT; DELAYED-ACTION PREPARATIONS; DIABETES MELLITUS, TYPE 2; DRUG ADMINISTRATION SCHEDULE; GLUCAGON-LIKE PEPTIDE 1; HUMANS; HYPOGLYCEMIC AGENTS; PEPTIDES; RANDOMIZED CONTROLLED TRIALS AS TOPIC; TREATMENT OUTCOME; VENOMS;

EID: 84855680846     PISSN: 10600280     EISSN: None     Source Type: Journal    
DOI: 10.1345/aph.1Q379     Document Type: Review

References (46)

1. Holst JJ. The physiology of glucagon-like peptide 1. Physiol Rev 2007;87:1409-39. DOI 10.1152/physrev.00034.2006
2. Frias JP, Edelman SV. Incretins and their role in the management of diabetes. Curr Opin Endocrinol Diabetes Obes 2007;14:269-76. DOI 10.1097/MED.Ob013e32825ea2ba
3. Nauck MA, Baller B, Meier JJ. Gastric inhibitory polypeptide and glucagon-like peptide-1 in the pathogenesis of type 2 diabetes. Diabetes 2004;53:S190-6. DOI 10.2337/diabetes.53.suppl_3.S190
4. Kreymann B, Ghatei MA, Williams G, Bloom SR. Glucagon-like peptide-1 7-36: a physiological incretin in man. Lancet 1987;2:1300-4. DOI 10.1016/S0140-6736(87)91194-9
5. Nauck M, Stockmann F, Ebert R, Creutzfeldt W. Reduced incretin effect in type 2 (non-insulin-dependent) diabetes. Diabetologia 1986;29:46-52. DOI 10.1007/BF02427280
6. Nauck MA, Kleine N, Orskov C, Holst JJ, Willms B, Creutzfeldt W. Normalization of fasting hyperglycemia by exogenous glucagon-like peptide 1 (7-36 amide) in type 2 (non-insulin-dependent) diabetic patients. Diabetologia 1993;36:741-4. DOI 10.1007/BF00401145
7. Toft-Nielsen M, Madsbad S, Holst JJ. Continuous subcutaneous infusion of glucagon-like peptide 1 lowers plasma glucose and reduces appetite in type 2 diabetic patients. Diabetes Care 1999;22:1137-43. DOI 10.2337/diacare.22.7.1137
8. Holst JJ. Glucagon-like peptide-1: from extract to agent. The Claude Bernard Lecture, 2005. Diabetologia 2006;49:253-60. DOI 10.1007/s00125-005-0107-1
9. Christensen M, Knop FK. Once weekly GLP-1 agonists: how do they differ from exenatide and liraglutide. Curr Diab Rep 2010;10:124-32. DOI 10.1007/s11892-0.10-0102-x
10. Kim D, MacConell L, Zhuang D, et al. Effects of once weekly dosing of a long-acting release formulation of exenatide on glucose control and body weight in subjects with type 2 diabetes. Diabetes Care 2007;30:1487-93. DOI 10.2337/dc06-2375
11. Drucker DJ, Buse JB, Taylor K, et al. Exenatide once weekly versus twice daily for the treatment of type 2 diabetes: a randomised, open-label, non-inferiority study. Lancet 2008;372:1240-50. DOI 10.1016/S0140-6736(08)61206-4
12. Buse JB, Drucker DJ, Taylor KL, et al. DURATION-1: Exenatide once weekly produces sustained glycemic control and weight loss over 52 weeks. Diabetes Care 2010;33:1255-61. DOI 10.2337/dc09-1914
13. Bergenstal RM, Wysham C, MacConell L, et al. Efficacy and safety of exenatide once weekly versus sitagliptan or pioglitazone as an adjunct to metformin for treatment of type 2 diabetes (DURATION-2): a randomised trial. Lancet 2010;376:431-39. DOI 10.1016/S0140-6736(10)60590-9
14. Wysham C, Bergenstal R, Malloy J, et al. DURATION-2: efficacy and safety of switching from maximum daily sitagliptin or pioglitazone to once weekly exenatide. Diabet Med 2011;28:705-14. DOI 10.1111/j.1464-5491.2011.03301.x
15. 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;375:2234-43. DOI 10.1016/S0140-6736(10)60406-0
16. 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;96:1301-10. DOI 10.1210/jc.2010-2081
17. Seino Y, Nakajima H, Miyahara H, et al. Safety, tolerability, pharmacokinetics and pharmacodynamics of albiglutide, a long-acting GLP-1-receptor agonist, in Japanese subjects with type 2 diabetes mellitus. Curr Med Res Opin 2009;25:3049-57. DOI 10.1185/03007990903372999
18. Rosenstock J, Reusch J, Bush M, Yang F, Stewart M. Potential of albiglutide, a long-acting GLP-1 receptor agonist, in type 2 diabetes: a randomized controlled trial exploring weekly, biweekly, and monthly dosing. Diabetes Care 2009;32:1880-86. DOI 10.2337/dc09-0366
19. Nauck M, Ratner R, Kapitza C, Berria R, Boldrin M, Balena R. Treatment with the human once weekly glucagon-like peptide-1 analog taspoglutide in combination with metformin improves glycemic control and lowers body weight in patients with type 2 diabetes inadequately controlled with metformin alone. Diabetes Care 2009;32:1237-43. DOI 10.2337/dc08-1961
20. Ratner R, Nauck M, Kapitza C, Asnaghi V, Boldrin M, Balena R. Safety and tolerability of high doses of taspoglutide, a once weekly human GLP-1 analogue, in diabetic patients treated with metformin: a randomized double-blind placebo-controlled study. Diabet Med 2010;27:556-62. DOI 10.1111/j.1464-5491.2010.02990.x
21. Malone J, Trautmann M, Wilhelm K, Taylor K, Kendall DM. Exenatide once weekly for the treatment of type 2 diabetes. Expert Opin Investig Drugs 2009;18:359-67. DOI 10.1517/13543780902766802
22. Iwamoto K, Nasu R, Yamamura A, et al. Safety, tolerability, pharmacokinetics, and pharmacodynamics of exenatide once weekly in Japanese patients with type 2 diabetes. Endocr J 2009;56:951-62. DOI 10.1507/endocrj.K09E-147
23. Taylor K, Gurney K, Han J, Pencek R, Walsh B, Trautmann M. Exenatide once weekly treatment maintained improvements in glycemic control and weight loss over 2 years. BMC Endocrine Disorders 2011;11(1):1-9. DOI 10.1186/1476-6823-11-9
24. Best JH, Boye KS, Rubin RR, Cao D, Kim TH, Peyrot M. Improved treatment satisfaction and weight-related quality of life with exenatide once weekly or twice daily. Diabet Med 2009;26:722-28. DOI 10.1111/j.1464-5491.2009.02752.x
25. St Onge EL, Miller SA. Albiglutide: a new GLP-1 analog for the treatment of type 2 diabetes. Expert Opin Biol Ther 2010;10:801-6. DOI 10.1517/14712598.2010.481281
26. Matthes JE, Stewart MW, De Boever EH, et al. Pharmacodynamics, pharmacokinetics, safety, and tolerability of albiglutide, a long-acting glucagon-like peptide-1 mimetic, in patients with type 2 diabetes. J Clin Endocrinol Metab 2008;93:4810-17. DOI 10.1210/jc.2008-1518
27. Bush MA, Matthews JE, De Boever EH, et al. Safety, tolerability, pharmacodynamics and pharmacokinetics of albiglutide, a long-acting glucagon-like peptide-1 mimetic, in healthy subjects. Diabetes Obes Metab 2009;11:498-505. DOI 10.1111/j.1463-1326.2008.00992.x
28. Sebokova E, Christ AD, Wang H, et al. Taspoglutide, an analog glucagon-like peptide-1 with enhanced stability and in vivo potency. Endocrinology 2010;151:2474-82. DOI 10.1210/en.2009-1459
29. Cortez, MF. Roche Halts Taspoglutide Dosing in Final Studies. http://www.bloomberg.com/news/2010-09-10/roche-stops-giving-diabetesdrug-in-final-trial-over-nausea-side-effects.html (accessed 2010 Sep 13).
30. Retterstol K. Taspoglutide: a long-acting human glucagon-like polypeptide-1 analogue. Expert Opin Investig Drugs 2009;18:1405-11. DOI 10.1517/13543780903164205
31. Kapitza C, Heise T, Birman P, Jallet K, Ramis J, Balena R. Pharmacokinetic and pharmacodynamics properties of taspoglutide, a once weekly, human GLP-1 analogue, after single-dose administration in patients with type 2 diabetes. Diabet Med 2009;26:1156-64. DOI 10.1111/j.1464-5491.2009.02854.x
32. Nathan DM, Buse JB, Davidson MB, et al. Medical Management of Hyperglycemia in Type 2 Diabetes: A Consensus Algorithm for the Initiation and Adjustment of Therapy. Diabetes Care 2009;32:193-203. DOI 10.2337/dc08-9025
33. Glaesner W, Vick AM, Millican R, et al. Engineering and characterization of the long-acting glucagon-like peptide-1 analogue LY2189265, and Fc fusion protein. Diabetes Med Res Rev 2010;26:287-96. DOI 10.1002/dmrr.1080
34. Baggio LL, Huang Q, Cao X, Drucker DJ. An albumin-exendin-4 conjugate engages central and peripheral circuits regulating murine energy and glucose homeostasis. Gastroenterology 2008;134:1137-47. DOI 10.1053/j.gastro.2008.01.017
35. A study of dose titration of LY2189265 in overweight patients with type 2 diabetes mellitus (EGO). (Identifier: NCT00630825). www.clinicaltrials.gov (accessed 2011 Jul 26).
36. A study in patients with type 2 diabetes mellitus (AWARD-3). (Identifier: NCT01126580). www.clinicaltrials.gov (accessed 2011 Jul 26).
37. A study of LY2189265 compared to sitagliptin in patients with type 2 diabetes mellitus on metformin. (Identifier: NCT00734474). www.clinicaltrials.gov (accessed 2011 Jul 26).
38. Effects of LY2189265 on glycemic control in patients with type 2 diabetes. (Identifier: NCT00791479). www.clinicaltrials.gov (accessed 2011 Jul 26).
39. A study in patients with type 2 diabetes mellitus (AWARD-1). (Identifier: NCT01064687). www.clinicaltrials.gov (accessed 2011 Jul 26).
40. A study of LY2189265 in Japanese patients with type 2 diabetes. (Identifier: NCT01001104). www.clinicaltrials.gov (accessed 2011 Jul 26).
41. A study in patients with type 2 diabetes mellitus (AWARD-2). (Identifier: NCT01075282). www.clinicaltrials.gov (accessed 2011 Jul 26).
42. A study in patients with type 2 diabetes mellitus (AWARD-4). (Identifier: NCT01191268). www.clinicaltrials.gov (accessed 2011 Jul 26).
43. A study of the effect of LY2189265 on blood pressure and heart rate in type 2 diabetes. (Identifier: NCT01149421). www.clinicaltrials.gov (accessed 2011 Jul 26).
44. Researching cardiovascular events with a weekly incretin in diabetes (REWIND). (Identifier: NCT01394952). www.clinicaltrials.gov (accessed 2011 Jul 26).
45. A Study to Evaluate the Efficacy and Safety of CJC-1134-PC in Patients With Type 2 Diabetes Mellitus Who Are Currently on Metformin Monotherapy. (Identifier: NCT00638716). www.clinicaltrials.gov (accessed 2011 Jul 26).
46. A Study to Evaluate the Efficacy and Safety of CJC-1134-PC in Patients With Type 2 Diabetes Mellitus Who Are Currently on Metformin Monotherapy. (Identifier: NCT00674466). www.clinicaltrials.gov (accessed 2011 Jul 26).