Incretin-based Therapies for type 2 diabetes-comparisons between glucagon-like peptide-1 receptor agonists and dipeptidyl peptidase-4 inhibitors

US Endocrinology

Volumn 7, Issue 2, 2011, Pages 82-94

  Bailey, Timothy ^a  

^a AMCR Institute Inc   (United States)

Author keywords

Dipeptidyl peptidase 4; Exenatide; Fasting plasma glucose; Glucagon like peptide 1; Incretin; Linagliptin; Liraglutide; Saxagliptin; Sitagliptin; Type 2 diabetes

Indexed keywords

EID: 84868223416     PISSN: 17583918     EISSN: 17583926     Source Type: Journal    
DOI: 10.17925/use.2011.07.02.82     Document Type: Article

References (85)

1. CDCP CfDCaP, National Diabetes Fact Sheet: national estimates and general information on diabetes and prediabetes in the United States, 2011, Atlanta, GA: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, 2011.
2. UKPDS, Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33). UK Prospective Diabetes Study (UKPDS) Group, Lancet, 1998;352:837-53.
3. Gross JL, Kramer CK, Leitao CB, et al., Effect of antihyperglycemic agents added to metformin and a sulfonylurea on glycemic control and weight gain in type 2 diabetes: a network meta-analysis, Ann Intern Med, 2011;154:672-9.
4. 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: a consensus statement of the American Diabetes Association and the European Association for the Study of Diabetes, Diabetes Care, 2009;32:193-203.
5. Amylin, Byetta (exenatide BID) [prescribing information], San Diego, CA: Amylin Pharmaceuticals, Inc, 2010
6. BMS, Onglyza (saxagliptin) [prescribing information], Princeton, NJ: Bristol-Myers Squibb Co, 2011
7. Boehringer, Tradjenta (linagliptin) [prescribing information], Ridgefield, CT: Boehringer Ingelheim Pharmaceuticals, Inc, 2011
8. Merck, Januvia (sitagliptin) [prescribing information], Whitehouse Station, NJ: Merck & Co Inc, 2010
9. Novo, Victoza (liraglutide) [prescribing information], Princeton, NJ: Novo Nordisk Inc, 2011
10. Amori RE, Lau J, Pittas AG, Efficacy and safety of incretin therapy in type 2 diabetes: systematic review and metaanalysis, JAMA, 2007;298:194-206
11. Drucker DJ, Enhancing incretin action for the treatment of type 2 diabetes, Diabetes Care, 2003;26:2929-40
12. Vilsboll T, Krarup T, Madsbad S, et al., Defective amplification of the late phase insulin response to glucose by GIP in obese Type II diabetic patients, Diabetologia, 2002;45:1111-9.
13. Nauck MA, Heimesaat MM, Orskov C, et al., 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, J Clin Invest, 1993;91:301-7.
14. Herman GA, Bergman A, Stevens C, et al., Effect of single oral doses of sitagliptin, a dipeptidyl peptidase-4 inhibitor, on incretin and plasma glucose levels after an oral glucose tolerance test in patients with type 2 diabetes, J Clin Endocrinol Metab, 2006;91:4612-9.
15. Agersø H, Jensen LB, Elbrønd B, et al., The pharmacokinetics, pharmacodynamics, safety and tolerability of NN2211, a new long-acting GLP-1 derivative, in healthy men, Diabetologia, 2002;45:195-202.
16. Meier JJ, Gallwitz B, Siepmann N, et al., Gastric inhibitory polypeptide (GIP) dose-dependently stimulates glucagon secretion in healthy human subjects at euglycaemia, Diabetologia, 2003;46:798-801.
17. Näslund E, Bogefors J, Skogar S, et al., GLP-1 slows solid gastric emptying and inhibits insulin, glucagon, and PYY release in humans, Am J Physiol, 1999;277:R910-6.
18. Mentis N, Vardarli I, Köthe LD, et al., GIP does not potentiate the antidiabetic effects of GLP-1 in hyperglycemic patients with type 2 diabetes, Diabetes, 2011;60:1270-6.
19. Raz I, Hanefeld M, Xu L, et al., Efficacy and safety of the dipeptidyl peptidase-4 inhibitor sitagliptin as monotherapy in patients with type 2 diabetes mellitus, Diabetologia, 2006;49:2564-71.
20. Aschner P, Katzeff HL, Guo H, et al., Efficacy and safety of monotherapy of sitagliptin compared with metformin in patients with type 2 diabetes, Diabetes Obes Metab, 2010;12:252-61.
21. Goldstein BJ, Feinglos MN, Lunceford JK, et al., Effect of initial combination therapy with sitagliptin, a dipeptidyl peptidase-4 inhibitor, and metformin on glycemic control in patients with type 2 diabetes, Diabetes Care, 2007;30:1979-87.
22. Williams-Herman D, Johnson J, Teng R, et al., Efficacy and safety of sitagliptin and metformin as initial combination therapy and as monotherapy over 2 years in patients with type 2 diabetes, Diabetes Obes Metab, 2010;12:442-51.
23. Williams-Herman D, Johnson J, Teng R, et al., Efficacy and safety of initial combination therapy with sitagliptin and metformin in patients with type 2 diabetes: a 54-week study, Curr Med Res Opin, 2009;25:569-83.
24. Charbonnel B, Karasik A, Liu J, et al., Efficacy and safety of the dipeptidyl peptidase-4 inhibitor sitagliptin added to ongoing metformin therapy in patients with type 2 diabetes inadequately controlled with metformin alone, Diabetes Care, 2006;29:2638-43.
25. Nauck MA, Meininger G, Sheng D, et al., Efficacy and safety of the dipeptidyl peptidase-4 inhibitor, sitagliptin, compared with the sulfonylurea, glipizide, in patients with type 2 diabetes inadequately controlled on metformin alone: a randomized, double-blind, non-inferiority trial, Diabetes Obes Metab, 2007;9:194-205.
26. Seck T, Nauck M, Sheng D, et al., Safety and efficacy of treatment with sitagliptin or glipizide in patients with type 2 diabetes inadequately controlled on metformin: a 2-year study, Int J Clin Pract, 2010;64:562-76.
27. Arechavaleta R, Seck T, Chen Y, et al., Efficacy and safety of treatment with sitagliptin or glimepiride in patients with type 2 diabetes inadequately controlled on metformin monotherapy: a randomized, double-blind, non-inferiority trial, Diabetes Obes Metab, 2011;13:160-8.
28. Scott R, Loeys T, Davies MJ, et al., Efficacy and safety of sitagliptin when added to ongoing metformin therapy in patients with type 2 diabetes, Diabetes Obes Metab, 2008;10:959-69.
29. Rosenstock J, Brazg R, Andryuk PJ, et al., Efficacy and safety of the dipeptidyl peptidase-4 inhibitor sitagliptin added to ongoing pioglitazone therapy in patients with type 2 diabetes: a 24-week, multicenter, randomized, double-blind, placebo-controlled, parallel-group study, Clin Ther, 2006;28:1556-68.
30. Yoon KH, Shockey GR, Teng R, et al., Effect of initial combination therapy with sitagliptin, a dipeptidyl peptidase-4 inhibitor, and pioglitazone on glycemic control and measures of beta-cell function in patients with type 2 diabetes, Int J Clin Pract, 2011;65:154-64.
31. Hermansen K, Kipnes M, Luo E, et al., Efficacy and safety of the dipeptidyl peptidase-4 inhibitor, sitagliptin, in patients with type 2 diabetes mellitus inadequately controlled on glimepiride alone or on glimepiride and metformin, Diabetes Obes Metab, 2007;9:733-45.
32. Vilsboll T, Rosenstock J, Yki-Jarvinen H, et al., Efficacy and safety of sitagliptin when added to insulin therapy in patients with type 2 diabetes, Diabetes Obes Metab, 2010;12:167-77.
33. Chacra AR, Tan GH, Ravichandran S, et al., Safety and efficacy of saxagliptin in combination with submaximal sulphonylurea versus up-titrated sulphonylurea over 76 weeks, Diab Vasc Dis Res, 2011;8:150-9.
34. DeFronzo RA, Hissa MN, Garber AJ, et al., The efficacy and safety of saxagliptin when added to metformin therapy in patients with inadequately controlled type 2 diabetes with metformin alone, Diabetes Care, 2009;32:1649-55.
35. Goke B, Gallwitz B, Eriksson J, et al., Saxagliptin is non-inferior to glipizide in patients with type 2 diabetes mellitus inadequately controlled on metformin alone: a 52-week randomised controlled trial, Int J Clin Pract, 2010;64:1619-31.
36. Hollander PL, Li J, Frederich R, et al., Safety and efficacy of saxagliptin added to thiazolidinedione over 76 weeks in patients with type 2 diabetes mellitus, Diab Vasc Dis Res, 2011;8:125-35.
37. Jadzinsky M, Pfutzner A, Paz-Pacheco E, et al., Saxagliptin given in combination with metformin as initial therapy improves glycaemic control in patients with type 2 diabetes compared with either monotherapy: a randomized controlled trial, Diabetes Obes Metab, 2009;11:611-22.
38. Karyekar C, Donovan M, Allen E, et al., Efficacy and safety of saxagliptin combination therapy in US patients with type 2 diabetes, Postgrad Med, 2011;123:63-70.
39. Pfutzner A, Paz-Pacheco E, Allen E, et al., Initial combination therapy with saxagliptin and metformin provides sustained glycaemic control and is well tolerated for up to 76 weeks, Diabetes Obes Metab, 2011;13:567-76.
40. Rosenstock J, Aguilar-Salinas C, Klein E, et al., Effect of saxagliptin monotherapy in treatment-naive patients with type 2 diabetes, Curr Med Res Opin, 2009;25:2401-11.
41. Chacra AR, Tan GH, Apanovitch A, et al., Saxagliptin added to a submaximal dose of sulphonylurea improves glycaemic control compared with uptitration of sulphonylurea in patients with type 2 diabetes: a randomised controlled trial, Int J Clin Pract, 2009;63:1395-406.
42. Hollander P, Li J, Allen E, et al., Saxagliptin added to a thiazolidinedione improves glycemic control in patients with type 2 diabetes and inadequate control on thiazolidinedione alone, J Clin Endocrinol Metab, 2009;94:4810-9.
43. Del Prato S, Barnett AH, Huisman H, et al., Effect of linagliptin monotherapy on glycaemic control and markers of beta-cell function in patients with inadequately controlled type 2 diabetes: a randomized controlled trial, Diabetes Obes Metab, 2011;13:258-67.
44. Taskinen MR, Rosenstock J, Tamminen I, et al., Safety and efficacy of linagliptin as add-on therapy to metformin in patients with type 2 diabetes: a randomized, double-blind, placebo-controlled study, Diabetes Obes Metab, 2011;13:65-74.
45. Forst T, Uhlig-Laske B, Ring A, et al., Linagliptin (BI 1356), a potent and selective DPP-4 inhibitor, is safe and efficacious in combination with metformin in patients with inadequately controlled Type 2 diabetes, Diabet Med, 2010;27:1409-19.
46. Gomis R, Espadero RM, Jones R, et al., Efficacy and safety of initial combination therapy with linagliptin and pioglitazone in patients with inadequately controlled type 2 diabetes: a randomized, double-blind, placebo-controlled study, Diabetes Obes Metab, 2011;13:653-61.
47. Owens DR, Swallow R, Dugi KA, Woerle HJ, Efficacy and safety of linagliptin in persons with Type 2 diabetes inadequately controlled by a combination of metformin and sulphonylurea: a 24-week randomized study, Diabet Med, 2011;28:1352-61
48. Moretto TJ, Milton DR, Ridge TD, et al., Efficacy and tolerability of exenatide monotherapy over 24 weeks in antidiabetic drug-naive patients with type 2 diabetes: a randomized, double-blind, placebo-controlled, parallel-group study, Clin Ther, 2008;30:1448-60.
49. Buse JB, Henry RR, Han J, et al., Effects of exenatide (exendin-4) on glycemic control over 30 weeks in sulfonylurea-treated patients with type 2 diabetes, Diabetes Care, 2004;27:2628-35.
50. DeFronzo RA, Ratner RE, Han J, et al., Effects of exenatide (exendin-4) on glycemic control and weight over 30 weeks in metformin-treated patients with type 2 diabetes, Diabetes Care, 2005;28:1092-100.
51. Kendall DM, Riddle MC, Rosenstock J, et al., Effects of exenatide (exendin-4) on glycemic control over 30 weeks in patients with type 2 diabetes treated with metformin and a sulfonylurea, Diabetes Care, 2005;28:1083-91.
52. Zinman B, Hoogwerf BJ, Duran Garcia S, et al., The effect of adding exenatide to a thiazolidinedione in suboptimally controlled type 2 diabetes: a randomized trial, Ann Intern Med, 2007;146:477-85.
53. Buse JB, Rosenstock J, Sesti G, et al., 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.
54. Buse JB, Sesti G, Schmidt WE, et al., Switching to once-daily liraglutide from twice-daily exenatide further improves glycemic control in patients with type 2 diabetes using oral agents, Diabetes Care, 2010;33:1300-3.
55. Garber A, Henry R, Ratner R, et al., Liraglutide versus glimepiride monotherapy for type 2 diabetes (LEAD-3 Mono): a randomised, 52-week, phase III, double-blind, paralleltreatment trial, Lancet, 2009;373:473-81.
56. Garber A, Henry RR, Ratner R, et al., Liraglutide, a once-daily human glucagon-like peptide 1 analogue, provides sustained improvements in glycaemic control and weight for 2 years as monotherapy compared with glimepiride in patients with type 2 diabetes, Diabetes Obes Metab, 2011;13:348-56.
57. Marre M, Shaw J, Brandle M, et al., Liraglutide, a once-daily human GLP-1 analogue, added to a sulphonylurea over 26 weeks produces greater improvements in glycaemic and weight control compared with adding rosiglitazone or placebo in subjects with Type 2 diabetes (LEAD-1 SU), Diabet Med, 2009;26:268-78.
58. Nauck M, Frid A, Hermansen K, et al., 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.
59. Russell-Jones D, Vaag A, Schmitz O, et al., 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;52:2046-55.
60. Zinman B, Gerich J, Buse JB, et al., 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;32:1224-30.
61. Nauck MA, Vilsboll T, Gallwitz B, et al., Incretin-based therapies: viewpoints on the way to consensus, Diabetes Care, 2009;32(Suppl. 2):S223-31.
62. Davies M, Pratley R, Hammer M, et al., Liraglutide improves treatment satisfaction in people with Type 2 diabetes compared with sitagliptin, each as an add on to metformin, Diabet Med, 2011;28:333-7.
63. Davies MJ, Chubb BD, Smith IC, et al., Cost-utility analysis of liraglutide compared with sulphonylurea or sitagliptin, all as add-on to metformin monotherapy in Type 2 diabetes mellitus, Diabet Med, 2011; epub ahead of print.
64. DeFronzo RA, Okerson T, Viswanathan P, et al., 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;24:2943-52.
65. Berg JK, Shenouda SK, Heilmann CR, et al., Effects of exenatide twice daily versus sitagliptin on 24-h glucose, glucoregulatory and hormonal measures: a randomized, double-blind, crossover study, Diabetes Obes Metab, 2011;13:982-9.
66. Pratley RE, Nauck M, Bailey T, et al., Liraglutide versus sitagliptin 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;375:1447-56.
67. Buse B, Nauck MA, Forst T, et al., Efficacy and safety of exenatide once weekly versus liraglutide in subjects with type 2 diabetes (DURATION-6): a randomised, open-label study, Abstract 75, Diabetologia, 2011;54:S38.
68. Drucker DJ, Sherman SI, Bergenstal RM, et al., The safety of incretin-based therapies-review of the scientific evidence, J Clin Endocrinol Metab, 2011;96:2027-31.
69. Garg R, Chen W, Pendergrass M, Acute pancreatitis in type 2 diabetes treated with exenatide or sitagliptin: a retrospective observational pharmacy claims analysis, Diabetes Care, 2010;33:2349-54
70. Parks M, Rosebraugh C, Weighing risks and benefits of liraglutide-the FDA's review of a new antidiabetic therapy, N Engl J Med, 2010;362:774-7
71. Bjerre Knudsen L, Madsen LW, Andersen S, et al., Glucagon-like Peptide-1 receptor agonists activate rodent thyroid C-cells causing calcitonin release and C-cell proliferation, Endocrinology, 2010;151:1473-86.
72. Vilsboll T, Zdravkovic M, Le-Thi T, et al., Liraglutide, a longacting human glucagon-like peptide-1 analog, given as monotherapy significantly improves glycemic control and lowers body weight without risk of hypoglycemia in patients with type 2 diabetes, Diabetes Care, 2007;30:1608-10.
73. Pannacciulli N, Le DS, Salbe AD, et al., Postprandial glucagonlike peptide-1 (GLP-1) response is positively associated with changes in neuronal activity of brain areas implicated in satiety and food intake regulation in humans, Neuroimage, 2007;35:511-7.
74. Best JH, Rubin RR, Peyrot M, et al., Weight-related quality of life, health utility, psychological well-being, and satisfaction with exenatide once weekly compared with sitagliptin or pioglitazone after 26 weeks of treatment, Diabetes Care, 2011;34:314-9.
75. Corsonello A, Pedone C, Corica F, et al., Concealed renal failure and adverse drug reactions in older patients with type 2 diabetes mellitus, J Gerontol A Biol Sci Med Sci, 2005;60:1147-51.
76. Koro CE, Lee BH, Bowlin SJ, Antidiabetic medication use and prevalence of chronic kidney disease among patients with type 2 diabetes mellitus in the United States, Clin Ther, 2009;31:2608-17
77. Davidson JA, Brett J, Falahati A, et al., Mild renal impairment and the efficacy and safety of liraglutide, Endocr Pract, 2011;17:345-55.
78. Polster M, Zanutto E, McDonald S, et al., A comparison of preferences for two GLP-1 products-liraglutide and exenatide-for the treatment of type 2 diabetes, J Med Econ, 2010;13:655-61.
79. Zinman B, Schmidt WE, Moses A, et al., Achieving a clinically relevant composite outcome of an HbA(1c) of <7% without weight gain or hypoglycaemia in type 2 diabetes: a metaanalysis of the liraglutide clinical trial programme, Diabetes Obes Metab, 2012;14:77-82.
80. Kielgast U, Krarup T, Holst JJ, et al., Four weeks of treatment with liraglutide reduces insulin dose without loss of glycemic control in type 1 diabetic patients with and without residual beta-cell function, Diabetes Care, 2011;34:1463-8.
81. Raman VS, Mason KJ, Rodriguez LM, et al., The role of adjunctive exenatide therapy in pediatric type 1 diabetes, Diabetes Care, 2010;33:1294-6.
82. Varanasi A, Bellini N, Rawal D, et al., Liraglutide as additional treatment for type 1 diabetes, Eur J Endocrinol, 2011;165:77-84.
83. DeFronzo RA, Banting Lecture. From the triumvirate to the ominous octet: a new paradigm for the treatment of type 2 diabetes mellitus, Diabetes, 2009;58:773-95.
84. Forst T, Uhlig-Laske B, Ring A, et al., The oral DPP-4 inhibitor linagliptin significantly lowers HbA1c after 4 weeks of treatment in patients with type 2 diabetes mellitus, Diabetes Obes Metab, 2011;13:542-50.
85. Pratley R, Nauck M, Bailey T, et al., One year of liraglutide treatment offers sustained and more effective glycaemic control and weight reduction compared with sitagliptin, both in combination with metformin, in patients with type 2 diabetes: a randomised, parallel-group, open-label trial, Int J Clin Pract, 2011;65:397-407.