Alogliptin benzoate for the treatment of type 2 diabetes

Expert Opinion on Pharmacotherapy

Volumn 15, Issue 6, 2014, Pages 851-863

  Seino, Yutaka ^a   Yabe, Daisuke ^a  

^a KANSAI ELECTRIC POWER CO   (Japan)

Author keywords

Alogliptin; Dipeptidyl peptidase 4 inhibitor; Glycemic control; Type 2 diabetes

Indexed keywords

ALOGLIPTIN; ANTIDIABETIC AGENT; DIPEPTIDYL PEPTIDASE IV INHIBITOR;

ARTHRALGIA; ARTICLE; BACKACHE; BRONCHITIS; CEREBROVASCULAR ACCIDENT; DIABETIC PATIENT; DIARRHEA; DIZZINESS; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; DYSLIPIDEMIA; GASTROINTESTINAL SYMPTOM; GLYCEMIC CONTROL; HEADACHE; HEART INFARCTION; HUMAN; HYPERGLYCEMIA; HYPERTENSION; HYPOGLYCEMIA; INFECTION; INFESTATION; INFLUENZA; MONOTHERAPY; NON INSULIN DEPENDENT DIABETES MELLITUS; NONHUMAN; PERIPHERAL EDEMA; RANDOMIZED CONTROLLED TRIAL (TOPIC); RHINOPHARYNGITIS; RISK ASSESSMENT; SIDE EFFECT; SKIN TOXICITY; UPPER RESPIRATORY TRACT INFECTION; URINARY TRACT INFECTION; WEIGHT GAIN;

BLOOD GLUCOSE; DIABETES MELLITUS, TYPE 2; DIPEPTIDYL-PEPTIDASE IV INHIBITORS; DRUG THERAPY, COMBINATION; HUMANS; HYPERGLYCEMIA; HYPOGLYCEMIC AGENTS; PIPERIDINES; URACIL;

EID: 84896484411     PISSN: 14656566     EISSN: 17447666     Source Type: Journal    
DOI: 10.1517/14656566.2014.898750     Document Type: Article

References (89)

1. Asian Association for the Study of Diabetes. Promoting research for better diabetes care in Asia: Kyoto Declaration on Diabetes. J Diabetes Investig 2013;4:222
2. International Diabetes Federation. IDF Diabetes Atlas. 6th edition. Brussels, Belgium: International Diabetes Federation. 2013. Available from www.idf.org/diabetesatlas [Last accessed 13 December 2013]
3. Schunk M, Reitmeir P, Schipf S, et al. Health-related quality of life in subjects with and without type 2 diabetes: pooled analysis of five population-based surveys in Germany. Diabet Med 2012;29:646-53
4. Hotta N, Nakamura J, Iwamoto Y, et al. Causes of death in Japanese diabetics: a questionnaire survey of 18, 385 diabetics over a 10-year period. J Diabetes Investig 2010;1:66-76
5. Hex N, Bartlett C, Wright D, et al. Estimating the current and future costs of type 1 and type 2 diabetes in the UK, including direct health costs and indirect societal and productivity costs. Diabet Med 2012;29:855-62
6. American Diabetes Association. Economic costs of diabetes in the U.S. in 2012. Diabetes Care 2013;36:1033-46
7. Lee CM, Colagiuri R, Magliano DJ, et al. The cost of diabetes in adults in Australia. Diabetes Res Clin Pract 2013;99:385-90
8. Barnett G. Economic and social impact of diabetes, what to do (abstract HE-02-3). J Diabetes Investig 2012;3(Suppl 1):67
9. Bailey T. Options for combination therapy in type 2 diabetes: comparison of the ADA/EASD position statement and AACE/ACE algorithm. Am J Med 2013;126:S10-20
10. Turner RC, Cull CA, Frighi V, Holman RR. Glycemic control with diet, sulfonylurea, metformin, or insulin in patients with type 2 diabetes mellitus: progressive requirement for multiple therapies (UKPDS 49). UK Prospective Diabetes Study (UKPDS) Group. JAMA 1999;281:2005-12
11. Inzucchi SE, Bergenstal RM, Buse JB, et al. 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;35:1364-79
12. Chow FCC, Chan S-P, Hwu C-M, et al. Challenges in achieving optimal glycemic control in type 2 diabetes patients with declining renal function: the Southeast Asia perspective. J Diabetes Investig 2012;3:481-9
13. Fukushima M, Suzuki H, Seino Y. Insulin secretion capacity in the development from normal glucose tolerance to type 2 diabetes. Diabetes Res Clin Pract 2004;66:S37-43
14. Fukushima M, Aoyama S, Taniguchi A, Seino Y. Clinical characteristics of Asian diabetics: in view of insulin secretory defect and insulin resistance (abstract CS-15-4). J Diabetes Investig 2012;3(Suppl 1):54
15. Iwahashi H, Okauchi Y, Ryo M, et al. Insulin-secretion capacity in normal glucose tolerance, impaired glucose tolerance, and diabetes in obese and non-obese Japanese patients. J Diabetes Investig 2012;3:271-5
16. Seino Y, Fukushima M, Yabe D. GIP and GLP-1, the two incretin hormones: similarities and differences. J Diabetes Investig 2010;1:8-23
17. Seino Y, Yabe D. Glucose-dependent insulinotropic polypeptide and glucagon-like peptide-1: incretin actions beyond the pancreas. J Diabetes Investig 2013;4:108-30
18. Campbell JE, Drucker DJ. Pharmacology, physiology, and mechanisms of incretin hormone action. Cell Metab 2013;17:819-37
19. Cox ME, Rowell J, Corsino L, Green JB. Dipeptidyl peptidase-4 inhibitors in the management of type 2 diabetes: safety, tolerability, and efficacy. Drug Healthc Patient Saf 2010;2:7-19
20. Goofien K, Graber S. Longer term safety of dipeptidyl peptidase-4 inhibitors in patients with type 2 diabetes mellitus: systematic review and meta-Analysis. Diabetes Obes Metab 2012;14:1061-72
21. Yabe D, Seino Y. Dipeptidyl peptidase-4 inhibitors and prevention of bone fractures: effects beyond glycemic control. J Diabetes Investig 2012;3:347-8
22. Ahren B. DPP-4 inhibition and islet function. J Diabetes Investig 2012;3:3-10
23. Wajchenberg BL. Beta-cell failure in diabetes and preservation by clinical treatment. Endocr Rev 2007;28:187-218
24. Feng J, Zhang Z, Wallace MB, et al. Discovery of alogliptin: a potent, selective, bioavailable, and efficacious inhibitor of dipeptidyl peptidase IV. J Med Chem 2007;50:2297-300
25. Christopher R, Covington P, Davenport M, et al. Pharmacokinetics, pharmacodynamics, and tolerability of single increasing doses of the dipeptidyl peptidase-4 inhibitor alogliptin in healthy male subjects. Clin Ther 2008;30:513-27
26. Moritoh Y, Takeuchi K, Asakawa T, et al. Chronic administration of alogliptin, a novel, potent, and highly selective dipeptidyl peptidase-4 inhibitor, improves glycemic control and beta-cell function in obese diabetic ob/ob mice. Eur J Pharmacol 2008;588:325-32
27. Lee B, Shi L, Kassel DB, et al. Pharmacokinetic, pharmacodynamic, and efficacy profiles of alogliptin, a novel inhibitor of dipeptidyl peptidase-4, in rats, dogs, and monkeys.
28. Eur J Pharmacol 2008;589:306-14
29. Asakawa T, Moritoh Y, Kataoka O, et al. A novel dipeptidyl peptidase-4 inhibitor, alogliptin (SYR-322), is effective in diabetic rats with sulfonylurea-induced secondary failure. Life Sci 2009;85:122-6
30. Shah Z, Kampfrath T, Deiuliis JA, et al. Long-term dipeptidyl-peptidase 4 inhibition reduces atherosclerosis and inflammation via effects on monocyte recruitment and chemotaxis. Circulation 2011;124:2338-49
31. Ta NN, Schuyler CA, Li Y, et al. DPP-4 (CD26) inhibitor alogliptin inhibits atherosclerosis in diabetic apolipoprotein E-deficient mice. J Cardiovasc Pharmacol 2011;58:157-66
32. Ta NN, Li Y, Schuyler CA, et al. DPP-4 (CD26) inhibitor alogliptin inhibits TLR4-mediated ERK activation and ERK-dependent MMP-1 expression by U937 histiocytes. Atherosclerosis 2010;213:429-35
33. Covington P, Christopher R, Davenport M, et al. Pharmacokinetic, pharmacodynamic, and tolerability profiles of the dipeptidyl peptidase-4 inhibitor alogliptin: a randomized, double-blind, placebo-controlled, multiple-dose study in adult patients with type 2 diabetes. Clin Ther 2008;30:499-512
34. Karim A, Covington P, Christopher R, et al. Pharmacokinetics of alogliptin when administered with food, metformin, or cimetidine: a two-phase, crossover study in healthy subjects. Int J Clin Pharmacol Ther 2010;48:46-58
35. Karim A, Bridson W, Fleck P, et al. Disposition of the dipeptidyl peptidase-4 inhibitor [14C] alogliptin benzoate ([14C]SYR-322) after oral administration to healthy male subjects [abstract]. AAPSJ 2007;9:T3552
36. Karim A, Fleck P, Harrell RE, et al. Effects of age, race and gender on the pharmacokinetics and pharmacodynamics of alogliptin, a novel and highly selective dipeptidyl peptidase-4 inhibitor in healthy subjects [abstract PI-14]. Clin Pharmacol Ther 2008;83(Suppl):S13
37. Karim A, Laurent A, Munsaka M, et al. Coadministration of pioglitazone or glyburide and alogliptin: pharmacokinetic drug interaction assessment in healthy participants. J Clin Pharmacol 2009;49:1210-19
38. Karim A, Harris S, Fleck P, et al. Effect of fluconazole, ketoconazole, and gemfibrozil on the pharmacokinetics of alogliptin benzoate (SYR-322) in healthy subjects [abstract 105]. J Clin Pharmacol 2007;47:1207
39. Karim A, Fleck P, Harris S, et al. Lack of pharmacokinetic interaction between multiple doses of the dipeptidyl peptidase-4 inhibitor alogliptin and digoxin in healthy subjects [abstract PI-13]. Clin Pharmacol Ther 2008;83(Suppl):S12-13
40. Karim A, Chiselko P, Fleck P, et al. Lack of effect of cyclosporine on the single-dose pharamacokinetics of alogliptin, a novel dipeptidyl peptidase-4 inhibitor in healthy male subjects [abstract PI-15]. Clin Pharmacol Ther 2008;83(Suppl):S13
41. Karim A, Copa A, Fleck P, et al. Effect of alogliptin on the pharmacokinetics and pharmacodynamics of norethindrone Oh ® and ethinyl estradiol (rto-Novum 1/35) in healthy adult female subjects [abstract PI-16]. Clin Pharmacol Ther 2008;83(Suppl):S14
42. Karim S, Fleck P, Harris S, et al. Assessment of drug interaction between alogliptin, a highly selective dipeptidyl peptidase-4 inhibitor, and atorvastatin in healthy subjects [abstract PI-17]. Clin Pharmacol Ther 2008;83(Suppl):S14
43. Karim A, Harris S, Fleck P, et al. Assessment of drug interactions between alogliptin benzoate (SYR-322), a highly selective dipeptidyl peptidase-4 inhibitor, and warfarin at steady state [abstract 106]. J Clin Pharmacol 2007;47:1207
44. Berhan A, Berhan Y. Efficacy of alogliptin in type 2 diabetes treatment: a meta-Analysis of randomized double-blind controlled studies. BMC Endocr Disord 2013;13:9
45. Seino Y, Fujita T, Hiroi S, et al. Efficacy and safety of alogliptin in Japanese patients with type 2 diabetes mellitus: a randomized, double-blind, dose-ranging comparison with placebo, followed by a long-term extension study. Curr Med Res Opin 2011;27:1781-92
46. DeFronzo RA, Fleck PR, Wilson CA, Mekki Q; Alogliptin Study 010 Group. Efficacy and safety of the dipeptidyl peptidase-4 inhibitor alogliptin in patients with type 2 diabetes and inadequate glycemic control: a randomized, double-blind, placebo-controlled study. Diabetes Care 2008;31:2315-17
47. Rosenstock J, Wilson C, Fleck P. Alogliptin versus glipizide monotherapy in elderly type 2 diabetes mellitus patients with mild hyperglycaemia: a prospective, double-blind, randomized, 1-year study. Diabetes Obes Metab 2013;15:906-14
48. Kutoh E, Ukai Y. Alogliptin as an initial therapy in patients with newly diagnosed, drug näive type 2 diabetes: a randomized, control trial. Endocrine 2012;41:435-41
49. Rosenstock J, Rendell MS, Gross JL, et al. Alogliptin added to insulin therapy in patients with type 2 diabetes reduces HbA(1C) without causing weight gain or increased hypoglycaemia. Diabetes Obes Metab 2009;11:1145-52
50. Nauck MA, Ellis GC, Fleck PR, et al. Efficacy and safety of adding the dipeptidyl peptidase-4 inhibitor alogliptin to metformin therapy in patients with type 2 diabetes inadequately controlled with metformin monotherapy: a multicentre, randomised, double-blind, placebo-controlled study. Int J Clin Pract 2009;63:46-55
51. Seino Y, Miyata Y, Hiroi S, et al. Efficacy and safety of alogliptin added to metformin in Japanese patients with type 2 diabetes: a randomized, double-blind, placebo-controlled trial with an open-label, long-term extension study. Diabetes Obes Metab 2012;14:927-36
52. Pratley RE, Kipnes MS, Fleck PR, et al. Efficacy and safety of the dipeptidyl peptidase-4 inhibitor alogliptin in patients with type 2 diabetes inadequately controlled by glyburide monotherapy. Diabetes Obes Metab 2009;11:167-76
53. Seino Y, Hiroi S, Hirayama M, Kaku K. Efficacy and safety of alogliptin added to sulfonylurea in Japanese patients with type 2 diabetes: a randomized, double-blind, placebo-controlled trial with an open-label, long-term extension study. J Diabetes Invest 2012;3:517-25
54. Pratley RE, Reusch JE, Fleck PR, et al. Efficacy and safety of the dipeptidyl peptidase-4 inhibitor alogliptin added to pioglitazone in patients with type 2 diabetes: a randomized, double-blind, placebo-controlled study. Curr Med Res Opin 2009;25:2361-71
55. Kaku K, Itayasu T, Hiroi S, et al. Efficacy and safety of alogliptin added to pioglitazone in Japanese patients with type 2 diabetes: a randomized, double-blind, placebo-controlled trial with an open-label long-term extension study. Diabetes Obes Metab 2011;13:1028-35
56. Seino Y, Fujita T, Hiroi S, et al. Alogliptin plus voglibose in Japanese patients with type 2 diabetes: a randomized, double-blind, placebo-controlled trial with an open-label, long-term extension. Curr Med Res Opin 2011;27(Suppl 3):21-9
57. Del Prato S, Camisasca R, Wilson C, Fleck P. Durability of the efficacy and safety of alogliptin compared to glipizide over 2 years when used in combination with metformin [poster 66-LB]. 73rd Scientific Sessions of the American iabetes Association. 2013 Jun 21-5;Chicago, USA. Available from: http://ada.apprisor.org/epsSearch. cfm?compid=1 [Last accessed 2 December 2013]
58. Masuda K, Aoki K, Kamiko K, et al. Glycemic control after addition of the dipeptidyl peptidase-4 inhibitor alogliptin in patients with type 2 diabetes showing inadequate response to thrice-A-day treatment with alpha-glucosidase inhibitors. Expert Opin Pharmacother 2013;14:1111-18
59. DeFronzo RA, Burant CF, Fleck P, et al. Efficacy and tolerability of the DPP-4 inhibitor alogliptin combined with pioglitazone, in metformin-treated patients with type 2 diabetes. J Clin Endocrinol Metab 2012;97:1615-22
60. Bosi E, Ellis GC, Wilson CA, Fleck PR. Alogliptin as a third oral antidiabetic drug in patients with type 2 diabetes and inadequate glycaemic control on metformin and pioglitazone: a 52-week, randomized, double-blind, active-controlled, parallel-group study. Diabetes Obes Metab 2011;13:1088-96
61. Rosenstock J, Inzucchi SE, Seufert J, et al. Initial combination therapy with alogliptin and pioglitazone in drug-näive patients with type 2 diabetes. Diabetes Care 2010;33:2406-8
62. Pratley RE, McCall T, Fleck PR, et al. Alogliptin use in elderly people: a pooled analysis from phase 2 and 3 studies. J Am Geriatr Soc 2009;57:2011-19
63. Fujii Y, Abe M, Higuchi T, et al. The dipeptidyl peptidase-4 inhibitor alogliptin improves glycemic control in type 2 diabetic patients undergoing hemodialysis. Expert Opin Pharmacother 2013;14:259-67
64. Nakamura Y, Inagaki M, Shimizu T, et al. Long-term effects of alogliptin benzoate in hemodialysis patients with diabetes: a 2-year study. Nephron Clin Pract 2013;123:46-51
65. Matikainen N, Mänttäri S, Schweizer A, et al. Vildagliptin therapy reduces postprandial intestinal triglyceride-rich lipoprotein particles in patients with type 2 diabetes. Diabetologia 2006;49:2049-57
66. Tremblay AJ, Lamarche B, Deacon CF, et al. Effect of sitagliptin therapy on postprandial lipoprotein levels in patients with type 2 diabetes. Diabetes Obes Metab 2011;13:366-73
67. Xiao C, Bandsma RH, Dash S, et al. Exenatide, a glucagon-like peptide-1 receptor agonist, acutely inhibits intestinal lipoprotein production in healthy humans. Arterioscler Thromb Vasc Biol 2012;32:1513-19
68. Eliasson B, Möller-Goede D, Eeg-Olofsson K, et al. Lowering of postprandial lipids in individuals with type 2 diabetes treated with alogliptin and/or pioglitazone: a randomised double-blind placebo-controlled study. Diabetologia 2012;55:915-25
69. White WB, Cannon CP, Heller SR, et al. Alogliptin after acute coronary syndrome in patients with type 2 diabetes. N Engl J Med 2013;369:1327-35
70. Noda Y, Miyoshi T, Oe H, et al. Alogliptin ameliorates postprandial lipemia and postprandial endothelial dysfunction in non-diabetic subjects: a preliminary report. Cardiovasc Diabetol 2013;12:8
71. Vipidia: EPAR-Public assessment report. European Medicines Agency. 2013. Available from: www.ema.europa. eu [Last accessed 22 November 2013]
72. Drucker DJ, Sherman SI, Gorelick FS, et al. Incretin-based therapies for the treatment of type 2 diabetes: evaluation of the risks and benefits. Diabetes Care 2010;33:428-33
73. Capuano A, Sportiello L, Maiorino MI, et al. Dipeptidyl peptidase-4 inhibitors in type 2 diabetes therapy-focus on alogliptin. Drug Des Devel Ther 2013;7:989-1001
74. White WB, Pratley R, Fleck P, et al. Cardiovascular safety of the dipetidyl peptidase-4 inhibitor alogliptin in type 2 diabetes mellitus. Diabetes Obes Metab 2013;15:668-73
75. Esposito K, Cozzolino D, Bellastella G, et al. Dipeptidyl peptidase-4 inhibitors and HbA1c target of <7% in type 2 diabetes: meta-Analysis of randomized controlled trials. Diabetes Obes Metab 2011;13:594-603
76. Kim YG, Hahn S, Oh TJ, et al. Differences in the glucose-lowering efficacy of dipeptidyl peptidase-4 inhibitors between Asians and non-Asians: a systematic review and meta-Analysis. Diabetologia 2013;56:696-708
77. Iwasaki M, Hoshian F, Tsuji T, et al. Predicting efficacy of dipeptidyl peptidase-4 inhibitors in patients with type 2 diabetes: association of glycated hemoglobin reduction with serum eicosapentaenoic acid and docosahexaenoic acid levels. J Diabetes Investig 2012;3:464-7
78. Senmaru T, Fukui M, Kobayashi K, et al. Dipeptidyl-peptidase IV inhibitor is effective in patients with type 2 diabetes with high serum eicosapentaenoic acid concentrations. J Diabetes Investig 2012;3:498-502
79. Kubota A, Matsuba I, Saito T, et al. Secretory units of islets in transplantation index is a useful clinical marker to evaluate the efficacy of sitagliptin in treatment of type 2 diabetes mellitus. J Diabetes Investig 2011;2:377-80
80. Kubota A, Yabe D, Kanamori A, et al. Factors influencing durability of the glucose-lowering effect of sitagliptin combined with a sulfonylurea. J Diabetes Investig 2013. [Epub ahead of print]
81. Kozawa J, Kitamura T, Nishizawa H, et al. Dipeptidyl peptidase-4 inhibitors are effective in Japanese type 2 diabetic patients with sustained endogenous insulin-secreting capacity, a higher body mass index and insulin resistance. J Diabetes Investig 2013;4:190-4
82. Bando Y, Kanehara H, Aoki K, et al. Obesity may attenuate the HbA1c-lowering effect of sitagliptin in Japanese type 2 diabetic patients. J Diabetes Investig 2012;3:170-4
83. Hamaguchi T, Koga M, Murai J, et al. Estimation of HbA1c response to sitagliptin by change in glycated albumin level for 2 weeks. J Diabetes Investig 2012;3:175-8
84. Yabe D, Kuroe A, Lee S, et al. Little enhancement of meal-induced glucagon-like peptide 1 secretion in Japanese: Comparison of type 2 diabetes patients and healthy controls. J Diabetes Investig 2010;1:56-9
85. Aaboe K, Knop FK, VilsbØll T, et al. Twelve weeks treatment with the DPP-4 inhibitor, sitagliptin, prevents degradation of peptide YY and improves glucose and non-glucose induced insulin secretion in patients with type 2 diabetes mellitus. Diabetes Obes Metab 2010;12:323-33
86. Hollander P, Raslova K, Skjøth TV, et al. Efficacy and safety of insulin detemir once daily in combination with sitagliptin and metformin: the TRANSITION randomized controlled trial. Diabetes Obes Metab 2011;13:268-75
87. Kothny W, Foley J, Kozlovski P, et al. Improved glycaemic control with vildagliptin added to insulin, with or without metformin, in patients with type 2 diabetes mellitus. Diabetes Obes Metab 2013;15:252-7
88. Scirica BM, Bhatt DL; SAVOR-TIMI 53 Steering Committee and Investigators. Saxagliptin and cardiovascular outcomes in patients with type 2 diabetes mellitus. N Engl J Med 2013;369:1317-26
89. Seino Y, et al. Rationale, Evaluation of aloGliptin's eFficacy and saFety based on Renal function Study (eGFR Study). Available from: https://upload.umin.ac. jp/cgi-open-bin/ctr/ctr.cgi? function=brows&action= brows&type=summary&recptno= R000007265&language=J [Last accessed 24 May 2012]