Managing hyperglycemia in patients with type 2 diabetes mellitus: Rationale for the use of dipeptidyl peptidase-4 inhibitors in combination with other oral antidiabetic drugs

Journal of the American Osteopathic Association

Volumn 110, Issue 9, 2010, Pages 528-537

  Freeman, Jeffrey S ^a  

^a PHILADELPHIA COLLEGE OF OSTEOPATHIC MEDICINE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ANTIDIABETIC AGENT; DIPEPTIDYL PEPTIDASE IV INHIBITOR;

DRUG COMBINATION; HUMAN; HYPERGLYCEMIA; NON INSULIN DEPENDENT DIABETES MELLITUS; REVIEW; RISK ASSESSMENT;

DIABETES MELLITUS, TYPE 2; DIPEPTIDYL-PEPTIDASE IV INHIBITORS; DRUG THERAPY, COMBINATION; HUMANS; HYPERGLYCEMIA; HYPOGLYCEMIC AGENTS; RISK ASSESSMENT;

EID: 79958265837     PISSN: 00986151     EISSN: 19451997     Source Type: Journal    
DOI: None     Document Type: Review

References (55)

1. Hirsch IB, Brownlee M. Should minimal blood glucose variability become the gold standard of glycemic control [review]? J Diabetes Complications. 2005;19(3):178-181. http://www.mendosa.com/minimal_variability.pdf. Accessed August 25, 2009.
2. The ADVANCE Collaborative Group. Intensive blood glucose control and vascular outcomes in patients with type 2 diabetes. N Engl J Med. 2008;358(24): 2560-2572. http://content.nejm.org/cgi/content/full/358/24/2560. Accessed August 25, 2009.
3. The Action to Control Cardiovascular Risk in Diabetes Study Group. Effects of intensive glucose lowering in type 2 diabetes. N Engl J Med. 2008;358(24): 2545-2559. http://content.nejm.org/cgi/content/full/358/24/2545. Accessed August 25, 2009.
4. Duckworth W, Abraira C, Moritz T, et al. Glucose control and vascular complications in veterans with type 2 diabetes. N Engl J Med. 2009;360(2):129-139. http://content.nejm.org/cgi/content/full/360/2/129. Accessed August 25, 2009.
5. Raz I, Wilson PWF, Strojek K, et al. Effects of prandial versus fasting glycemia on cardiovascular outcomes in type 2 diabetes: the HEART2D trial. Diabetes Care. 2009;32(3):381-386. http://care.diabetesjournals.org/content/32/3/381.long. Accessed August 25, 2009.
6. Holman RR, Paul SK, Bethel MA, Matthews DR, Neil HA. 10-year followup of intensive glucose control in type 2 diabetes. N Engl J Med. 2008;359(15):1577-1589. http://content.nejm.org/cgi/content/full/359/15/1577. Accessed August 25, 2009.
7. The Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications (DCCT/EDIC) Study Research Group. Intensive diabetes treatment and cardiovascular disease in patients with type 1 diabetes. N Engl J Med. 2005;353(25):2643-2653. http://content.nejm.org/cgi/content/full/353/25/2643. Accessed August 25, 2009.
8. Nathan DM, Kuenen J, Borg R, Zheng H, Schoenfeld D, Heine RJ; for the A1c-Derived Average Glucose (ADAG) Study Group. Translating the A1c assay into estimated average glucose values. Diabetes Care. 2008;31(8):1473-1478. http://care.diabetesjournals.org/content/31/8/1473.long. Accessed August 25, 2009.
9. Heine RJ, Balkau B, Ceriello A, Del Prato S, Horton ES, Taskinen MR. What does postprandial hyperglycaemia mean [review]? Diabet Med. 2004;21(3):208-213.
10. Monnier L, Lapinski H, Colette C. Contributions of fasting and postprandial plasma glucose increments to the overall diurnal hyperglycemia of type 2 diabetic patients: variations with increasing levels of HbA1c. Diabetes Care. 2003;26(3):881-885. http://care.diabetesjournals.org/content/26/3/881.long. Accessed August 25, 2009.
11. Bonora E, Corrao G, Bagnardi V, Ceriello A, Comaschi M, Montanari P, et al. Prevalence and correlates of post-prandial hyperglycaemia in a large sample of patients with type 2 diabetes mellitus. Diabetologia. 2006;49(5):846-854. http://www.springerlink.com/content/f348w522264761t5/fulltext.pdf. Accessed August 25, 2009.
12. Woerle HJ, Neumann C, Zschau S, et al. Impact of fasting and postprandial glycemia on overall glycemic control in type 2 diabetes: importance of postprandial glycemia to achieve target HbA1c levels. Diabetes Res Clin ract. 2007;77(2):280-285.
13. 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 [review]. Diabetes Care. 2009;32(1):193-203. http://care.diabetesjournals.org/content/32/1/193.long. Accessed August 25, 2009.
14. Turner RC, Cull CA, Frighi V, Holman RR; for the UK Prospective Diabetes Study (UKPDS) Group. Glycemic control with diet, sulfonylurea, metformin, or insulin in patients with type 2 diabetes mellitus: progressive requirement for multi ple therapies (UKPDS 49). JA M A. 199 9;281 (2 1): 2005 -20 12. http://jama.ama-assn.org/cgi/content/full/281/21/2005. Accessed August 25, 2009.
15. Del Prato S. In search of normoglycaemia in diabetes: controlling postprandial glucose [review]. Int J Obes Relat Metab Disord. 2002;26(suppl 3):S9-S17. http://www.nature.com/ijo/journal/v26/n3s/pdf/0802172a.pdf. Accessed August 25, 2009.
16. Kirpichnikov D, McFarlane SI, Sowers JR. Metformin: an update [review]. Ann Intern Med. 2002;137(1):25-33. http://www.annals.org/cgi/content /full/137/1/25. Accessed August 25, 2009.
17. DeFronzo RA. Pharmacologic therapy for type 2 diabetes mellitus. Ann Intern Med. 1999;131(4):281-303 [review]. http://www.annals.org/cgi/content /full/131/4/281. Accessed August 25, 2009.
18. Barnett A. DPP-4 inhibitors and their potential role in the management of type 2 diabetes [review]. Int J Clin Pract. 2006;60(11):1454-1470. http: //www3.interscience.wiley.com/cgi-bin/fulltext/118555789/PDFSTART. Accessed August 25, 2009.
19. Leiter LA, Ceriello A, Davidson JA, et al; and the International Prandial Glucose Regulation (PGR) Study Group. Postprandial glucose regulation: new data and new implications [review]. Clin Ther. 2005;27(suppl 2):S42-S56.
20. Freeman JS. The pathophysiologic role of incretins [review]. J Am Osteopath Assoc. 2007;107(suppl 3):S6-S9. http://www.jaoa.org/cgi/reprint/107/suppl_3/S6. Accessed August 25, 2009.
21. Göke B, Hershon K, Kerr D, et al. Efficacy and safety of vildagliptin monotherapy during 2-year treatment of drug-naïve patients with type 2 diabetes: comparison with metformin. Horm Metab Res. 2008;40(12):892-895.
22. Qi DS, Teng R, Jiang M, et al. Two-year treatment with sitagliptin and initial combination therapy of sitagliptin and metformin provides substantial and durable glycaemic control in patients with type 2 diabetes. Paper presented at: 44th Annual Meeting of the European Association for the Study of Diabetes; September 7-11, 2008; Rome, Italy. Abstract 73. http://www.easd.org/. Accessed August 25, 2009.
23. DeFronzo RA, Hissa MN, Garber AJ, et al. Once-daily saxagliptin added to metformin provides sustained glycemic control and is well tolerated over 102 weeks in patients with T2D. Paper presented at: 69th Annual Scientific Sessions of the American Diabetes Association; June 5-9, 2009; New Orleans, LA. Abstract 547-P. http://professional.diabetes.org/Abstracts_Display.aspx?TYP=1&CID=73282. Accessed August 25, 2009.
24. DeFronzo RA, Hissa MN, Garber AJ, et al; for the Saxagliptin 014 Study Group. 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(9): June 23 [Epub ahead of print].
25. Charbonnel B, Karasik A, Liu J, Wu M, Meininger G; for the Sitagliptin Study 020 Group. Efficacy and safety of the dipeptidyl peptidase-4 inhibitor sitagliptin added to ongoing metformin therapy in patients with type 2 diabetes inadequately controlled withmetformin alone. Diabetes Care. 2006;29(12):2638-2643. http://care.diabetesjournals.org/content/29/12/2638.long. Accessed August 25, 2009.
26. Raz I, Chen Y, Wu M, et al. Efficacy and safety of sitagliptin added to ongoing metformin therapy in patients with type 2 diabetes. Curr Med Res Opin. 2008;24(2):537-550.
27. Garber AJ, Foley JE, Banerji MA, et al. Effects of vildagliptin on glucose control in patients with type 2 diabetes inadequately controlled with a sulphonylurea. Diabetes Obes Metab. 2008;10(11):1047-1056.
28. Chacra AR, Tan GH, Apanovitch S; for the CV181-040 Investigators. Saxa - gliptin 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(9):1395-1406. http://www3.interscience.wiley.com/cgi-bin /fulltext/122513155/PDFSTART.Accessed August 25, 2009.
29. Pratley RE, Kipnes MS, Fleck PR, Wilson C, Mekki Q; Alogliptin Study 007 Group. Efficacy and safety of the dipeptidyl peptidase-4 inhibitor alogliptin in patients with type 2 diabetes inadequately controlled by glyburide mono - therapy. Diabetes Obes Metab. 2009;11(2):167-176.
30. Allen E, Hollander P, Li J, Chen R. Saxagliptin added to a thiazolidinedione improves glycaemic control in patients with inadequately controlled type 2 diabetes. Poster presented at: 44th Annual Meeting of the European Association for the Study of Diabetes; September 7-11, 2008; Rome, Italy. Poster 859. http://www.easd.org/. Accessed August 25, 2009.
31. Pratley R, Reusch J, Fleck P, Wilson C, Mekki Q. Efficacy and safety of alogliptin added to pioglitazone therapy in patients with type 2 diabetes. Poster presented at: 68th Scientific Sessions of the American Diabetes Association; June 6-10, 2008; San Francisco, CA. Poster 478-P. http://professional.diabetes.org/Abstracts_Display.aspx?TYP=1&CID=69786. Accessed August 25, 2009.
32. Garber AJ, Schweizer A, Baron MA, Rochotte E, Dejager S. Vildagliptin in combination with pioglitazone improves glycaemic control in patients with type 2 diabetes failing thiazolidinedione monotherapy: a randomized, placebo-controlled study. Diabetes Obes Metab. 2007;9(2):166-174. http: //www3.interscience.wiley.com/cgi-bin/fulltext/118491378/PDFSTART. Accessed August 25, 2009.
33. Goldstein BJ, Feinglos MN, Lunceford JK, Johnson J, Williams-Herman DE and the Sitagliptin 036 Study Group. 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(8):1979-1987. http://care.diabetesjournals.org/content/30/8/1979.long. Accessed August 25, 2009.
34. Jadzinsky M, Pfützner A, Paz-Pacheco E, Xu Z, Allen E, Chen R; CV181-039. 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 [published correction appears in Diabetes Obes Metab. 2010; 12(5):462]. Diabetes Obes Metab. 2009;11(6):611-622.
35. Nauck MA, Ellis GC, Fleck PR, Wilson CA, Mekki Q; for the Alogliptin Study 008 Group. Efficacy and safety of adding the dipeptidyl peptidase-4 inhibitor alogliptin to metformin therapy in patients with type 2 diabetes inadequately controlled with metforminmonotherapy: a multicentre, randomised, double-blind, placebo-controlled study. Int J Clin Pract. 2009;63(1):46-55. http://www3.interscience.wiley.com/cgi-bin/fulltext/121569333/PDFSTART. Accessed August 25, 2009.
36. Bosi E, Camisasca RP, Collober C, Rochotte E, Garber AJ. Effects of vildagliptin on glucose control over 24 weeks in patients with type 2 diabetes inadequately controlled with metformin. Diabetes Care. 2007;30(4):890-895. http://care.diabetesjournals.org/content/30/4/890.long. Accessed August 25, 2009.
37. Rosenstock J, Brazg R, Andryuk PJ, Lu K, Stein P; and Sitagliptin Study 019 Group. 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, parallelgroup study. Clin Ther. 2006;28(10):1556-1568.
38. Rosenstock J, Sankoh S, List JF. Glucose-lowering activity of the dipeptidyl peptidase-4 inhibitor saxagliptin in drug-naive patients with type 2 diabetes. Diabetes Obes Metab. 2008;10(5):376-386.
39. DeFronzo RA, Fleck PR, Wilson CA, Mekki Q. 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(12):2315-2317. http://care.diabetesjournals.org/content/31/12/2315.long. Accessed August 25, 2009.
40. Hüttner S, Graefe-Mody EU, Withopf B, Ring A, Dugi KA. Safety, tolerability, pharmacokinetics, and pharmacodynamics of single oral doses of BI 1356, an inhibitor of dipeptidyl peptidase 4, in healthy male volunteers. J Clin Pharmacol. 2008;48(10):1171-1178.
41. Richter B, Bandeira-Echtler E, Bergerhoff K, Lerch CL. Dipeptidyl peptidase- 4 (DPP-4) inhibitors for type 2 diabetes mellitus [review]. Cochrane Database Syst Rev. 2008;(2):CD006739. doi:10.1002/14651858.CD006739.pub2.
42. Aschner P, Kipnes MS, Lunceford JK, Sanchez M, Mickel C, Williams- Herman DE; for the 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(12):2632-2637. http://care.diabetesjournals.org/content/29/12/2632.long. Accessed August 25, 2009.
43. Chen R, Donovan M, Rusnak JM. Saxagliptin used as monotherapy or in combination with other antihyperglycemic agents does not significantly increase risk of hypoglycemia. Abstract presented at: 69th Annual Scientific Sessions of the American Diabetes Association; June 5-9, 2009; New Orleans, LA. Abstract 2082-PO. http://professional.diabetes.org/Abstracts_Display.aspx?TYP=1&CID=74195. Accessed August 25, 2009.
44. Fonseca V, Schweizer A, Albrecht D, Baron MA, Chang I, Dejager S. Addition of vildagliptin to insulin improves glycaemic control in type 2 diabetes. Diabetologia. 2007;50(6):1148-1155. http://www.springerlink.com/content/24361865u731l48n/fulltext.pdf. Accessed August 25, 2009.
45. El-Ouaghlidi A, Rehring E, Holst JJ, et al. The dipeptidyl peptidase 4 inhibitor vildagliptin does not accentuate glibenclamide-induced hypoglycemia but reduces glucose-induced glucagon-like peptide 1 and gastric inhibitory polypeptide secretion. J Clin Endocrinol Metab. 2007;92(11):4165- 4171. http://jcem.endojournals.org/cgi/content/full/92/11/4165. Accessed August 25, 2009.
46. Dalla Man C, Bock G, Giesler PD, et al. Dipeptidyl peptidase-4 inhibition by vildagliptin and the effect on insulin secretion and action in response to meal ingestion in type 2 diabetes. Diabetes Care. 2009;32(1):14-18. http://care.diabetesjournals.org/content/32/1/14.long. Accessed August 25, 2009.
47. Nissen SE, Wolski K. Effect of rosiglitazone on the risk of myocardial infarction and death from cardiovascular causes. N Engl J Med. 2007;356 (24):2457-2471. http://content.nejm.org/cgi/content/full/356/24/2457. Accessed August 25, 2009.
48. Dluhy RG, McMahon GT. Intensive glycemic control in the ACCORD and ADVANCE trials [editorial]. N Engl J Med. 2008;358(24):2630-2633. http://content.nejm.org/cgi/reprint/358/24/2630.pdf. Accessed August 25, 2009.
49. Selvin E, Bolen S, Yeh HC, et al. Cardiovascular outcomes in trials of oral diabetes medications [review]. Arch Intern Med. 2008;168(19):2070-2080. http://archinte.ama-assn.org/cgi/reprint/168/19/2070. Accessed August 25, 2009.
50. US Food and Drug Administration. Guidance for Industry: Diabetes Mellitus- Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes. Silver Spring, MD: US Department of Health and Human Services; 2008.
51. Wolf R, Frederich R, Fiedorek F, et al. Evaluation of CV risk in saxagliptin clinical trials. Poster presented at: 69th Annual Scientific Sessions of the American Diabetes Association; June 5-9, 2009; New Orleans, LA. Poster 8-LB. http://professional.diabetes.org/Abstracts_Display.aspx?TYP=1&CID=74816.
52. Kothny W, Gimpelewicz C, Byiers S, Mills D, Fitchet M. Cardiovascular safety profile of vildagliptin, a new DPP-4 inhibitor for the treatment of type 2 diabetes. Abstract presented at: 44th Annual Meeting of the European Association for the Study of Diabetes; September 7-11, 2008; Rome, Italy. Abstract 915. http://www.easd.org/. Accessed August 25, 2009
53. Williams-Herman DE, Round E, Swern AS, et al. Safety and tolerability of sitagliptin in patients with type 2 diabetes: a pooled analysis. BMC Endocr Disord. 2008;8:14. doi: 10.1186/1472-6823-8-14. http://www.biomedcentral.com/content/pdf/1472-6823-8-14.pdf. Accessed August 25, 2009.
54. Rodbard HW, Jellinger PS, Davidson JA, et al. Statement by an American Association of Clinical Endocrinologists/American College of Endocrinology Consensus Panel on type 2 diabetes mellitus: an algorithm for glycemic control. Endocr Pract. 2009;15(6):541-559.
55. Stratton IM, Adler AI, Neil HA, et al. Association of glycaemia with macrovascular and microvascular complications of type 2 diabetes (UKPDS 35): prospective observational study. BMJ. 2000;321(7258):405-412. http://www.bmj.com/cgi/content/full/321/7258/405?view=long&pmid=10938048. Accessed August 25, 2009.