Sitagliptin for Type 2 diabetes: a 2015 update

References

• Unger RH, Orci L. The essential role of glucagon in the pathogenesis of diabetes mellitus. Lancet 1975;1(7897):14-16
   PubMed Web of Science ®Google Scholar
• Centers for Disease Control and Prevention. National Diabetes Statistics Report: Estimates of Diabetes and Its Burden in the United States, 2014. Atlanta, GA: US Department of Health and Human Services; 2014
   Google Scholar
• The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. The Diabetes Control and Complications Trial Research Group. N Engl J Med 1993;329(14):977-86
   PubMed Web of Science ®Google Scholar
• Writing Team for the Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications Research Group. Effect of intensive therapy on the microvascular complications of type 1 diabetes mellitus. JAMA 2002;287(19):2563-9
   PubMed Web of Science ®Google Scholar
• 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(9131):837-53
   PubMed Web of Science ®Google Scholar
• Holman RR, Paul SK, Bethel MA, et al. 10-year follow-up of intensive glucose control in type 2 diabetes. N Engl J Med 2008;359(15):1577-89
   PubMed Web of Science ®Google Scholar
• Masharani U, German M. Pancreatic Hormones and Diabetes Mellitus ( eds. D., G, D., S McGraw Hill; 2011
   Google Scholar
• Drucker DJ. The biology of incretin hormones. Cell Metab 2006;3(3):153-65
   PubMed Web of Science ®Google Scholar
• Lund A, Bagger JI, Christensen M, et al. Glucagon and type 2 diabetes: the return of the alpha cell. Curr Diab Rep 2014;14(12):555
   PubMed Web of Science ®Google Scholar
• Ban K, Noyan-Ashraf MH, Hoefer J, et al. Cardioprotective and vasodilatory actions of glucagon-like peptide 1 receptor are mediated through both glucagon-like peptide 1 receptor-dependent and -independent pathways. Circulation 2008;117(18):2340-50
   PubMed Web of Science ®Google Scholar
• Davidson MH. Cardiovascular effects of glucagon like peptide-1 agonists. Am J Cardiol 2011;108(3 Suppl):33B-41B
   Web of Science ®Google Scholar
• Food and Drug Administration. FDA News Release: FDA Approves New Treatment for Diabetes. 2006
   Google Scholar
• Sitagliptin (Januvia) US prescribing information. 2006
   Google Scholar
• Zhang H, Chen Y, Keane FM, Gorrell MD. Advances in understanding the expression and function of dipeptidyl peptidase 8 and 9. Mol Cancer Res 2013;11(12):1487-96
   PubMed Web of Science ®Google Scholar
• Bergman AJ, Stevens C, Zhou Y, et al. Pharmacokinetic and pharmacodynamic properties of multiple oral doses of sitagliptin, a dipeptidyl peptidase-IV inhibitor: a double-blind, randomized, placebo-controlled study in healthy male volunteers. Clin Ther 2006;28(1):55-72
   PubMed Web of Science ®Google Scholar
• 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(11):4612-19
   PubMed Web of Science ®Google Scholar
• Scheen AJ. Pharmacokinetics of dipeptidylpeptidase-4 inhibitors. Diabetes Obes Metab 2010;12(8):648-58
   PubMed Web of Science ®Google Scholar
• Aschner P, Kipnes MS, Lunceford JK, et al. Effect of the dipeptidyl peptidase-4 inhibitor sitagliptin as monotherapy on glycemic control in patients with type 2 diabetes. Diabetes Care 2006;29(12):2632-7
   PubMed Web of Science ®Google Scholar
• 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(11):2564-71
   PubMed Web of Science ®Google Scholar
• 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(12):2638-43
   PubMed Web of Science ®Google Scholar
• Kadowaki T, Tajima N, Odawara M, et al. Addition of sitagliptin to ongoing metformin monotherapy improves glycemic control in Japanese patients with type 2 diabetes over 52 weeks. J Diabetes Investig 2013;4(2):174-81
   PubMed Web of Science ®Google Scholar
• 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(10):1556-68
   PubMed Web of Science ®Google Scholar
• 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(2):167-77
   PubMed Web of Science ®Google Scholar
• 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(2):194-205
   PubMed Web of Science ®Google Scholar
• Liu SC, Chien KL, Wang CH, et al. Efficacy and safety of adding pioglitazone or sitagliptin to patients with type 2 diabetes insufficiently controlled with metformin and a sulfonylurea. Endocr Pract 2013;19(6):980-8
   PubMed Web of Science ®Google Scholar
• Lavalle-Gonzalez FJ, Januszewicz A, Davidson J, et al. Efficacy and safety of canagliflozin compared with placebo and sitagliptin in patients with type 2 diabetes on background metformin monotherapy: a randomised trial. Diabetologia 2013;56(12):2582-92
   PubMed Web of Science ®Google Scholar
• Schernthaner G, Gross JL, Rosenstock J, et al. Canagliflozin compared with sitagliptin for patients with type 2 diabetes who do not have adequate glycemic control with metformin plus sulfonylurea: a 52-week randomized trial. Diabetes Care 2013;36(9):2508-15
   PubMed Web of Science ®Google Scholar
• Ferrannini E, Berk A, Hantel S, et al. Long-term safety and efficacy of empagliflozin, sitagliptin, and metformin: an active-controlled, parallel-group, randomized, 78-week open-label extension study in patients with type 2 diabetes. Diabetes Care 2013;36(12):4015-21
   PubMed Web of Science ®Google Scholar
• Li CJ, Liu XJ, Bai L, et al. Efficacy and safety of vildagliptin, Saxagliptin or Sitagliptin as add-on therapy in Chinese patients with type 2 diabetes inadequately controlled with dual combination of traditional oral hypoglycemic agents. Diabetol Metab Syndr 2014;6:69
   PubMed Web of Science ®Google Scholar
• Yokoyama H, Hirao K, Yamaguchi K, et al. Liraglutide Versus Sitagliptin in a 24-week, Multicenter, Open-label, Randomized, Parallel-group Study in Japanese Type 2 Diabetes Mellitus Patients Responding Inadequately to a Sulfonylurea and/or One or Two Other Oral Antidiabetic Drugs (JDDM 33). Jpn Clin Med 2014;5:33-41
   PubMedGoogle Scholar
• Charbonnel B, Steinberg H, Eymard E, et al. Efficacy and safety over 26 weeks of an oral treatment strategy including sitagliptin compared with an injectable treatment strategy with liraglutide in patients with type 2 diabetes mellitus inadequately controlled on metformin: a randomised clinical trial. Diabetologia 2013;56(7):1503-11
   PubMed Web of Science ®Google Scholar
• Aschner P, Chan J, Owens DR, et al. Insulin glargine versus sitagliptin in insulin-naive patients with type 2 diabetes mellitus uncontrolled on metformin (EASIE): a multicentre, randomised open-label trial. Lancet 2012;379(9833):2262-9
   PubMed Web of Science ®Google Scholar
• Katsuno T, Ikeda H, Ida K, et al. Add-on therapy with the DPP-4 inhibitor sitagliptin improves glycemic control in insulin-treated Japanese patients with type 2 diabetes mellitus. Endocr J 2013;60(6):733-42
   PubMed Web of Science ®Google Scholar
• Williams-Herman D, Engel SS, Round E, et al. Safety and tolerability of sitagliptin in clinical studies: a pooled analysis of data from 10,246 patients with type 2 diabetes. BMC Endocr Disord 2010;10:7
   PubMed Web of Science ®Google Scholar
• Food and Drug Administration. Information for Healthcare Professionals - Acute pancreatitis and sitagliptin (marketed as Januvia and Janumet). 2009
   Google Scholar
• Singh S, Chang HY, Richards TM, et al. Glucagonlike peptide 1-based therapies and risk of hospitalization for acute pancreatitis in type 2 diabetes mellitus: a population-based matched case-control study. JAMA Intern Med 2013;173(7):534-9
   PubMed Web of Science ®Google Scholar
• Li L, Shen J, Bala MM, et al. Incretin treatment and risk of pancreatitis in patients with type 2 diabetes mellitus: systematic review and meta-analysis of randomised and non-randomised studies. BMJ 2014;348:g2366
   PubMed Web of Science ®Google Scholar
• Sudhakaran C, Kishore U, Anjana RM, et al. Effectiveness of sitagliptin in Asian Indian patients with type 2 diabetes-an Indian tertiary diabetes care center experience. Diabetes Technol Ther 2011;13(1):27-32
   PubMed Web of Science ®Google Scholar
• 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(11):2349-54
   PubMed Web of Science ®Google Scholar
• Egan AG, Blind E, Dunder K, et al. Pancreatic safety of incretin-based drugs--FDA and EMA assessment. N Engl J Med 2014;370(9):794-7
   PubMed Web of Science ®Google Scholar
• Reinhold D, Biton A, Goihl A, et al. Dual inhibition of dipeptidyl peptidase IV and aminopeptidase N suppresses inflammatory immune responses. Ann N Y Acad Sci 2007;1110:402-9
   PubMed Web of Science ®Google Scholar
• Tremblay AJ, Lamarche B, Deacon CF, et al. Effects of sitagliptin therapy on markers of low-grade inflammation and cell adhesion molecules in patients with type 2 diabetes. Metabolism 2014;63(9):1141-8
   PubMed Web of Science ®Google Scholar
• Matsubara J, Sugiyama S, Akiyama E, et al. Dipeptidyl peptidase-4 inhibitor, sitagliptin, improves endothelial dysfunction in association with its anti-inflammatory effects in patients with coronary artery disease and uncontrolled diabetes. Circ J 2013;77(5):1337-44
   PubMed Web of Science ®Google Scholar
• Eurich DT, Simpson S, Senthilselvan A, et al. Comparative safety and effectiveness of sitagliptin in patients with type 2 diabetes: retrospective population based cohort study. BMJ 2013;346:f2267
   PubMed Web of Science ®Google Scholar
• Engel SS, Golm GT, Shapiro D, et al. Cardiovascular safety of sitagliptin in patients with type 2 diabetes mellitus: a pooled analysis. Cardiovasc Diabetol 2013;12:3
   PubMed Web of Science ®Google Scholar
• Leibovitz E, Gottlieb S, Goldenberg I, et al. Sitagliptin pretreatment in diabetes patients presenting with acute coronary syndrome: results from the Acute Coronary Syndrome Israeli Survey (ACSIS). Cardiovasc Diabetol 2013;12:53
   PubMed Web of Science ®Google Scholar
• Ishikawa S, Shimano M, Watarai M, et al. Impact of sitagliptin on carotid intima-media thickness in patients with coronary artery disease and impaired glucose tolerance or mild diabetes mellitus. Am J Cardiol 2014;114(3):384-8
   PubMed Web of Science ®Google Scholar
• Oyama J, Ishizu T, Sato Y, et al. Rationale and design of a study to evaluate the effects of sitagliptin on atherosclerosis in patients with diabetes mellitus: PROLOGUE study. Int J Cardiol 2014;174(2):383-4
   PubMed Web of Science ®Google Scholar
• Chen DY, Wang SH, Mao CT, et al. Sitagliptin and cardiovascular outcomes in diabetic patients with chronic kidney disease and acute myocardial infarction: A nationwide cohort study. Int J Cardiol 2014;181C:200-6
   Google Scholar
• Wang KL, Liu CJ, Chao TF, et al. Sitagliptin and the risk of hospitalization for heart failure: a population-based study. Int J Cardiol 2014;177(1):86-90
   PubMed Web of Science ®Google Scholar
• Scirica BM, Bhatt DL, Braunwald E, et al. Saxagliptin and cardiovascular outcomes in patients with type 2 diabetes mellitus. N Engl J Med 2013;369(14):1317-26
   PubMed Web of Science ®Google Scholar
• Green JB, Bethel MA, Paul SK, et al. Rationale, design, and organization of a randomized, controlled Trial Evaluating Cardiovascular Outcomes with Sitagliptin (TECOS) in patients with type 2 diabetes and established cardiovascular disease. Am Heart J 2013;166(6):983-9 e7
   PubMed Web of Science ®Google Scholar
• Nozue T, Fukui K, Koyama Y, et al. Effects of sitagliptin on coronary atherosclerosis evaluated using integrated backscatter intravascular ultrasound in patients with type 2 diabetes: rationale and design of the TRUST study. Heart Vessels 2015. [ Epub ahead of print]
   Google Scholar
• Arjona Ferreira JC, Marre M, Barzilai N, et al. Efficacy and safety of sitagliptin versus glipizide in patients with type 2 diabetes and moderate-to-severe chronic renal insufficiency. Diabetes Care 2013;36(5):1067-73
   PubMed Web of Science ®Google Scholar
• Arjona Ferreira JC, Corry D, Mogensen CE, et al. Efficacy and safety of sitagliptin in patients with type 2 diabetes and ESRD receiving dialysis: a 54-week randomized trial. Am J Kid Dis 2013;61(4):579-87
   PubMed Web of Science ®Google Scholar
• Arase Y, Kawamura Y, Seko Y, et al. Efficacy and safety in sitagliptin therapy for diabetes complicated by non-alcoholic fatty liver disease. Hepatol Res 2013;43(11):1163-8
   PubMed Web of Science ®Google Scholar
• Umpierrez GE, Gianchandani R, Smiley D, et al. Safety and efficacy of sitagliptin therapy for the inpatient management of general medicine and surgery patients with type 2 diabetes: a pilot, randomized, controlled study. Diabetes Care 2013;36(11):3430-5
   PubMed Web of Science ®Google Scholar
• Round EM, Engel SS, Golm GT, et al. Safety of sitagliptin in elderly patients with type 2 diabetes: a pooled analysis of 25 clinical studies. Drugs Aging 2014;31(3):203-14
   PubMed Web of Science ®Google Scholar
• Chen TY, Hsieh CJ. Real-world effectiveness of sitagliptin as add-on therapy in patients with type 2 diabetes mellitus. Postgrad Med 2014;126(3):205-15
   PubMed Web of Science ®Google Scholar
• Montilla S, Marchesini G, Sammarco A, et al. Drug utilization, safety, and effectiveness of exenatide, sitagliptin, and vildagliptin for type 2 diabetes in the real world: data from the Italian AIFA Anti-diabetics Monitoring Registry. Nutr Metab Cardiovasc Dis 2014;24(12):1346-53
   PubMed Web of Science ®Google Scholar
• Esposito K, Chiodini P, Maiorino MI, et al. Glycaemic durability with dipeptidyl peptidase-4 inhibitors in type 2 diabetes: a systematic review and meta-analysis of long-term randomised controlled trials. BMJ Open 2014;4(6):e005442
   PubMed Web of Science ®Google Scholar
• 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(5):562-76
   PubMed Web of Science ®Google Scholar
• 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(5):442-51
   PubMed Web of Science ®Google Scholar
• Migoya EM, Miller JL, Gutierrez M, et al. Bioequivalence of sitagliptin/metformin fixed-dose combination tablets and concomitant administration of sitagliptin and metformin in healthy adult subjects: a randomized, open-label, crossover study. Clin Drug Investig 2010;30(12):855-66
   PubMed Web of Science ®Google Scholar
• Ahren B. Use of DPP-4 inhibitors in type 2 diabetes: focus on sitagliptin. Diabetes Metab Syndr Obes 2010;3:31-41
   PubMedGoogle Scholar
• Zerilli T, Pyon EY. Sitagliptin phosphate: a DPP-4 inhibitor for the treatment of type 2 diabetes mellitus. Clin Ther 2007;29(12):2614-34
   PubMed Web of Science ®Google Scholar
• Mohan V, Yang W, Son HY, et al. Efficacy and safety of sitagliptin in the treatment of patients with type 2 diabetes in China, India, and Korea. Diabetes Res Clin Pract 2009;83(1):106-16
   PubMed Web of Science ®Google Scholar
• Nonaka K, Kakikawa T, Sato A, et al. Efficacy and safety of sitagliptin monotherapy in Japanese patients with type 2 diabetes. Diabetes Res Clin Pract 2008;79(2):291-8
   PubMed Web of Science ®Google Scholar