Use of the dipeptidyl peptidase-4 inhibitor linagliptin in combination therapy for type 2 diabetes

Bibliography

• Baggio LL, Drucker DJ. Biology of incretins: GLP-1 and GIP. Gastroenterology 2007;132:2131-57
   PubMed Web of Science ®Google Scholar
• Gromada J, Holst JJ, Rorsman P. Cellular regulation of islet hormone secretion by the incretin hormone glucagon-like peptide 1. Pflugers Arch 1998;435:583-94
   PubMed Web of Science ®Google Scholar
• Reimann F. Molecular mechanisms underlying nutrient detection by incretin-secreting cells. Int Dairy J 2010;20:236-42
   PubMed Web of Science ®Google Scholar
• Hsieh J, Longuet C, Baker CL, The glucagon-like peptide 1 receptor is essential for postprandial lipoprotein synthesis and secretion in hamsters and mice. Diabetologia 2010;53:552-61
   PubMed Web of Science ®Google Scholar
• Ayala JE, Bracy DP, James FD, The glucagon-like peptide-1 receptor regulates endogenous glucose production and muscle glucose uptake independent of its incretin action. Endocrinology 2009;150:1155-64
   PubMed Web of Science ®Google Scholar
• Sangle G, Lauffer L, Grieco A, Novel Biological Action of the Dipeptidylpeptidase 4 Inhibitor, Sitagliptin, as a GLP-1 Secretagogue. Presented at the American Diabetes Association 71st Scientific Sessions; 24 – 28 June 2011; San Diego, CA; 2011
   Google Scholar
• Muscelli E, Casolaro A, Gastaldelli A. Mechanisms of the Antihyperglycemic Effect of Sitagliptin in Patients with Type 2 Diabetes (T2D). Presented at the American Diabetes Association 71st Scientific Sessions; 24 – 28 June 2011; San Diego, CA; 2011
   Google Scholar
• Heise T, Graefe-Mody EU, Huttner S, Pharmacokinetics, pharmacodynamics and tolerability of multiple oral doses of linagliptin, a dipeptidyl peptidase-4 inhibitor in male type 2 diabetes patients. Diabetes Obes Metab 2009;11:786-94
   PubMed Web of Science ®Google Scholar
• Sarashina A, Sesoko S, Nakashima M, Linagliptin, a dipeptidyl peptidase-4 inhibitor in development for the treatment of type 2 diabetes mellitus: a Phase I, randomized, double-blind, placebo-controlled trial of single and multiple escalating doses in healthy adult male Japanese subjects. Clin Ther 2010;32:1188-204
   PubMed Web of Science ®Google Scholar
• Neumiller JJ, Campbell RK. Saxagliptin: a dipeptidyl peptidase-4 inhibitor for the treatment of type 2 diabetes mellitus. Am J Health Syst Pharm 2010;67:1515-25
   PubMed Web of Science ®Google Scholar
• Deacon CF, Holst JJ. Saxagliptin: a new dipeptidyl peptidase-4 inhibitor for the treatment of type 2 diabetes. Adv Ther 2009;26:488-99
   PubMed Web of Science ®Google Scholar
• Thornberry NA, Weber AE. Discovery of JANUVIA (Sitagliptin), a selective dipeptidyl peptidase IV inhibitor for the treatment of type 2 diabetes. Curr Top Med Chem 2007;7:557-68
   PubMed Web of Science ®Google Scholar
• Herman GA, Bergman A, Liu F, Pharmacokinetics and pharmacodynamic effects of the oral DPP-4 inhibitor sitagliptin in middle-aged obese subjects. J Clin Pharmacol 2006;46:876-86
   PubMed Web of Science ®Google Scholar
• Herman GA, Stevens C, Van Dyck K, Pharmacokinetics and pharmacodynamics of sitagliptin, an inhibitor of dipeptidyl peptidase IV, in healthy subjects: results from two randomized, double-blind, placebo-controlled studies with single oral doses. Clin Pharmacol Ther 2005;78:675-88
   PubMed Web of Science ®Google Scholar
• Gallwitz B. Saxagliptin, a dipeptidyl peptidase IV inhibitor for the treatment of type 2 diabetes. IDrugs 2008;11:906-17
   PubMed Web of Science ®Google Scholar
• Thomas L, Eckhardt M, Langkopf E, (R)-8-(3-amino-piperidin-1-yl)-7-but-2-ynyl-3-methyl-1-(4-methyl-quinazoli n-2-ylmethyl)-3,7-dihydro-purine-2,6-dione (BI 1356), a novel xanthine-based dipeptidyl peptidase 4 inhibitor, has a superior potency and longer duration of action compared with other dipeptidyl peptidase-4 inhibitors. J Pharmacol Exp Ther 2008;325:175-82
   PubMed Web of Science ®Google Scholar
• Tradjenta [package insert]. Ridgefield, CT: Boehringer Ingelheim Pharmaceuticals, Inc. 2011. Available from: http://www.tradjenta.com [Accessed 25 July 2012]; Tradjenta [package insert]. Ridgefield, CT: Boehringer Ingelheim Pharmaceuticals, Inc. 2011. Available from: http://www.tradjenta.com/TRADJENTA_(TM)_(linagliptin)_tablets_Prescribing_Information_including_Patient_Information.pdf [Accessed 3 May 2011]
   Google Scholar
• Turner RC, Cull CA, Frighi V, 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
   PubMed Web of Science ®Google Scholar
• Cook MN, Girman CJ, Stein PP, Initial monotherapy with either metformin or sulphonylureas often fails to achieve or maintain current glycaemic goals in patients with Type 2 diabetes in UK primary care. Diabet Med 2007;24:350-8
   PubMed Web of Science ®Google Scholar
• Karter AJ, Moffet HH, Liu J, Glycemic response to newly initiated diabetes therapies. Am J Manag Care 2007;13:598-606
   PubMed Web of Science ®Google Scholar
• Handelsman Y, Mechanick JI, Blonde L, American Association of Clinical Endocrinologists Medical Guidelines for clinical practice for developing a diabetes mellitus comprehensive care plan: executive summary. Endocr Pract 2011;17:287-302
   PubMed Web of Science ®Google Scholar
• Handelsman Y, Mechanick JI, Blonde L, American Association of Clinical Endocrinologists Medical Guidelines for Clinical Practice for developing a diabetes mellitus comprehensive care plan. Endocr Pract 2011;17(Suppl 2):1-53
   PubMed Web of Science ®Google Scholar
• Rodbard HW, Jellinger PS, Davidson JA, 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;15:540-59
   PubMed Web of Science ®Google Scholar
• Del Prato S, Barnett AH, Huisman H, 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
   PubMed Web of Science ®Google Scholar
• Owens DR, Swallow R, Dugi KA, 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
   PubMed Web of Science ®Google Scholar
• Taskinen MR, Rosenstock J, Tamminen I, 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
   PubMed Web of Science ®Google Scholar
• Schernthaner G, Barnett AH, Emser A, Safety and tolerability of linagliptin: a pooled analysis of data from randomized controlled trials in 3572 patients with type 2 diabetes mellitus. Diabetes Obes Metab 2012;14:470-8
   PubMed Web of Science ®Google Scholar
• Forst T, Uhlig-Laske B, Ring A, 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
   PubMed Web of Science ®Google Scholar
• Haak T, Meinicke T, Jones R, Initial combination of linagliptin and metformin improves glycaemic control in type 2 diabetes: a randomized, double-blind, placebo-controlled study. Diabetes Obes Metab 2012;14:565-74
   PubMed Web of Science ®Google Scholar
• Jentadueto [package insert]. Boehringer Ingelheim Pharmaceuticals, Inc. Ridgefield, CT 06877 USA. 2012. Available from: http://www.accessdata.fda.gov. [Accessed 31 January 2012]
   Google Scholar
• Lewin AJ, Arvay L, Liu D, Efficacy and tolerability of linagliptin added to a sulfonylurea regimen in patients with inadequately controlled type 2 diabetes mellitus: an 18-week, multicenter, randomized, double-blind, placebo-controlled trial. Clin Ther 2012;34:1909-19. e15
   PubMed Web of Science ®Google Scholar
• Gomis R, Espadero RM, Jones R, 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
   PubMed Web of Science ®Google Scholar
• Gomis R, Owens DR, Taskinen MR, Long-term safety and efficacy of linagliptin as monotherapy or in combination with other oral glucose-lowering agents in 2121 subjects with type 2 diabetes: up to 2 years exposure in 24-week phase III trials followed by a 78-week open-label extension. Int J Clin Pract 2012;66:731-40
   PubMed Web of Science ®Google Scholar
• Rendell M, Chrysant SG, Emser A, Linagliptin Effectively Reduces HbA1c Independent of Age in Patients With Type 2 Diabetes. Presented at The Endocrine Society 93rd Annual Meeting; 4 – 7 June 2011; Boston, MA; 2011
   Google Scholar
• Barnett AH, Huisman H, Jones H, Efficacy and safety of linagliptin in elderly patients (≥ 70 Years) with Type 2 Diabetes. Poster: 1017-P, presented at the American Diabetes Association 72nd Scientific Sessions; 8 – 12 June 2012; Philadelphia, PA; 2012
   Google Scholar
• Von Eynatten M, Neubacher D, Patel S, Safety and Efficacy of Linagliptin in Combination With Basal Insulin: A Pre-Specified, Pooled Analysis in a Vulnerable Population of Elderly Patients (Age ≥ 70 Years) With Type 2 Diabetes. Presented at The Endocrine Society (ENDO) 94th Annual Meeting & Expo; 23 – 26 June 2012; Houston, TX; 2012
   Google Scholar
• Abe M, Okada K, Soma M. Antidiabetic agents in patients with chronic kidney disease and end-stage renal disease on dialysis: metabolism and clinical practice. Curr Drug Metab 2011;12:57-69
   PubMed Web of Science ®Google Scholar
• Graefe-Mody U, Friedrich C, Port A, Effect of renal impairment on the pharmacokinetics of the dipeptidyl peptidase-4 inhibitor linagliptin(*). Diabetes Obes Metab 2011;13:939-46
   PubMed Web of Science ®Google Scholar
• Cooper M, Von Eynatten M, Emser A, Efficacy and Safety of Linagliptin in Patients With Type 2 Diabetes With or Without Renal Function Decline: Results From a Global Phase 3 Program Poster: 1068-P, presented at the 71st Scientific Sessions of the American Diabetes Association; 24 – 28 June 2011; San Diego, CA; 2011
   Google Scholar
• Sloan L, Newman J, Sauce C, Safety and Efficacy of Linagliptin in Type 2 Diabetes Patients With Severe Renal Impairment Abstract number: 413–PP, presented at the American Diabetes Association 71st Scientific Sessions; 24 – 28 June 2011; San Diego, CA; 2011
   Google Scholar
• McGill JB, Sloan L, Newman J, Long-term efficacy and safety of linagliptin in patients with type 2 diabetes and severe renal impairment: a 1-year, randomized, double-blind, placebo-controlled study. Diabetes Care 2012; Epub ahead of print
   PubMed Web of Science ®Google Scholar
• Meyers JL, Candrilli SD, Kovacs B. Type 2 diabetes mellitus and renal impairment in a large outpatient electronic medical records database: rates of diagnosis and antihyperglycemic medication dose adjustment. Postgrad Med 2011;123:133-43
   PubMed Web of Science ®Google Scholar
• Johansen OE, Neubacher D, von Eynatten M, Cardiovascular safety with linagliptin in patients with type 2 diabetes mellitus: a pre-specified, prospective, and adjudicated meta-analysis of a phase 3 programme. Cardiovasc Diabetol 2012;11:3
   PubMed Web of Science ®Google Scholar
• Gallwitz B, Rosenstock J, Rauch T, 2-year efficacy and safety of linagliptin compared with glimepiride in patients with type 2 diabetes inadequately controlled on metformin: a randomised, double-blind, non-inferiority trial. Lancet 2012;380:475-83
   PubMed Web of Science ®Google Scholar
• CAROLINA (Cardiovascular Outcome Study of Linagliptin versus Glimepiride in Patients with Type 2 Diabetes). Available at: http://clinicaltrials.gov. Accessed September 18, 2012
   Google Scholar
• Peyrot M, Peeples M, Tomky D, Development of the American Association of Diabetes Educators' Diabetes Self-management Assessment Report Tool. Diabetes Educ 2007;33:818-26
   PubMed Web of Science ®Google Scholar
• Inzucchi SE, Bergenstal RM, Buse JB, 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
   PubMed Web of Science ®Google Scholar
• Bonds DE, Miller ME, Bergenstal RM, The association between symptomatic, severe hypoglycaemia and mortality in type 2 diabetes: retrospective epidemiological analysis of the ACCORD study. BMJ 2010;340:b4909
   PubMed Web of Science ®Google Scholar
• D'Ancona G, Bertuzzi F, Sacchi L, Iatrogenic hypoglycemia secondary to tight glucose control is an independent determinant for mortality and cardiac morbidity. Eur J Cardiothorac Surg 2011;40:360-6
   PubMed Web of Science ®Google Scholar
• Krinsley JS, Schultz MJ, Spronk PE, Mild hypoglycemia is independently associated with increased mortality in the critically ill. Crit Care 2011;15:R173
   PubMed Web of Science ®Google Scholar
• Wright RJ, Frier BM. Vascular disease and diabetes: is hypoglycaemia an aggravating factor? Diabetes Metab Res Rev 2008;24:353-63
   PubMed Web of Science ®Google Scholar
• Yakubovich N, Gerstein HC. Serious cardiovascular outcomes in diabetes: the role of hypoglycemia. Circulation 2011;123:342-8
   PubMed Web of Science ®Google Scholar
• Zoungas S, Patel A, Chalmers J, Severe hypoglycemia and risks of vascular events and death. N Engl J Med 2010;363:1410-18
   PubMed Web of Science ®Google Scholar
• Zhang W, Xing SS, Wang HJ, Fixed-dose single tablet combinations: an alternative for initial therapy of patients with type 2 diabetes? Curr Med Res Opin 2011;27:2321-2
   PubMed Web of Science ®Google Scholar
• Barlow S, Crean J, Heizler A, Diabetes educators: assessment of evolving practice. Diabetes Educ 2005;31:359-72
   PubMed Web of Science ®Google Scholar
• Riddle MC. Is initial combination therapy effective in the treatment of type 2 diabetes? Nat Clin Pract Endocrinol Metab 2006;2:254-5
   PubMedGoogle Scholar
• Olansky L, Reasner C, Seck TL, A treatment strategy implementing combination therapy with sitagliptin and metformin results in superior glycaemic control versus metformin monotherapy due to a low rate of addition of antihyperglycaemic agents. Diabetes Obes Metab 2011;13:841-9
   PubMed Web of Science ®Google Scholar
• Reasner C, Olansky L, Seck TL, The effect of initial therapy with the fixed-dose combination of sitagliptin and metformin compared with metformin monotherapy in patients with type 2 diabetes mellitus. Diabetes Obes Metab 2011;13:644-52
   PubMed Web of Science ®Google Scholar
• Wainstein J, Katz L, Engel SS, Initial therapy with the fixed-dose combination of sitagliptin and metformin results in greater improvement in glycaemic control compared with pioglitazone monotherapy in patients with type 2 diabetes. Diabetes Obes Metab 2011;14:409-18
   PubMed Web of Science ®Google Scholar
• Yoon KH, Shockey GR, Teng R, 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
   PubMed Web of Science ®Google Scholar
• Goldstein BJ, Feinglos MN, Lunceford JK, 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
   PubMed Web of Science ®Google Scholar
• Jadzinsky M, Pfützner A, Paz-Pacheco E, 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
   PubMed Web of Science ®Google Scholar
• Rosenstock J, Inzucchi SE, Seufert J, Initial combination therapy with alogliptin and pioglitazone in drug-naive patients with type 2 diabetes. Diabetes Care 2010;33:2406-8
   PubMed Web of Science ®Google Scholar
• Williams-Herman D, Johnson J, Teng R, 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
   PubMed Web of Science ®Google Scholar
• Rosenstock J, Kim SW, Baron MA, Efficacy and tolerability of initial combination therapy with vildagliptin and pioglitazone compared with component monotherapy in patients with type 2 diabetes. Diabetes Obes Metab 2007;9:175-85
   PubMed Web of Science ®Google Scholar
• Fu AZ, Qiu Y, Davies MJ, Treatment intensification in patients with type 2 diabetes who failed metformin monotherapy. Diabetes Obes Metab 2011;13:765-9
   PubMed Web of Science ®Google Scholar