Efficacy and safety of linagliptin (Tradjenta) in adults with type-2 diabetes mellitus

P and T

Volumn 36, Issue 12, 2011, Pages

  Freeman, Maisha Kelly ^a  

^a SAMFORD UNIVERSITY   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

GLIBENCLAMIDE; GLIMEPIRIDE; LINAGLIPTIN; METFORMIN; MOXIFLOXACIN; PIOGLITAZONE; PLACEBO; RIFAMPICIN; SAXAGLIPTIN; SITAGLIPTIN; SULFONYLUREA;

ADULT DISEASE; ARTICLE; BACKACHE; DRUG DOSE ESCALATION; DRUG EFFICACY; DRUG INDUCED HEADACHE; DRUG SAFETY; DRUG STRUCTURE; ENZYME BINDING; HUMAN; HYPERGLYCEMIA; HYPERSENSITIVITY; HYPERTENSION; HYPOGLYCEMIA; KIDNEY DISEASE; LIVER DISEASE; MONOTHERAPY; MYALGIA; NON INSULIN DEPENDENT DIABETES MELLITUS; SIDE EFFECT; SINGLE DRUG DOSE; TREATMENT INDICATION; WEIGHT GAIN;

EID: 83755173502     PISSN: 10521372     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (33)

1. 2011 National Diabetes Fact Sheet. Available at: www.cdc.gov/diabetes/pubs/factsheet11.htm. Accessed July 2, 2011.
2. Kim S. Burden of hospitalizations primarily due to uncontrolled diabetes: Implications of inadequate primary health care in the United States. Diabetes Care 2007; 30:1281-1282.
3. Executive summary: Standards of medical care in diabetes, 2011. Diabetes Care 2011;34(Suppl 1):S11-S61.
4. Turner RC, Cull CA, Frighi V, Holman RR. Glycemic control with diet, sulfonyl urea, metformin, or insulin in patients with type-2 diabetes mellitus: Progressive requirement for multiple therapies (UKPDS 49). JAMA 1999;281:2005-2012.
5. FDA. FDA approves new treatment for type-2 diabetes, May 2, 2011. Available at: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm253501.htm. Accessed August 15, 2011.
6. Tradjenta (linagliptin), package insert. Ridgefield, Conn.: Boehringer Ingelheim; July 2011. Available at: http://bidocs.boehringer-ingelheim.com. Accessed July 1, 2011.
7. Onglyza (saxagliptin), package insert. Princeton, N.J.: Bristol-Myers Squibb; February 2011. Available at: http://packageinserts.bms.com/pi/pi_onglyza.pdf. Accessed May 31, 2011.
8. Januvia (sitagliptin), package insert. Whitehouse Station, N.J.: Merck; April 2011. Available at: www.merck.com/product/usa/pi_circulars/j/januvia/januvia_pi.pdf. Accessed May 31, 2011.
9. Gerich J. DPP-4 inhibitors: What may be the clinical dif ferentiators? Diabetes Res Clin Pract 2010;90:131-140.
10. Heise T, Graefe-Mody EU, Huttner S, et al. Pharmacokinetics, pharmaco - dynamics and tolerability of multiple oral doses of linagliptin, a dipeptidyl peptidase- 4 inhibitor, in male type-2 diabetes patients. Diabetes Obesity Metab 2009;11: 786-794.
11. Thomas L, Eckhardt M, Langkopf E, et al. (R)-8-(3-amino-piperidin-1-yl)-7-but- 2-ynyl-3-methyl-1-(4-methyl-quinazolin-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;325:175-182.
12. Deacon CF, Holst JJ. Linagliptin, a xanthine- based dipeptidyl peptidase-4 inhibitor with an unusual profile for the treatment of type-2 diabetes. Exp Opin Invest Drugs 2010;19:133-140.
13. Retlich S, Duval V, Ring A, et al. Pharmacokinetics and pharmacodynamics of single rising intravenous doses (0.5 mg-10 mg) and determination of absolute bioavailability of dipeptidyl peptidase-4 inhibitor linagliptin (BI 1356) in healthy male subjects. Clin Pharmacokinet 2010; 49:829-840.
14. Blech S, Ludwig-Schwellinger E, Grafe-Mody EU, et al. The metabolism and disposition of oral dipeptidyl peptidase-4 inhibitor, linagliptin, in humans. Drug Metab Dispos 2010;38:667-678.
15. Retlich R, Duval V, Graefe-Mody U, et al. Impact of target-mediated drug disposition on linagliptin pharmacokinetics and DPP-4 inhibition in type-2 diabetic patients. J Clin Pharmacol 2010;50:873-885.
16. Hüttner S, Graefe-Mody EU, Withopf B, et al. Safety, tolerability, pharmaco kinetics, and pharmacodynamics of single oral doses of B1 1356, an inhibitor of dipeptidyl peptidase 4, in healthy male volunteers. J Clin Pharmacol 2008;48: 1171-1178.
17. Sarashina A, Sesoko S, Nakashima M, et al. Linagliptin, a dipeptidyl peptidase-4 inhibitor in development for the treatment of type-2 diabetes mellitus: A phase I, randomized, double-blind, placebocontrolled trial of single and multiple escalating doses in healthy adult male Japanese subjects. Clin Ther 2010;32: 1188-1204.
18. Fura A, Khanna A, Vyas V, et al. Pharmacokinetics of the dipeptidyl peptidase 4 inhibitor saxagliptin in rats, dogs, and monkeys and clinical projections. Drug Metab Dispos 2009;37:1164-1171.
19. 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 in - adequately controlled type-2 diabetes: A randomized controlled trial. Diabetes Obesity Metab 2011;13:258-267.
20. Rendell M, Chrysant SG. Review of the safety and efficacy of linagliptin as add-on therapy to metformin in patients with type-2 diabetes: A randomized, doubleblind, placebo-controlled study. Postgraded 2011;123:183-186.
21. Forst T, Uhlig-Laske B, Ring A, et al. Linagliptin (BI 1256), a potent and selective DPP-4 inhibitor, is safe and efficacious in combination with metformin in patients with inadequately controlled type-2 diabetes. Diabetic Med 2010;27: 1409-1419.
22. Taskinen MR, Rosenstock J, Tamminen I, et al. Safety and efficacy of lina gliptin as add-on therapy to metformin in patients with type-2 diabetes: A randomized, double-blind, placebo-controlled study. Diabetes Obesity Metab 2011;13:65-74.
23. 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, doubleblind, placebo-controlled study. Diabetes Obesity Metab 2011;13:653-661.
24. Ring A, Port A, Graefe-Mody EU, et al. The DPP-4 inhibitor linagliptin does not prolong the QT interval at therapeutic and supratherapeutic doses. Br J Clin Pharmacol 2011;72:39-50.
25. Graefe-Mody U, Friedrich C, Port A, et al. Effect of renal impairment on the pharmacokinetics of the dipeptidyl pepti - dase-4 inhibitor linagliptin. Diabetes Obesity Metab 2011;13(10):939-946.
26. Drug interactions between glipizide XL and linagliptin. Available at: www.drugs.com/drug-interactions/glipizide-xl-withlinagliptin-1179-3473-3322-0.html. Accessed October 12, 2011.
27. Graefe-Mody U, Rose P, Ring A, et al. Assessment of the pharmacokinetic interaction between the novel DPP-4 inhibitor linagliptin and a sulfonylurea, glyburide, in healthy subjects. Drug Metab Pharmacokinet 2011;26:123-129.
28. Scheen AJ. Dipeptidylpeptidase-4 inhibitors (gliptins): Focus on drug-drug interactions. Clin Pharmacokinet 2010;49: 573-588.
29. Graefe-Mody EU, Padula S, Ring A, et al. Evaluation of the potential for steady-state pharmacokinetic and pharmacodynamic interactions between the DPP-4 inhibitor linagliptin and metformin in healthy subjects. Curr Med Res Opin 2009;25:1963-1972.
30. Graefe-Mody EU, Brand T, Ring A, et al. continued from page 812 Effect of linagliptin on the pharmaco - kinetics and pharmacodynamics of warfarin in healthy volunteers. Int J Clin Pharmacol Ther 2011;49:300-310.
31. Friedrich C, Ring A, Brand T, et al. Evaluation of the pharmacokinetic interaction after multiple oral doses of linagliptin and digoxin in healthy volunteers. Eur J Drug Metab Pharmacokinet 2011;36:17-24.
32. Graefe-Mody U, Huettner S, Stähle H, et al. Effect of linagliptin (BI 1356) on the steady-state pharmacokinetics of simvastatin. Int J Clin Pharmacol Ther 2010; 48:367-374.
33. Red Book Online via Micromedex. Available at: www.thomsonhc.com and www.redbook.com. Accessed July 2, 2011.