Linagliptin for type 2 diabetes mellitus: A review of the pivotal clinical trials

Therapeutic Advances in Endocrinology and Metabolism

Volumn 3, Issue 4, 2012, Pages 113-124

  Mcgill, Janet B ^a  

^a WASHINGTON UNIVERSITY SCHOOL OF MEDICINE   (United States)

Author keywords

DPP 4 inhibitor; linagliptin; oral antidiabetic drug; Tradjenta; Trajenta; type 2 diabetes

Indexed keywords

2,4 THIAZOLIDINEDIONE DERIVATIVE; DIPEPTIDYL PEPTIDASE IV; DIPEPTIDYL PEPTIDASE IV INHIBITOR; GLIMEPIRIDE; GLUCOSE; GLYCOSYLATED HEMOGLOBIN; LINAGLIPTIN; METFORMIN; ORAL ANTIDIABETIC AGENT; PIOGLITAZONE; PLACEBO; SULFONYLUREA;

ADD ON THERAPY; ARTICLE; BLOOD GLUCOSE MONITORING; CLINICAL TRIAL (TOPIC); COUGHING; DIABETES CONTROL; DIABETIC PATIENT; DRUG APPROVAL; DRUG EFFICACY; DRUG EXCRETION; DRUG MECHANISM; DRUG SAFETY; DRUG TOLERABILITY; ENTEROHEPATIC CIRCULATION; ENZYME INHIBITION; FOOD AND DRUG ADMINISTRATION; GLUCOSE BLOOD LEVEL; HUMAN; HYPERGLYCEMIA; HYPERLIPIDEMIA; HYPOGLYCEMIA; KIDNEY DISEASE; LIVER DISEASE; MONOTHERAPY; NON INSULIN DEPENDENT DIABETES MELLITUS; PRIORITY JOURNAL; RHINOPHARYNGITIS; SIDE EFFECT; WEIGHT GAIN;

EID: 84864721471     PISSN: 20420188     EISSN: 20420196     Source Type: Journal    
DOI: 10.1177/2042018812449406     Document Type: Article

References (25)

1. American Diabetes Association (2011) Standards of medical care in diabetes - 2011. Diabetes Care 34(Suppl. 1): S11–S61.
2. Blech S. Ludwig-Schwellinger E. Graefe-Mody E.U. Withopf B. Wagner K. (2010) The metabolism and disposition of the oral dipeptidyl peptidase-4 inhibitor, linagliptin, in humans. Drug Metab Dispos 38: 667–678.
3. Boehringer Ingelheim Pharmaceuticals Inc. (2010) CAROLINA, Cardiovascular outcome study of linagliptin versus glimepiride in patients with type 2 diabetes. Available at: http://clinicaltrials.gov/ct2/show/NCT01243424?term=BI1356&recr=Open&rank=5.
4. Boehringer Ingelheim Pharmaceuticals Inc. (2011) Tradjenta (linagliptin) prescribing information. Available at: http://bidocs.boehringer-ingelheim.com/BIWebAccess/ViewServlet.ser?docBase=renetnt&folderPath=/Prescribing+Information/PIs/Tradjenta/Tradjenta.pdf.
5. Del Prato S. Barnett A.H. Huisman H. Neubacher D. Woerle H.J. Dugi K.A. (2011) 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 13: 258–267.
6. Forst T. Uhlig-Laske B. Ring A. Graefe-Mody U. Friedrich C. Herbach K. et al. (2010) 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 27: 1409–1419.
7. Gallwitz B. Uhlig-Laske B. Battacharaya S. Patel S. Woerle H.-J. (2011) Linagliptin has similar efficacy to glimepiride but improved cardiovascular safety over 2 years in patients with type 2 diabetes inadequately controlled on metformin (Poster 39-LB). In: Proceedings of the 71st Annual Scientific Session of the American Diabetes Association (ADA), Vol. 60 (Suppl. 1), 24–28 June 2011, San Diego, CA.
8. Gomis R. Espadero R.M. Jones R. Woerle H.J. Dugi K.A. (2011) 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 13: 653–661.
9. Graefe-Mody E.U. Jungnik A. Ring A. Woerle H.J. Dugi K.A. (2010) Evaluation of the pharmacokinetic interaction between the dipeptidyl peptidase-4 inhibitor linagliptin and pioglitazone in healthy volunteers. Int J Clin Pharmacol Ther 48: 652–661.
10. Graefe-Mody U. Rose P. Ring A. Zander K. Iovino M. Woerle H.J. (2011) Assessment of the pharmacokinetic interaction between the novel DPP-4 inhibitor linagliptin and a sulfonylurea, glyburide, in healthy subjects. Drug Metab Pharmacokinet 26: 123–129.
11. Heise T. Graefe-Mody E.U. Huttner S. Ring A. Trommeshauser D. Dugi K.A. (2009) Pharmacokinetics, pharmacodynamics and tolerability of multiple oral doses of linagliptin, a dipeptidyl peptidase-4 inhibitor in male type 2 diabetes patients. Diabetes Obes Metab 11: 786–794.
12. Johansen O.-E. Neubacher D. Von Eynatten M. Patel S. Woerle H.-J. (2011) Cardiovascular risk with linagliptin in patients with type 2 diabetes: a pre-specified, prospective, and adjudicated meta-analysis from a large phase III program (Abstract 0030-LB). In: Proceedings of the 71st Annual Scientific Session of the American Diabetes Association (ADA), Vol. 60 (Suppl. 1), 24–28 June 2011, San Diego, CA.
13. Must A. Spadano J. Coakley E.H. Field A.E. Colditz G. Dietz W.H. (1999) The disease burden associated with overweight and obesity. JAMA 282: 1523–1529.
14. Nathan D.M. Buse J.B. Davidson M.B. Ferrannini E. Holman R.R. Sherwin R. et al. (2009) 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. Diabetes Care 32: 193–203.
15. Owens D.R. Swallow R. Dugi K.A. Woerle H.J. (2011) 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 28: 1352–1361.
16. Phung O.J. Scholle J.M. Talwar M. Coleman C.I. (2010) Effect of noninsulin antidiabetic drugs added to metformin therapy on glycemic control, weight gain, and hypoglycemia in type 2 diabetes. JAMA 303: 1410–1418.
17. Richter B. Bandeira-Echtler E. Bergerhoff K. Lerch C. (2008) Emerging role of dipeptidyl peptidase-4 inhibitors in the management of type 2 diabetes. Vasc Health Risk Manag 4: 753–768.
18. Rosenstock J. Marx N. Kahn S.E. Zinman B. Kastelein J.J. Lachin J.M. et al. (2011) Rationale and design of the CAROLINA trial: An active comparator CARdiOvascular outcome study of the DPP-4 inhibitor LINAgliptin in patients with type 2 diabetes at high cardiovascular risk (Abstract 1103-P). In: Proceedings of the 71st Annual Scientific Session of the American Diabetes Association (ADA), Vol. 60 (Suppl. 1), 24–28 June 2011, San Diego, CA.
19. Scheen A.J. (2011) Linagliptin for the treatment of type 2 diabetes (pharmacokinetic evaluation). Expert Opin Drug Metab Toxicol 7: 1561–1576.
20. Sloan L. Newman J. Sauce C. von Eynatten M. Patel S. Woerle H.-J. (2011) Safety and efficacy of linagliptin in type 2 diabetes patients with severe renal impairment. In: Proceedings of the 71st Annual Scientific Session of the American Diabetes Association (ADA), Vol. 60 (Suppl. 1), 24–28 June 2011, San Diego, CA.
21. Taskinen M.R. Rosenstock J. Tamminen I. Kubiak R. Patel S. Dugi K.A. et al. (2011) 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 13: 65–74.
22. Toth P.P. (2011) Linagliptin: a new DPP-4 inhibitor for the treatment of type 2 diabetes mellitus. Postgrad Med 123: 46–53.
23. US Food and Drug Administration (2008) Guidance for Industry. Diabetes Mellitus: Developing Drugs and Therapeutic Biologics for Treatment and Prevention. DRAFT GUIDANCE. Available at: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm071624.pdf.
24. Willemen M.J. Mantel-Teeuwisse A.K. Straus S.M. Meyboom R.H. Egberts T.C. Leufkens H.G. (2011) Use of dipeptidyl peptidase-4 inhibitors and the reporting of infections: a disproportionality analysis in the World Health Organization VigiBase. Diabetes Care 34: 369–374.
25. Workgroup on Hypoglycemia and American Diabetes Association (2005) Defining and reporting hypoglycemia in diabetes: a report from the American Diabetes Association Workgroup on Hypoglycemia. Diabetes Care 28: 1245–1249.