Dosing rationale for liraglutide in type 2 diabetes mellitus: A pharmacometric assessment

Journal of Clinical Pharmacology

Volumn 52, Issue 12, 2012, Pages 1815-1823

  Ingwersen, Steen H ^a   Khurana, Manoj ^b   Madabushi, Rajanikanth ^b   Watson, Estelle ^a   Jonker, Daniël M ^a   Le Thi, Tu Duyen ^a   Jacobsen, Lisbeth V ^a   Tornøe, Christoffer W ^a  

^a NOVO NORDISK A S   (Denmark)

^b CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

Author keywords

calcitonin; GLP 1; HbA1c; Pharmacometrics; regulatory approval

Indexed keywords

ANTIDIABETIC AGENT; GLIMEPIRIDE; GLUCAGON LIKE PEPTIDE 1 RECEPTOR AGONIST; GLUCOSE; HEMOGLOBIN A1C; LIRAGLUTIDE; METFORMIN; PLACEBO;

ADJUVANT THERAPY; ADULT; AGED; ARTICLE; BODY WEIGHT; CLINICAL PHARMACOLOGY; CONTROLLED CLINICAL TRIAL (TOPIC); DIET; DOSE RESPONSE; DRUG APPROVAL; DRUG BLOOD LEVEL; DRUG CLEARANCE; DRUG DOSE COMPARISON; DRUG EFFECT; DRUG EFFICACY; ENZYME LINKED IMMUNOSORBENT ASSAY; ETHNICITY; EXERCISE; FEMALE; FOOD AND DRUG ADMINISTRATION; GLUCOSE BLOOD LEVEL; GLYCEMIC CONTROL; HUMAN; MALE; MONOTHERAPY; NON INSULIN DEPENDENT DIABETES MELLITUS; PHARMACOMETRICS; RANDOMIZED CONTROLLED TRIAL (TOPIC); RISK BENEFIT ANALYSIS; SEX DIFFERENCE; STATISTICAL ANALYSIS; TREATMENT OUTCOME;

ADOLESCENT; ADULT; AGED; AGED, 80 AND OVER; BLOOD GLUCOSE; CALCITONIN; DIABETES MELLITUS, TYPE 2; DOSE-RESPONSE RELATIONSHIP, DRUG; FASTING; FEMALE; GLUCAGON-LIKE PEPTIDE 1; HEMOGLOBIN A, GLYCOSYLATED; HUMANS; HYPOGLYCEMIC AGENTS; MALE; MIDDLE AGED; YOUNG ADULT;

EID: 84868625533     PISSN: 00912700     EISSN: 15524604     Source Type: Journal    
DOI: 10.1177/0091270011430504     Document Type: Article

References (22)

1. US Food and Drug Administration. FDA labeling information-Victoza (liraglutide). http://www.accessdata.fda.gov/drugsatfda-docs/label/2010/ 022341s001lbl.pdf. Accessed June 27, 2011.
2. Knudsen LB, Nielsen PF, Huusfeldt PO, et al. Potent derivatives of glucagon-like peptide-1 with pharmacokinetic properties suitable for once daily administration. J Med Chem. 2000 ; 43: 1664-1669
3. Sjöholm Å. Liraglutide therapy for type 2 diabetes: overcoming unmet needs. Pharmaceuticals. 2010 ; 3: 764-781
4. Parks M, Rosebraugh C. Weighing risks and benefits of liraglutide-the FDA's review of a new antidiabetic therapy. N Engl J Med. 2010 ; 362: 774-776
5. Clinical pharmacology review(s). http://www.accessdata.fda.gov/ drugsatfda-docs/nda/2010/022341s000clinpharmr.pdf. Accessed June 27, 2011.
6. Madsbad S, Schmitz O, Ranstam J, Jakobsen G, Matthews DR. Improved glycemic control with no weight increase in patients with type 2 diabetes after once-daily treatment with the long-acting glucagon-like peptide 1 analog liraglutide (NN2211): a 12-week, double-blind, randomized, controlled trial. Diabetes Care. 2004 ; 27: 1335-1342
7. Vilsboll T, Brock B, Perrild H, et al. Liraglutide, a once-daily human GLP-1 analogue improves beta-cell function and arginine stimulated insulin secretion at hyperglycaemia in patients with type 2 diabetes. Diabetes Med. 2008 ; 25: 152-156
8. Garber A, Henry R, Garcia-Hernandez PA, et al. Liraglutide versus glimepiride monotherapy for type 2 diabetes (LEAD-3 Mono): a randomised, 52 week, phase III, double-blind, parallel-treatment trial. Lancet. 2009 ; 373: 473-481
9. Garber A, Henry RR, Ratner R, et al. Liraglutide, a once-daily human GLP-1 analogue, provides sustained improvements in glycaemic control and weight for two years as monotherapy compared with glimepiride in patients with type 2 diabetes. Diabetes Obes Metab. 2011 ; 13: 346-58
10. WMA General Assembly. WMA Declaration of Helsinki-Ethical Principles for Medical Research Involving Human Subjects. http://www.wma.net/en/30publications/ 10policies/b3/index.html. Accessed June 27, 2011.
11. Agersø H, Jensen LB, Elbrønd B, Rolan P, Zdravkovic M. The pharmacokinetics, pharmacodynamics, safety and tolerability of NN2211, a new long-acting GLP-1 derivative, in healthy men. Diabetologia. 2002 ; 45: 195-202
12. Marre M, Shaw J, Brandle M, et al. Liraglutide, a once-daily human GLP-1 analogue, added to a sulphonylurea over 26 weeks produces greater improvements in glycaemic and weight control compared with adding rosiglitazone or placebo in subjects with type 2 diabetes (LEAD-1 SU). Diabetes Med. 2009 ; 26: 268-278
13. Nauck MA, Frid A, Hermansen K, et al. Efficacy and safety comparison of liraglutide, glimepiride, and placebo, all in combination with metformin in type 2 diabetes. Diabetes Care. 2009 ; 32: 84-90
14. Zinman B, Gerich J, Buse J, et al. Efficacy and safety of the human GLP-1 analog liraglutide in combination with metformin and TZD in patients with type 2 diabetes mellitus (LEAD-4 Met+TZD). Diabetes Care. 2009 ; 32: 1224-1230
15. Russell-Jones D, Vaag A, Schmitz O, et al. Liraglutide vs insulin glargine and placebo in combination with metformin and sulphonylurea therapy in type 2 diabetes mellitus: a randomised controlled trial (LEAD-5 met+SU). Diabetologia. 2009 ; 52: 2046-2055
16. Gallwitz B, Vaag A, Falahati A, Madsbad S. Adding liraglutide to oral antidiabetic drug therapy: onset of treatment effects over time. Int J Clin Pract. 2010 ; 64: 267-276
17. Standards of medical care in diabetes-2011. Diabetes Care. 2011 ; 34: S11 - S61
18. Damholt B, Golor G, Wierich W, Pedersen P, Ekblom M, Zdravkovic M. An open-label, parallel group study investigating the effects of age and gender on the pharmacokinetics of the once-daily glucagon-like peptide-1 analogue liraglutide. J Clin Pharmacol. 2006 ; 46: 635-641
19. Statistical review(s). http://www.accessdata.fda.gov/drugsatfda-docs/nda/ 2010/022341s000statr.pdf. Accessed June 27, 2011.
20. Lee L. US FDA Office of Generic Drugs' Pharmaceutical Quality Initiative: progress and feedback on question-based review. Pharm Eng. 2007 ; 27: 52-60
21. Bhattaram AV, Bonapace C, Chilukuri DM, et al. Impact of pharmacometric review on new drug approvals and labeling decisions-a survey of 31 new drug applications submitted between 2005 and 2006. Clin Pharmacol Ther. 2007 ; 81: 213-221
22. Garnett C, Lee JY, Gobburu JV Clinical Trial Simulations: Applications and Trends. Kimko HC Peck CC, ed. New York, NY: Springer Verlag ; 37-57.