Tolerability, pharmacokinetics and pharmacodynamics of the once-daily human GLP-1 analog liraglutide in Japanese healthy subjects: A randomized, double-blind, placebo-controlled dose-escalation study

International Journal of Clinical Pharmacology and Therapeutics

Volumn 46, Issue 6, 2008, Pages 273-279

  Irie, S ^a   Matsumura, Y ^b   Zdravkovic, M ^c   Jacobsen, L V ^c   Kageyama, S ^d  

^a Kyushu Clinical Pharmacology Research Clinic   (Japan)

^b Novo Nordisk Pharma Ltd   (Japan)

^c NOVO NORDISK A S   (Denmark)

^d JIKEI UNIVERSITY SCHOOL OF MEDICINE   (Japan)

Author keywords

Dose escalation; GLP 1; Incretin; Japanese subjects; Liraglutide

Indexed keywords

GLUCOSE; HEMOGLOBIN A1C; INSULIN; LIRAGLUTIDE; PLACEBO;

ABNORMAL LABORATORY RESULT; ADULT; AREA UNDER THE CURVE; ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; DRUG BLOOD LEVEL; DRUG CLEARANCE; DRUG DISTRIBUTION; DRUG DOSE ESCALATION; DRUG DOSE TITRATION; DRUG SAFETY; DRUG TOLERABILITY; ECG ABNORMALITY; GASTROINTESTINAL DISEASE; GLUCOSE BLOOD LEVEL; HEMOGLOBIN BLOOD LEVEL; HUMAN; HUMAN EXPERIMENT; HYPOGLYCEMIA; INSULIN BLOOD LEVEL; JAPANESE; MALE; MAXIMUM PLASMA CONCENTRATION; MORNING DOSAGE; NORMAL HUMAN; PHARMACODYNAMICS; RANDOMIZED CONTROLLED TRIAL; TIME TO MAXIMUM PLASMA CONCENTRATION; UNSPECIFIED SIDE EFFECT; WEIGHT REDUCTION;

EID: 45949106901     PISSN: 09461965     EISSN: None     Source Type: Journal    
DOI: 10.5414/CPP46273     Document Type: Article

References (20)

1. Agersø H, Jensen LB, Elbrønd B et al. The pharmacokinetics, pharmacodynamics, safety and tolerability of NN2211, a new long-acting GLP-1 derivative, in healthy men. Diabetologia. 2002; 45: 195-202.
2. Chang AM, Jakobsen G, Sturis J et al. The GLP-1 derivative NN2211 restores β-cell sensitivity to glucose in Type 2 diabetic patients after a single dose. Diabetes. 2003; 52: 1786-1791.
3. DECODA Study Group. Cardiovascular risk profile assessment in Asian glucose-intolerant individuals - an evaluation of the World Health Organization 2-step strategy: the DECODA study. Diabet Med. 2002; 19: 549-557.
4. Degn KB, Juhl CA, Sturis J et al. 1-week treatment with the long-acting GLP-1 derivative, liraglutide (NN2211), markedly improves 24-h glycernia, α- and β-cell function and reduces endogenous glucose release in patients with Type 2 diabetes. Diabetes. 2004; 53: 1187-1194.
5. Elbrønd KB, Jakobsen G, Larsen S et al. Pharmacokinetics, pharmacodynamics, safety and tolerability of a single dose of NN2211, a long-acting glucagon-like peptide 1 derivative, in healthy mate subjects. Diabetes Care. 2002; 25: 1398-1404.
6. Feinglos MN, Saad MF, Pi-Sunyer FX et al. Effects of liraglutide (NN2211), a long-acting GLP- 1 analogue, on glycemic control and body weight in subjects with Type 2 diabetes. Diabet Med. 2005; 22: 1016-1023.
7. Fukushima M, Sukuki H, Seino Y. Insulin secretion capacity in the development from normal glucose tolerance to Type 2 diabetes. Diab Res Clin Pract. 2004; 66S: S37-S43.
8. Juhl CB, Hollingdal M, Sturis J et al. Bedtime administration of NN2211, a long-acting GLP-1 derivative, substantially reduces fasting and postprandial glycemia in Type 2 diabetes. Diabetes. 2002; 51: 424-429.
9. Kageyama S, Hirao K, Shimizu A et al. Tolerability, pharmacokinetics and pharmacodynamics of liraglutide, long-acting human GLP- 1 analogue - Phase I studies in Japanese healthy subjects and subjects with Type 2 diabetes. Endocrinol Diab. 2007; 24: 95-104.
10. Kendall DM, Riddle MA, Rosenstock J et al. Effects of exenatide (exendin-4) on glycemic control over 30 weeks in patients with Type 2 diabetes treated with metformin and a sulfonylurea. Diabetes Care. 2005, 28: 1083-1091.
11. Madsbad S, Schmitz O, Ranstam J et al. 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.
12. Mari A, Degn K, Brock B et al. Effects of the long-acting human GLP- 1 analogue liraglutide on β-cell function in normal living conditions. Diabetes Care. 2007; 30: 2032-2033.
13. Meier JJ, Gallwitz B, Nauck MA. Glucagon-like peptide and gastric inhibitory polypeptide: potential applications in Type 2 diabetes mellitus. BioDrugs. 2003; 17: 93-102.
14. Nauck Ma, Meier JJ, Creutzfeldt W. Incretins and their analogues as new antidiabetic agents. Drug News Perspect. 2003; 16:413-422.
15. Nauck MA, Hompesch M, Filipczak R et al. Five weeks of treatment with the GLP- 1 analogue liraglutide improves glycemic control and lowers body weight in subjects with Type 2 diabetes. Exp Clin Endocrinol Diab. 2006; 114:417-423.
16. Seino Y, Kaku K, Nishijima K et al. Once-daily dosing of the long acting GLP-1 analogue liraglutide significantly improves glycemic control by reducing both fasting and post-prandial glucose levels in Japanese subjects with Type 2 diabetes. Diabetes. 2007; 56 (Suppl. 1): A138 (0520-P).
17. Stumvoll M, Goldstein BJ, van Haeften TW. Type2 diabetes: principles of pathogenesis and therapy. Lancet. 2005; 365: 1333-1346.
18. Sturis J, Gotfredsen CF, Romer J et al. GLP- 1 derivative liraglutide in rats with β-cell deficiencies. Influence of metabolic state on β-cell mass dynamics. Br J Pharmacol. 2003; 140: 123-132.
19. Vilsbøll T, Zdravkovic M, Le-Thi T et al. Liraglutide, a long-acting human GLP- 1 analog, given as monotherapy significantly improves glycemic control and lowers body weight without risk of hypoglycemia in patients with Type 2 diabetes. Diabetes Care. 2007; 30: 1608-1610.
20. Wilken M, Larsen FS, Juul AG et al. An immunoassay for the GLP- 1 derivative NN2211. Diabetologia. 2000; 43 (Suppl 1): 143.