Lack of pharmacokinetic interaction between dapagliflozin, a novel sodium-glucose transporter 2 inhibitor, and metformin, pioglitazone, glimepiride or sitagliptin in healthy subjects

Diabetes, Obesity and Metabolism

Volumn 13, Issue 1, 2011, Pages 47-54

  Kasichayanula, S ^a   Liu, X ^a   Shyu, W C ^a,b   Zhang, W ^a   Pfister, M ^a   Griffen, S C ^a   Li, T ^a   LaCreta, F P ^a   Boulton, D W ^a  

^a BRISTOL MYERS SQUIBB   (United States)

^b MILLENNIUM PHARMACEUTICALS INC   (United States)

Author keywords

Antidiabetic drug; Clinical trial; Pharmacokinetics; SGLT2 inhibitor; Type 2 diabetes

Indexed keywords

DAPAGLIFLOZIN; GLIMEPIRIDE; METFORMIN; PIOGLITAZONE; SITAGLIPTIN;

ADULT; ANXIETY; AREA UNDER THE CURVE; ARTICLE; BLOOD SAMPLING; CLINICAL TRIAL; CONTROLLED STUDY; CROSSOVER PROCEDURE; DRUG BLOOD LEVEL; DRUG SAFETY; DRUG TOLERABILITY; FATIGUE; FEMALE; GEOMETRY; HEADACHE; HUMAN; HUMAN EXPERIMENT; HYPOGLYCEMIA; MALE; MONOTHERAPY; NAUSEA; NORMAL HUMAN; OPEN STUDY; PHARMACODYNAMICS; SIDE EFFECT; SINGLE DRUG DOSE;

EID: 78649715079     PISSN: 14628902     EISSN: 14631326     Source Type: Journal    
DOI: 10.1111/j.1463-1326.2010.01314.x     Document Type: Article

References (24)

1. Nathan DM, Buse JB, Davidson MB, et al. 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 2009; 32: 193-203.
2. Turner RC, Cull CA, Frighi V, Holman RR. 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: 2005-2012.
3. Han S, Hagan DL, Taylor JR, et al. Dapagliflozin, a selective SGLT2 inhibitor, improves glucose homeostasis in normal and diabetic rats. Diabetes 2008; 57: 1723-1729.
4. Meng W, Ellsworth BA, Nirschl AA, et al. Discovery of dapagliflozin: a potent, selective renal sodium-dependent glucose cotransporter 2 (SGLT2) inhibitor for the treatment of type 2 diabetes. J Med Chem 2008; 51: 1145-1149.
5. Wright EM, Hirayama BA, Loo DF. Active sugar transport in health and disease. J Intern Med 2007; 261: 32-43.
6. Komoroski B, Vachharajani N, Boulton D, et al. Dapagliflozin, a novel SGLT2 inhibitor, induces dose-dependent glucosuria in healthy subjects. Clin Pharmacol Ther 2009; 85: 520-526.
7. Komoroski B, Vachharajani N, Feng Y, Li L, Kornhauser D, Pfister M. Dapagliflozin, a novel, selective SGLT2 inhibitor, improved glycemic control over 2 weeks in patients with type 2 diabetes mellitus. Clin Pharmacol Ther 2009; 85: 513-519.
8. List JF, Woo V, Morales E, Tang W, Fiedorek FT. Sodium-glucose cotransport inhibition with dapagliflozin in type 2 diabetes. Diabetes Care 2009; 32: 650-657.
9. Wilding JPH, Norwood P, T'joen C, Bastien A, List JF, Fiedorek FT. A study of dapagliflozin in patients with type 2 diabetes receiving high doses of insulin plus insulin sensitizers. Applicability of a novel insulin-independent treatment. Diabetes Care 2009; 32: 1656-1662.
10. Goodarzi MO, Bryer-Ash M. Metformin revisited: re-evaluation of its properties and role in the pharmacopoeia of modern antidiabetic agents. Diabetes Obes Metab 2005; 7: 654-665.
11. Hundal RS, Inzucchi SE. Metformin: new understandings, new uses. Drugs 2003; 63: 1879-1894.
12. Yki-Jarvinen H. Thiazolidinediones. N Engl J Med 2004; 351: 1106-1118.
13. Korytkowski MT. Sulfonylurea treatment of type 2 diabetes mellitus: focus on glimepiride. Pharmacotherapy 2004; 24: 606-620.
14. Ahren B. Emerging dipeptidyl peptidase-4 inhibitors for the treatment of diabetes. Expert Opin Emerg Drugs 2008; 13: 593-607.
15. Bergman A, Mistry GC, Luo WL, et al. Dose-proportionality of a final market image sitagliptin formulation, an oral dipeptidyl peptidase-4 inhibitor, in healthy volunteers. Biopharm Drug Dispos 2007; 28: 307-313.
16. Di Cicco RA, Allen A, Carr A, Fowles S, Jorkasky DK, Freed MI. Rosiglitazone does not alter the pharmacokinetics of metformin. J Clin Pharmacol 2000; 40: 1280-1285.
17. He YL, Sabo R, Picard F, et al. Study of the pharmacokinetic interaction of vildagliptin and metformin in patients with type 2 diabetes. Curr Med Res Opin 2009; 25: 1265-1272.
18. Migoya EM, Stevens CH, Bergman AJ, et al. Effect of moderate hepatic insufficiency on the pharmacokinetics of sitagliptin. Can J Clin Pharmacol 2009; 16: e165-e170.
19. Niemi M, Kivisto KT, Backman JT, Neuvonen PJ. Effect of rifampicin on the pharmacokinetics and pharmacodynamics of glimepiride. Br J Clin Pharmacol 2000; 50: 591-595.
20. Januvia [prescribing information]. Whitehouse Station, NJ: Merck & Co. Available from URL: Accessed 9 March 2010.
21. Glucophage [prescribing information]. Princeton, NJ: Bristol-Myers Squibb Company. Available from URL: Accessed 16 February 2010.
22. Actos [prescribing information]. Deerfield, IL: Takeda Pharmaceuticals America, Inc. Available from URL: Accessed 9 March 2010.
23. Amaryl [prescribing information]. Bridgewater, NJ: sanofi-aventis US LLC. Available from URL: Accessed 9 March 2010.
24. Bailey CJ, Gross JL, Pieters A, Bastien A, List JF. Effect of dapagliflozin in patients with type 2 diabetes who have inadequate glycaemic control with metformin: a randomised, double-blind, placebo-controlled trial. Lancet 2010; 375: 2223-2233.