Pharmacokinetics, Pharmacodynamics, and Safety of Luseogliflozin in Japanese Patients with Type 2 Diabetes Mellitus: A Randomized, Single-blind, Placebo-controlled Trial

Advances in Therapy

Volumn 32, Issue 4, 2015, Pages 319-340

  Sasaki, Takashi ^a   Seino, Yutaka ^b   Fukatsu, Atsushi ^c   Ubukata, Michito ^d   Sakai, Soichi ^d   Samukawa, Yoshishige ^d  

^a JIKEI UNIVERSITY SCHOOL OF MEDICINE   (Japan)

^b KANSAI ELECTRIC POWER CO   (Japan)

^c Yachiyo Hospital   (Japan)

^d TAISHO PHARMACEUTICAL CO LTD   (Japan)

Author keywords

Luseogliflozin; Pharmacodynamics; Sodium glucose cotransporter 2 (SGLT2); Type 2 diabetes mellitus; Urinary glucose excretion

Indexed keywords

1,5-ANHYDRO-1-(5-(4-ETHOXYBENZYL)-2-METHOXY-4-METHYLPHENYL)-1-THIOGLUCITOL; ANTIDIABETIC AGENT; GLUCOSE BLOOD LEVEL; SODIUM GLUCOSE COTRANSPORTER 2; SORBITOL;

ADULT; AGED; ANALOGS AND DERIVATIVES; ANTAGONISTS AND INHIBITORS; ASIAN CONTINENTAL ANCESTRY GROUP; CONTROLLED STUDY; DIABETES MELLITUS, TYPE 2; DOSE RESPONSE; FEMALE; GLUCOSE BLOOD LEVEL; HUMAN; JAPAN; MALE; MIDDLE AGED; RANDOMIZED CONTROLLED TRIAL; SINGLE BLIND PROCEDURE;

ADULT; AGED; ASIAN CONTINENTAL ANCESTRY GROUP; BLOOD GLUCOSE; DIABETES MELLITUS, TYPE 2; DOSE-RESPONSE RELATIONSHIP, DRUG; FEMALE; HUMANS; HYPOGLYCEMIC AGENTS; JAPAN; MALE; MIDDLE AGED; SINGLE-BLIND METHOD; SODIUM-GLUCOSE TRANSPORTER 2; SORBITOL;

EID: 84936928820     PISSN: 0741238X     EISSN: 18658652     Source Type: Journal    
DOI: 10.1007/s12325-015-0200-x     Document Type: Article

References (19)

1. Ghosh RK, Ghosh SM, Chawla S, Jasdanwala SA. SGLT2 inhibitors: a new emerging therapeutic class in the treatment of type 2 diabetes mellitus. J Clin Pharmacol. 2012;52(4):457–63.
2. Harada N, Inagaki N. Role of sodium-glucose transporters in glucose uptake of the intestine and kidney. J Diabetes Investig. 2012;3(4):352–3.
3. Bays H. Sodium glucose co-transporter type 2 (SGLT2) inhibitors: targeting the kidney to improve glycemic control in diabetes mellitus. Diabetes Ther. 2013;4(2):195–220.
4. Kurosaki E, Ogasawara H. Ipragliflozin and other sodium-glucose cotransporter-2 (SGLT2) inhibitors in the treatment of type 2 diabetes: preclinical and clinical data. Pharmacol Ther. 2013;139(1):51–9.
5. Tahrani AA, Barnett AH, Bailey CJ. SGLT inhibitors in management of diabetes. Lancet Diabetes Endocrinol. 2013;1(2):140–51.
6. Kakinuma H, Oi T, Hashimoto-Tsuchiya Y, et al. (1S)-1,5-anhydro-1-[5-(4-ethoxybenzyl)-2-methoxy-4-methylphenyl]-1-thio-d-glucitol (TS-071) is a potent, selective sodium-dependent glucose cotransporter 2 (SGLT2) inhibitor for type 2 diabetes treatment. J Med Chem. 2010;53(8):3247–61.
7. Yamamoto K, Uchida S, Kitano K, et al. TS-071 is a novel, potent and selective renal sodium-glucose cotransporter 2 (SGLT2) inhibitor with anti-hyperglycaemic activity. Br J Pharmacol. 2011;164(1):181–91.
8. Sasaki T, Seino Y, Fukatsu A, Sakai S, Samukawa Y. Safety, pharmacokinetics, and pharmacodynamics of single and multiple luseogliflozin dosing in healthy Japanese males: a randomized, single-blind, placebo-controlled trial. Adv Ther. 2014;31(3):345–61.
9. Seino Y, Sasaki T, Fukatsu A, Sakai S, Samukawa Y. Efficacy and safety of luseogliflozin monotherapy in Japanese patients with type 2 diabetes mellitus: a 12-week, randomized, placebo-controlled, phase II study. Curr Med Res Opin. 2014;30(7):1219–30.
10. Seino Y, Sasaki T, Fukatsu A, Ubukata M, Sakai S, Samukawa Y. Dose-finding study of luseogliflozin in Japanese patients with type 2 diabetes mellitus: a 12-week, randomized, double-blind, placebo-controlled, phase II study. Curr Med Res Opin. 2014;30(7):1231–44.
11. Seino Y, Sasaki T, Fukatsu A, Ubukata M, Sakai S, Samukawa Y. Efficacy and safety of luseogliflozin as monotherapy in Japanese patients with type 2 diabetes mellitus: a randomized, double-blind, placebo-controlled, phase 3 study. Curr Med Res Opin. 2014;30(7):1245–55.
12. Markham A, Elkinson S. Luseogliflozin: first global approval. Drugs. 2014;74(8):945–50.
13. Kuzuya T, Nakagawa S, Satoh J, et al. Committee of the Japan Diabetes Society on the diagnostic criteria of diabetes mellitus. Report of the Committee on the classification and diagnostic criteria of diabetes mellitus. Diabetes Res Clin Pract. 2002;55(1):65–85.
14. Devineni D, Curtin CR, Polidori D, et al. Pharmacokinetics and pharmacodynamics of canagliflozin, a sodium glucose co-transporter 2 inhibitor, in subjects with type 2 diabetes mellitus. J Clin Pharmacol. 2013;53(6):601–10.
15. Heise T, Seman L, Macha S, et al. Safety, tolerability, pharmacokinetics, and pharmacodynamics of multiple rising doses of empagliflozin in patients with type 2 diabetes mellitus. Diabetes Ther. 2013;4(2):331–45.
16. List JF, Woo V, Morales E, Tang W, Fiedorek FT. Sodium-glucose cotransport inhibition with dapagliflozin in type 2 diabetes. Diabetes Care. 2009;32(4):650–7.
17. Schwartz SL, Akinlade B, Klasen S, Kowalski D, Zhang W, Wilpshaar W. Safety, pharmacokinetic, and pharmacodynamic profiles of ipragliflozin (ASP1941), a novel and selective inhibitor of sodium-dependent glucose co-transporter 2, in patients with type 2 diabetes mellitus. Diabetes Technol Ther. 2011;13(12):1219–27.
18. Abdul-Ghani MA, Norton L, DeFronzo RA. Efficacy and safety of SGLT2 inhibitors in the treatment of type 2 diabetes mellitus. Curr Diabetes Rep. 2012;12(3):230–8.
19. Komala MG, Panchapakesan U, Pollock C, Mather A. Sodium glucose cotransporter 2 and the diabetic kidney. Curr Opin Nephrol Hypertens. 2013;22(1):113–9.