Randomized, placebo-controlled, double-blind glycemic control trial of novel sodium-dependent glucose cotransporter 2 inhibitor ipragliflozin in Japanese patients with type 2 diabetes mellitus

Journal of Diabetes Investigation

Volumn 5, Issue 4, 2014, Pages 382-391

  Kashiwagi, Atsunori ^a   Kazuta, Kenichi ^b   Yoshida, Satoshi ^b   Nagase, Itsuro ^b  

^a SHIGA UNIVERSITY OF MEDICAL SCIENCE   (Japan)

^b ASTELLAS PHARMA INC   (Japan)

Author keywords

Hyperglycemia; Oral antidiabetic drugs; Sodium dependent glucose co transporter 2

Indexed keywords

GLUCOSE; HEMOGLOBIN A1C; IPRAGLIFLOZIN; NITROGEN; PLACEBO; UREA;

ADULT; AGED; ARTICLE; BODY WEIGHT; CLINICAL EFFECTIVENESS; CLINICAL EVALUATION; CONTROLLED STUDY; CYSTITIS; DOSE RESPONSE; DOUBLE BLIND PROCEDURE; DRUG DOSE COMPARISON; DRUG EFFICACY; DRUG FATALITY; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; FEMALE; GENITAL PRURITUS; GLUCOSE BLOOD LEVEL; GLYCEMIC CONTROL; HEMATOCRIT; HEMOGLOBIN BLOOD LEVEL; HUMAN; HYPOGLYCEMIA; JAPANESE (PEOPLE); MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; NON INSULIN DEPENDENT DIABETES MELLITUS; OBESITY; POLLAKISURIA; POLYURIA; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; TREATMENT DURATION; TREATMENT OUTCOME; UREA NITROGEN BLOOD LEVEL; URINARY TRACT INFECTION; VAGINA CANDIDIASIS; VAGINITIS; WEIGHT REDUCTION;

EID: 84904697900     PISSN: 20401116     EISSN: 20401124     Source Type: Journal    
DOI: 10.1111/jdi.12156     Document Type: Article

References (26)

1. Shaw JE, et al. Global estimates of the prevalence of diabetes for 2010 and 2030. Diabetes Res Clin Pract 2010; 87: 4-14.
2. Ministry of Health, Labour and Welfare. 2007. National Health and Nutrition Survey. http://www.mhlw.go.jp/houdou/2008/12/h1225-5a.html (Japanese).
3. Kobayashi M, Yamazaki K, Hirao K, et al. The status of diabetes control and antidiabetic drug therapy in Japan-A cross-sectional survey of 17, 000 patients with diabetes mellitus (JDDM 1). Diabetes Res Clin Pract 2006; 73: 198-204.
4. Wright EM. Renal Na(+)-glucose cotransporters. Am J Physiol Renal Physiol 2001; 280: F10-F18.
5. Kanai Y, Lee WS, You G, et al. The human kidney low affinity Na+/glucose cotransporter SGLT2. Delineation of the major renal reabsorptive mechanism for D-glucose. J Clin Invest 1994; 93: 397-404.
6. Neumiller JJ, White JR Jr, Campbell RK. Sodium-glucose co-transport inhibitors: progress and therapeutic potential in type 2 diabetes mellitus. Drugs 2010; 70: 377-385.
7. Washburn WN. Evolution of sodium glucose co-transporter 2 inhibitors as anti-diabetic agents. Expert Opin Ther Pat 2009; 19: 1485-1499.
8. Tahara A, Kurosaki E, Yokono M, et al. Pharmacological profile of ipragliflozin (ASP1941), a novel selective SGLT2 inhibitor, in vitro and in vivo. Naunyn Schmiedebergs Arch Pharmacol 2012; 385: 423-436.
9. Tahara A, Kurosaki E, Yokono M, et al. Antidiabetic effects of SGLT2-selective inhibitor Ipragliflozin in streptozotocin-nicotinamide-induced mildly diabetic mice. J Pharmacol Sci 2012; 120: 36-44.
10. Veltkamp SA, Kadokura T, Krauwinkel WJ, et al. Effect of Ipragliflozin (ASP1941), a novel selective sodium-dependent Glucose co-transporter 2 inhibitor, on urinary glucose excretion in healthy subjects. Clin Drug Investig 2011; 31: 839-851.
11. Kadokura T, Saito M, Utsuno A, et al. Ipragliflozin (ASP1941), a selective sodium-dependent glucose cotransporter 2 inhibitor, safely stimulates urinary glucose excretion without inducing hypoglycemia in healthy Japanese subjects. Diabetol Int 2011; 2: 172-182.
12. 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.
13. Atsunori K, Masato K, Eiichi A, et al. International clinical harmonization of glycated hemoglobin in Japan: from Japan diabetes society to national glycohemoglobin standardization program values. J Diabetes Invest 2012; 3: 39-49.
14. Matsuzawa Y, Inoue S, Ikeda Y, et al. The new diagnostic criteria of obesity. J Japan Soc for Study Obesity 2000; 6: 18-28 (Japanese).
15. Stratton IM, Adler AI, Neil HA, et al. Association of glycaemia with macrovascular and microvascular complications of type 2 diabetes (UKPDS 35): prospective observational study. BMJ 2000; 321: 405-412.
16. List JF, Woo V, Morales E, et al. Sodium-glucose cotransport inhibition with dapagliflozin in type 2 diabetes. Diabetes Care 2009; 32: 650-657.
17. Wilding JP, Norwood P, T'joen C, et al. 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.
18. Kaku K, Inoue S, Matsuoka O, et al. Efficacy and safety of dapagliflozin as a monotherapy for type 2 diabetes mellitus in Japanese patients with inadequate glycemic control: a phase II multicentre, randomized, double-blind, placebo-controlled trial. Diabetes Obes Metab 2013; 15: 432-440.
19. 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.
20. Hollander PA, Kushner P. Type 2 diabetes comorbidities and treatment challenges: rationale for DPP-4 inhibitors. Postgrad Med 2010; 122: 71-80.
21. Schwartz SL, Akinlade B, Klasen S, et al. 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: 1219-1227.
22. Liu J, Lee TW, DeFronzo RA. Why do SGLT2 inhibitors inhibit only 30-50% of renal glucose reabsorption in human? Diabetes 2012; 61: 2199-2204.
23. American Diabetes Association. Executive summary: standards of medical care in diabetes-2012. Diabetes Care 2012; 35(Suppl. 1): S4-S10.
24. Ferrannini E, Ramos SJ, Salsali A, et al. Dapagliflozin monotherapy in type 2 diabetic patients with inadequate glycemic control by diet and exercise: a randomized, double-blind, placebo-controlled, phase 3 trial. Diabetes Care 2010; 33: 2217-2224.
25. Sobel JD. Candidal vulvovaginitis. Clin Obstet Gynecol 1993; 36: 153-165.
26. Komoroski B, Vachharajani N, Feng Y, et al. 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.