Efficacy and safety of ipragliflozin as an add-on to a sulfonylurea in Japanese patients with inadequately controlled type 2 diabetes: results of the randomized, placebo-controlled, double-blind, phase III EMIT study

被引：52

作者：

Kashiwagi A. ^{[1
]}

Akiyama N. ^{[2
]}

Shiga T. ^{[2
]}

Kazuta K. ^{[2
]}

Utsuno A. ^{[2
]}

Yoshida S. ^{[2
]}

Ueyama E. ^{[2
]}

机构：

[1] Shiga University of Medical Science, Shiga

[2] Astellas Pharma Inc., 2-5-1, Nihonbashi-Honcho, Chuo-ku, Tokyo

来源：

Diabetology International | 2015年 / 6卷 / 2期

关键词：

Ipragliflozin; Japanese patients; Randomized controlled trial; SGLT2; Sulfonylurea; Type; 2; diabetes;

D O I：

10.1007/s13340-014-0184-9

中图分类号：

学科分类号：

摘要：

Sulfonylureas are often used alone or in combination with other drugs for treating type 2 diabetes. Ipragliflozin is a sodium/glucose cotransporter 2 inhibitor that enhances urinary glucose excretion and improves glycemic control. We examined the efficacy and safety of ipragliflozin as an add-on to a sulfonylurea in Japanese type 2 diabetes patients with inadequate glycemic control in a phase III study. Patients were randomized, double-blind, to 50 mg ipragliflozin or placebo for 24 weeks, followed by a 28-week open-label extension in which all patients received either 50 or 100 mg ipragliflozin. The primary endpoint was the change in HbA1c from baseline to week 24 (last observation carried forward). Overall, 166 patients were prescribed ipragliflozin and 77 were prescribed placebo. The adjusted mean change in HbA1c from baseline to week 24 between the ipragliflozin and placebo groups was −1.14 % (P < 0.001). The reductions in fasting plasma glucose and body weight were significantly greater in the ipragliflozin group (placebo-adjusted mean change: −38.0 mg/dl and −1.32 kg, respectively; both, P < 0.001). These changes were maintained until the end of the open-label extension. There were more treatment-emergent adverse events in the ipragliflozin group than in the placebo group (75.9 vs. 61.8 %; P = 0.032). The most common adverse events with a higher incidence in the ipragliflozin group than in the placebo group were mild pollakiuria and thirst. Ipragliflozin as an add-on to a sulfonylurea significantly improved glycemic control and reduced body weight, with good tolerability, in Japanese type 2 diabetes patients. © 2014, The Japan Diabetes Society.

引用

页码：125 / 138

页数：13

共 24 条

[1]

Sabolic I., Vrhovac I., Eror D.B., Gerasimova M., Rose M., Breljak D., Ljubojevic M., Brzica H., Sebastiani A., Thal S.C., Sauvant C., Kipp H., Vallon V., Koepsell H., Expression of Na<sup>+</sup>-d-glucose cotransporter SGLT2 in rodents is kidney-specific and exhibits sex and species differences, Am J Physiol Cell Physiol, 302, pp. C1174-C1188, (2012)

[2]

Bakris G.L., Fonseca V.A., Sharma K., Wright E.M., Renal sodium-glucose transport: role in diabetes mellitus and potential clinical implications, Kidney Int, 75, pp. 1272-1277, (2009)

[3]

Wright E.M., Renal Na<sup>+</sup>-glucose cotransporters, Am J Physiol Renal Physiol, 280, pp. F10-F18, (2001)

[4]

Nair S., Wilding J.P., Sodium glucose cotransporter 2 inhibitors as a new treatment for diabetes mellitus, J Clin Endocrinol Metab, 95, pp. 34-42, (2010)

[5]

Neumiller J.J., White J.R., Campbell R.K., Sodium-glucose co-transport inhibitors: progress and therapeutic potential in type 2 diabetes mellitus, Drugs, 70, pp. 377-385, (2010)

[6]

Veltkamp S.A., Kadokura T., Krauwinkel W.J., Smulders R.A., Effect of ipragliflozin (ASP1941), a novel selective sodium-dependent glucose co-transporter 2 inhibitor, on urinary glucose excretion in healthy subjects, Clin Drug Investig, 31, pp. 839-851, (2011)

[7]

Kadokura T., Saito M., Utsuno A., Kazuta K., Yoshida S., Kawasaki S., Nagase I., Kageyama S., Ipragliflozin (ASP1941), a selective sodium-dependent glucose cotransporter 2 inhibitor, safely stimulates urinary glucose excretion without inducing hypoglycemia in healthy Japanese subjects, Diabetol Int, 2, pp. 172-182, (2011)

[8]

Schwartz S.L., 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, 13, pp. 1219-1227, (2011)

[9]

Fonseca V.A., Ferrannini E., Wilding J.P., Wilpshaar W., Dhanjal P., Ball G., Klasen S., Active- and placebo-controlled dose-finding study to assess the efficacy, safety, and tolerability of multiple doses of ipragliflozin in patients with type 2 diabetes mellitus, J Diabetes Complicat, 27, pp. 268-273, (2013)

[10]

Kashiwagi A., Kazuta K., Yoshida S., Nagase I., 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, J Diabetes Investig, (2013)

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