HOME > News Releases > SGLT2 Inhibitor Luseogliflozin Hydrate (TS-071): Results of Phase 3 Clinical Trials in Japan Targeting Type 2 Diabetes Mellitus Patients Announced at the 49th Annual Meeting of EASD

SGLT2 Inhibitor Luseogliflozin Hydrate (TS-071)
Results of Phase 3 Clinical Trials in Japan Targeting Type 2 Diabetes Mellitus Patients Announced at the 49th Annual Meeting of EASD

September 26, 2013

Taisho Pharmaceutical Holdings Co., Ltd. has announced that its consolidated subsidiary Taisho Pharmaceutical Co., Ltd. (“Taisho Pharmaceutical”) [Head Office: Toshima-ku, Tokyo; President: Shigeru Uehara] announced the results of Phase 3 clinical trials in Japan of the SGLT2 inhibitor luseogliflozin hydrate (Development Code: TS-071; “luseogliflozin”), which was created by Taisho Pharmaceutical, at the 49th Annual Meeting of the European Association for the Study of Diabetes (“EASD”) (http://www.easd2013.com/) currently being held in Barcelona, Spain. The results were announced on September 25, 2013 local time.

Yutaka Seino, President of Kansai Electric Power Hospital, presented the following two Phase 3 clinical trials targeting Japanese Type 2 diabetes mellitus patients: a placebo-controlled double-blind study (“Study-1”) and a monotherapy, long-term treatment study (“Study-2”).

Study-1: In this Phase 3, a double-blind, placebo-controlled study targeting 158 Japanese Type 2 diabetes mellitus patients, either 2.5 mg of luseogliflozin or a placebo was administered orally once daily for 24 weeks. The study confirmed that luseogliflozin significantly reduced hemoglobin A1c (HbA1c), the study’s primary endpoint. At the time of completing drug administration, the difference between the HbA1c reduction from the baseline and the placebo was -0.75% (p<0.001).

Study-2: In this Phase 3, an open-label, long-term treatment study targeting 299 Japanese Type 2 diabetes mellitus patients, 2.5 mg of luseogliflozin was administered orally once daily for 52 weeks (the dosage was increased to 5 mg when glycemic control was insufficient). The study found that luseogliflozin significantly reduced the level of HbA1c, the study’s primary endpoint. The HbA1c reduction from the baseline was -0.50% (p<0.05).

Furthermore, as a result of analysis of the secondary endpoints of both studies, luseogliflozin was found to significantly improve postprandial blood glucose levels two hours after meals and fasting blood glucose levels, while also significantly lowering body weight and abdominal circumference.

As a result of the foregoing, the studies confirmed that luseogliflozin has a high blood glucose-lowering effect in single-agent administration and that the effect was maintained for 52 weeks without attenuation. At the same time, the studies confirmed luseogliflozin’s excellent safety profile.

Through the marketing of luseogliflozin, an oral hypoglycemic agent with a new mechanism of action, by Taisho Pharmaceutical, we intend to provide a new diabetes treatment option to many more patients.


(Reference)
About Luseogliflozin
Luseogliflozin is a drug with a new mechanism of action that selectively inhibits sodium-glucose cotransporter 2 (SGLT2). It lowers blood glucose levels by inhibiting reabsorption of glucose in the renal tubule, thus increasing urinary glucose excretion. Luseogliflozin is a drug for which a large amount of clinical evidence has been amassed from Japanese patients, with all steps from drug discovery to development undertaken by Taisho Pharmaceutical in Japan.

Five Phase 3 clinical trials in Japan (targeting 1,310 Type 2 diabetes mellitus patients) have confirmed the blood glucose-lowering effect of luseogliflozin on HbA1c, an indicator used to control blood glucose levels, both in monotherapy and in combined administration with other oral hypoglycemic agents. At the same time, the trials confirmed that there were no safety issues. Taisho Pharmaceutical has filed for marketing approval of luseogliflozin for the indication of Type 2 diabetes mellitus. Since luseogliflozin has a different mechanism of action than traditional oral hypoglycemic agents, luseogliflozin is set to become a Type 2 diabetes mellitus treatment that can be administered in combination with a broad range of other oral antihyperglycemic drugs, as well as a new diabetes treatment option in its own right.



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