HOME > News Releases > Results of Phase 3 Long-term Administration Clinical Trials of SGLT2 Inhibitor Luseogliflozin Hydrate (TS-071) in Japan Targeting Type 2 Diabetes Mellitus Patients Announced at World Diabetes Congress of IDF

Results of Phase 3 Long-term Administration Clinical Trials of SGLT2 Inhibitor Luseogliflozin Hydrate (TS-071) in Japan Targeting Type 2 Diabetes Mellitus Patients Announced at World Diabetes Congress of IDF

December 3, 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 that the results of the Phase 3 long-term administration clinical trials in Japan of the SGLT2 inhibitor luseogliflozin hydrate (Development Code: TS-071; “luseogliflozin”), which was created by Taisho Pharmaceutical and for which manufacturing and marketing approval is currently filed, at the World Diabetes Congress of the International Diabetes Federation (“IDF”) (http://www.idf.org/worlddiabetescongress/) currently being held in Melbourne, Australia. The results were announced on December 3, 2013 local time.

As described in the following, the results were presented for the two Phase 3 clinical trials conducted in respect of Japanese Type 2 diabetes patients who cannot adequately control their blood glucose levels with the existing oral hypoglycemic agents. The clinical trials comprised Study-1, a long-term administration clinical trial in combined use with sulfonylurea glimepiride, and Study-2, a long-term administration clinical trial in combined use with 5 types of existing oral hypoglycemic agents.

Study-1: This study targeted 221 Japanese Type 2 diabetes patients who cannot adequately control their blood glucose levels with sulfonylurea glimepiride. They were orally administered 2.5 mg of luseogliflozin or a placebo once daily for 24 weeks in a double blind trial. The results showed that the luseogliflozin significantly lowered the hemoglobin A1c (HbA1c), the study’s primary endpoint. At the time of completing the administration, the difference between the HbA1c reduction from the baseline and the placebo was -0.88% (p<0.001). After the period of the double blind trial, 2.5 mg of luseogliflozin (increased to 5 mg in the case that the blood glucose control was inadequate) was administered once daily for a non-blind trial period of up to 52 weeks after the start of administration. The results showed that the luseogliflozin significantly lowered the HbA1c. At the time of completing the administration, the difference between the HbA1c reduction from the baseline was -0.63% (p<0.001).

Study-2: This study targeted 487 Japanese Type 2 diabetes patients who cannot adequately control their blood glucose levels by the single administration of the existing oral hypoglycemic agents of metformin, DPP4-inhibitor, pioglitazone, Glinides, or alpha-glucosidase inhibitor. They were administered with 2.5 mg of luseogliflozin (the dosage was increased to 5 mg in the case that the blood glucose control was insufficient) once daily in a non-blind trial for a period of 52 weeks. The results showed that the luseogliflozin significantly lowered the HbA1c, the study’s primary endpoint, for all combinations with agents. At the time of completing the administration, the difference between the HbA1c reduction from the baseline was -0.52%~-0.68% (p<0.001 for all agent combinations).

Furthermore, as a result of analysis of the secondary endpoints of both studies, luseogliflozin was found to significantly improve the blood glucose levels when fasting and also significantly lower body weight.

As a result of the foregoing, both these studies confirmed that luseogliflozin possesses an excellent effect of blood glucose improvement in the combined administration of the six existing types of oral hypoglycemic agents, 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 development of luseogliflozin, an oral hypoglycemic agent with a new mechanism of action, Taisho Pharmaceutical hopes to provide a new option for treating diabetes 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.

Topics presented at IDF:

Topic number Title Presentation date
(local time)
Presentation form
P-1471 Consistent efficacy of add-on combination of Luseogliflozin with conventional oral antidiabetic drugs in Japanese patients with T2DM December 3 Poster
P-1472 Luseogliflozin, a selective SGLT2 inhibitor, improves glycemic control as monotherapy in Japanese patients with T2DM December 3 Poster



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