TAISHO PHARMA 
By 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%
