Lancet Publishes Phase 3 Clinical Data on Basen®
April 23, 2009, Osaka, Japan --- Takeda Pharmaceutical Company Limited (“Takeda”) today announced the publication of an article describing the Phase 3 clinical data of Basen® (generic name: voglibose) —drug for treatment for postprandial hyperglycemia in diabetes mellitus in one of the world’s most prestigious medical journals; The Lancet.
Data published in The Lancet demonstrate that the medicinal treatment by Basen, when being added on the dietary treatment and/or exercise therapy prevents the onset of type 2 diabetes mellitus in subjects with impaired glucose tolerance (“IGT”). The data represents the first clinical evidence with Japanese subjects that showed preventive effects by medicinal treatment of type 2 diabetes. The primary endpoint of the study was onset of type 2 diabetes, and such cases were 50 among 897 cases in the voglibose arm while 106 among 881 cases in the placebo arm, which shows 40.5% decrease in voglibose arm, with statistically significant difference (p=0.0014). With respect to the safety, adverse events such as diarrhea and flatulence were seen more frequently in voglibose arm than placebo arm. However, the overall safety profile shown in voglibose arm is comparable to the results which have been obtained with patients with diabetes, and no severe cases were found.
“It is very gratifying that the clinical data of voglibose is published in such an authoritative medical journal The Lancet,” said Dr. Ryuzo Kawamori, lead author of the paper and Professor, Juntendo University Graduate School. “This data shows the preventive effects of type 2 diabetes by medicinal treatment, when being added on the dietary treatment and/or exercise therapy at the first clinical study with Japanese subjects with IGT. The data is very meaningful since in Japan, the number of patients with diabetes mellitus is increasing every year.”
Based on the data presented on The Lancet this time, Takeda submitted on December 18, 2007 an application to the Ministry of Health, Labour and Welfare in Japan for an additional indication of “Basen® Tablets 0.2” and “Basen® OD Tablets 0.2” for prevention of onset of type 2 diabetes in subjects with IGT. In addition to Basen, Takeda is currently marketing other anti-diabetic agents of different mechanism of action such as Actos® (insulin sensitizer) and Glufast® (short-acting insulin secretagogue), and is contributing to the treatment for more patients with diabetes, offering the optimal medicinal therapies in accordance with the pathologic conditions of individual patients.
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Posted: April 2009