Japanese drug maker permitted to start clinical trials of diabetes drug
OSAKA, Japan The Food and Drug Administration has given a Japanese drug maker permission to start clinical trials of a diabetes drug.
Takeda Pharmaceutical Co. announced Friday that the FDA had agreed to the design of a study to examine the effects on cardiovascular safety of the Type 2 diabetes drug alogliptin.
The study will begin next month and end in December 2014, enrolling about 5,400 patients at 1,000 sites in the United States, Europe and Asia.