Diabetes Type 2
A multicenter, randomized, double blind, placebo-controlled, phase 3 study to evaluate cardiovascular outcomes of TAK-875, 50 mg in addition to standard of care in subjects with Type 2 diabetes and with cardiovascular disease or multiple risk factors for cardiovascular events.
Sponsored by Takeda Global Research & Development Center
The purpose of this study is to evaluate the risk of cardiovascular events in high risk patients with Type 2 diabetes mellitus when they are treated with TAK-875 as compared with placebo. Patients who are eligible for this study must have had a heart attack within the past two years, or have peripheral vascular disease, or have had a stroke or TIA within the past two years.
Subjects will receive their usual care for their diabetes and will be randomly assigned to receive either a placebo or TAK-875 in addition. The study will last for up to 6 years and will enroll 5000 patients. More information can be found here.
ClinicalTrials.gov Identifier: NCT01609582
Principal Investigator: Christopher Rogers, DO
Study Status: Enrolling
Gail Massey, RN, BS, CCRP