Sotagliflozin (SAR439954) is a medicine you take by mouth that is being developed by Sanofi for the potential treatment of type 2 diabetes (T2DM). Sotagliflozin is an "investigational drug". The purpose of the study is to show that sotagliflozin can decrease the risk of cardiovascular death, or decreases the risk of being hospitalized for heart failure. Furthermore, the study will observe whether sotagliflozin reduces the risk of kidney disease, or if sotagliflozin could lead to changes in the way you use other medications. The study will last about 3 years and involve about 4000 participants. The Study has 3 main periods, as follows: Screening, a Double-Blind Treatment period, and a Follow-Up period.
INVESTED is a multi-site trial comparing high-dose (60 ?g per vaccine viral strain) trivalent influenza vaccine to standard-dose (15 ?g per viral strain) quadrivalent influenza vaccination for up to three influenza seasons in high-risk cardiovascular disease patients with a history of myocardial infarction in the previous 12 months OR history of heart failure hospitalization in the previous 24 months. Subjects will be randomly assigned to receive either the high-dose or standard-dose vaccine.