The purpose of the study is show that sotagliflozin does not increase the risk of having a heart attack, stroke or death from a cardiovascular event. In addition, the study is being done to test whether sotagliflozin can, instead, decrease the risk of these events and also to see if sotagliflozin decreases the risk of having heart failure that leads to hospitalization.
The study will last about 4 years and involve about 10,500 participants worldwide. The following paragraphs explain the study in further detail and a table at the end of this section summarizes the main information. The Study has 3 main periods, as follows: 1) The first period (called the screening period): During the screening period, your study doctor will determine if you are eligible to take part in the study (meet all the study requirements) Up to 4 weeks may be needed to collect all information to determine if you are eligible 2) The second period (called a double-blind treatment period): This is a double-blind treatment period during which the study drug will be taken. Double blind means that neither you nor your doctor will know whether you will receive the active study drug or placebo. A placebo looks exactly like the active study drug but does not contain the active medicine. You will not be able to tell whether you are receiving the active study drug or placebo. You have an equal chance of being assigned to either group. In the event of an emergency, the study doctor will have the ability to find out which treatment you have been given. The term “study drug” refers to both sotagliflozin and the placebo in this form. This period will continue until enough cardiovascular events have occurred to be able to tell whether there was a difference in the outcomes with the active study drug or placebo. It is expected that you will be on treatment from between approximately 2 to 4 years, depending on when you start being in the study. 3) The third period (called the follow-up period) This period is to report any adverse event (any discomforts and health issues) that may have occurred after the last study treatment was taken whether they are felt to be related to the study treatment or not. This period will last about two weeks. If you agree to take part in this study and meet all the study requirements, you will be assigned to one of the 2 following groups (decided by chance, like the flip of a coin): active study drug or placebo. You will also have to undergo the following tests and procedures: