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”. Sotagliflozin works in the kidney to allow more sugar to be lost in the urine, and also in the intestine to prevent absorption of sugars. In this way, it is thought to help in lowering blood sugar in diabetes.
This study has two groups that are decided by chance, active study drug or placebo. This period will continue until enough cardiovascular events have occurred to see if the study drug has benefit in patients with heart failure. It is expected that treatment will continue for about 3 months to 3 years.
The study will consist of 3 periods:
- a screening period (up to 10 days)
- a randomized, double-blind treatment period that will include an initial up-titration period
- a post-treatment period of 14 days (±4 days).
Patients between the ages of 18 to 85 years old, who are diagnosed with Type 2 Diabetes and heart failure and who had event of worsening heart failure and received treatment with intravenous diuretics are eligible.
Patient who prescribed or planning to start other than study medication any other SGLT2 inhibitors, will be excluded. Also, pregnant patients, patients with severe kidney disease, active infection, abnormal liver tests, and high potassium blood test will be excluded.
*For a list of all eligibility criteria please contact the Research Coordinator*