A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Effects of SOtagLiflozin on Clinical Outcomes in HemOdynamIcally STable Patients with Type 2 Diabetes POST Worsening Heart Failure

Submitted by MeghanCashman on Fri, 09/13/2019 - 13:27
Study ID
00773
Status
Participant Ages
18-85 Years Old
Study Information

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).

 

Physician
Contact Information
 
Margaret Michaelian
Research Coordinator
     Tel: 617-789-3041
 
 
Clinical Trial Department
Purpose of Trial
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.
Sponsor
Phase
Phase III
Eligibility

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*