Study of Sotagliflozin Tablets to Improve Quality of Life in Adults With Type 1 Diabetes and Heart Failure

What this Trial Is About

This research is focused on people with type 1 diabetes who also have symptoms of heart failure, a condition that can cause breathlessness, tiredness, and swelling. The study aims to find out if sotagliflozin, a tablet medication, can improve quality of life and heart failure symptoms for these individuals. While sotagliflozin has shown benefits in people with type 2 diabetes and heart failure, its effects on those with type 1 diabetes are not yet known. Participants will be randomly assigned to receive either sotagliflozin tablets or placebo tablets, which look identical but contain no active medicine. They will take one tablet daily for 16 weeks. This is a double-blind trial, meaning neither the researchers nor participants will know which treatment is being taken until the study ends. The trial will last about 6 months per participant, with the entire study expected to run for about 26 months. During the study, participants will have their heart failure symptoms and quality of life assessed using questionnaires like the Kansas City Cardiomyopathy Questionnaire KCCQ. Other evaluations include walking tests, blood tests for heart and diabetes markers, and monitoring for safety concerns like low blood sugar or diabetic ketoacidosis. The study will measure changes in these outcomes from the start to week 16, with ongoing safety follow-up until week 20.

Sotagliflozin in Patients With Heart Failure Symptoms and Type 1 Diabetes