Finerenone + Sotagliflozin for Cardio-Renal Complications in Type 1 Diabetes

This trial explores how two drugs, finerenone and sotagliflozin, can help manage heart and kidney issues in people with Type 1 diabetes (T1D). Researchers aim to determine if these medications can prevent or slow damage in individuals whose diabetes affects their heart and kidneys. Participants will receive one of these treatments based on specific health markers. This trial may suit those who have had T1D for over 10 years and face heart or kidney complications despite standard treatments. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

The trial requires that you stop using certain medications before joining. You must not have used aldosterone inhibitors within 2 months, GLP-1 receptor agonists unless stable for at least 2 weeks, or immunosuppressive medications within 3 months prior to screening.

Earlier studies have shown that finerenone is safe for people with type 1 diabetes and chronic kidney disease. Most participants tolerated it well, with side effects similar to those of a placebo (a harmless pill used for comparison). Researchers found no major safety concerns, making it a promising option based on current research.

Research has shown that sotagliflozin can improve heart and kidney health in people with diabetes. However, it carries a slightly higher risk of diabetic ketoacidosis, a serious diabetes complication, compared to a placebo. Overall, the side effects were considered manageable.

Researchers are excited about finerenone and sotagliflozin for treating cardio-renal complications in Type 1 Diabetes because they offer new mechanisms of action compared to standard treatments like insulin and ACE inhibitors. Finerenone is a non-steroidal mineralocorticoid receptor antagonist, which means it helps reduce inflammation and fibrosis without the steroid-related side effects, potentially offering better heart and kidney protection. Sotagliflozin, on the other hand, is a dual inhibitor that targets both SGLT1 and SGLT2 proteins, allowing it to help control blood sugar levels while also reducing the risk of diabetic ketoacidosis and improving kidney function. These unique mechanisms could lead to more comprehensive and safer management of diabetes-related complications.

This trial will compare the effects of Finerenone and Sotagliflozin on cardio-renal complications in people with type 1 diabetes. Studies have shown that Finerenone can reduce kidney damage by lowering protein levels in urine, a marker of kidney issues. Research also suggests that Finerenone can improve heart health by reducing the risk of heart problems.