Sotagliflozin Demonstrates Renal Protective Benefits in Diabetic Kidney Disease: Phase 3 Data
Key Insights
A new analysis of the Phase 3 SCORED trial reveals that sotagliflozin provides renal protection in patients with diabetic kidney disease (search) (DKD).
Sotagliflozin showed a placebo-adjusted acute decline in eGFR of -2.59 ml/min/1.73m2/year, indicating an initial impact on kidney function.
The study suggests that sotagliflozin's chronic slope benefit increases with higher baseline albuminuria levels in DKD patients.
Lexicon Pharmaceuticals announced new data from a post-hoc analysis of its Phase 3 SCORED clinical trial, demonstrating the renal protective effects of sotagliflozin in patients with diabetic kidney disease (search) (DKD). The findings were presented at Kidney Week 2024, the annual meeting of the American Society of Nephrology in San Diego, California.
Impact on eGFR Slope
The analysis evaluated the effect of sotagliflozin versus placebo on the Estimated Glomerular Filtration Rate (eGFR) slope, a key indicator of kidney function progression. The study included 10,574 participants. Results showed a placebo-adjusted acute decline in eGFR of -2.59 ml/min/1.73m2/year (95% CI -2.88, -2.30; p<0.0001). The total placebo-adjusted slope was -0.08 ml/min/1.73m2/year (95% CI -0.43, 0.27; p=0.67).
Benefits with Increasing Albuminuria
Compared to placebo, sotagliflozin demonstrated a greater benefit on chronic slope with increasing baseline albuminuria (P-interaction=0.023). This suggests that patients with higher levels of protein in their urine may experience a more pronounced protective effect from sotagliflozin.
Expert Commentary
"Researchers observed positive renal protection with sotagliflozin across a spectrum of baseline kidney function and glycemic control. This study makes an important contribution to understanding the clinical benefits of sotagliflozin for people with diabetic kidney disease (search)," said Craig Granowitz, M.D., Ph.D., Lexicon’s senior vice president and chief medical officer.
About Sotagliflozin
Sotagliflozin is an oral inhibitor of sodium-glucose cotransporter types 2 and 1 (SGLT2 (search) and SGLT1 (search)). SGLT2 is responsible for glucose and sodium reabsorption by the kidney, while SGLT1 is responsible for glucose and sodium absorption in the gastrointestinal tract. Sotagliflozin has been studied in multiple patient populations encompassing heart failure, diabetes (search), and chronic kidney disease (search) in clinical studies involving approximately 20,000 patients. It is marketed as INPEFA® in the United States.