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New Post Hoc Analysis of inTandem3 Study Demonstrates Improvements In Glycemic Control With Sotagliflozin Treatment in Patients With Type 1 Diabetes and Chronic Kidney Disease
Mar 12, 202408:00 EDT
 LXRX+7.00%
THE WOODLANDS, Texas, March 12, 2024 (GLOBE NEWSWIRE) — Lexicon Pharmaceuticals, Inc. LXRX today announced that a post hoc analysis of clinical data from its inTandem3 Phase 3 trial demonstrated that treatment with sotagliflozin resulted in improved glycemic control in patients with type 1 diabetes and chronic kidney disease (CKD). In this important patient population, treatment with sotagliflozin successfully lowered A1C, body weight, and systolic blood pressure with safety similar to the total study cohort.
The efficacy and safety data were presented last week at ATTD 2024 - 17th International Conference on Advanced Technologies and Treatments for Diabetes in Florence, Italy.
Using data from the 24-week, multinational, placebo-controlled trial, the effects of sotagliflozin 400 mg daily added to insulin therapy on A1C, body weight, systolic blood pressure, eGFR, total insulin dose, adjudicated severe hypoglycemia and DKA were evaluated in a subgroup of patients (228 [16.3%] of 1402]) with type 1 diabetes and CKD (eGFR <60 mL/min/1.73 m2 and/or UACR =30 mg/g).
Relative to placebo, treatment with sotagliflozin led to similar reductions in A1C, body weight and systolic blood pressure in the CKD and total cohorts. Sotagliflozin was associated with similar risks of severe hypoglycemia between the two cohorts.
“Our research team concluded that in patients with type 1 diabetes and CKD, treatment with sotagliflozin had similar A1C, body weight and systolic blood pressure lowering effects as compared to its effect on the total cohort” said David Z.I. Cherney, M.D., Ph. D., Professor in the Department of Medicine at the University of Toronto, and a contributing author of the abstract presented March 7, 2024, at ATTD.
“This research adds important data to the body of evidence supporting our plans to resubmit our New Drug Application for sotagliflozin as an adjunct to insulin therapy in people with type 1 diabetes and CKD,” said Craig Granowitz, M.D., Ph.D., Lexicon’s senior vice president and chief medical officer. “We are optimistic that sotagliflozin may become an important new treatment option for this important population.” |
