Endocrinology
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Type 1 Diabetes
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SGLT1/SGLT2 inhibitor has another shot in T1D, but now in more narrow patient population
by
Ian Ingram, Managing Editor, MedPage Today
October 30, 2024
FDA staff raised familiar safety concerns about sotagliflozin as a treatment for type 1 diabetes (T1D) as the agency again considers an approval, though now for just a subset with chronic kidney disease (CKD).
On Thursday, members of the Endocrinologic and Metabolic Drugs Advisory Committee will help the FDA decide whether the available data support the dual SGLT1/SGLT2 inhibitor as an adjunct to insulin to improve glycemic control in T1D patients with mild-to-moderate CKD.
Despite the widespread adoption of angiotensin-converting enzyme (ACE) inhibitors or angiotensin II receptor blockers (ARBs), the “risk of progression of CKD remains a significant issue for patients with T1D and comorbid CKD,” FDA staff explained in briefing documents released ahead of the meeting.
While dapagliflozin (Farxiga) and empagliflozin (Jardiance) are approved for CKD in adults at risk of progression — an indication that does encompass people with T1D and CKD — treatment guidelines do not currently recommend the SGLT2 inhibitors in these patients. And concerns remain surrounding the risks for diabetic ketoacidosis (DKA) and hypoglycemia with SGLT2 inhibitors in T1D.
Sotagliflozin has faced a difficult path in T1D. The FDA rejected the drug 5 years ago as an adjunct to insulin for adults with T1D after the agency determined that the drug’s benefits were outweighed by DKA risks, even with a mitigation strategy in place during the drug’s phase III trial program.
Primary support for the new proposed indication includes post-hoc data on the CKD population from three phase III studies — inTandem1, inTandem2, and inTandem3 — that formed the basis for sponsor Lexicon Pharmaceuticals’ original application.
In the briefing documents, FDA’s reviewers again raised concerns about DKA, along with the durability of sotagliflozin’s treatment effect for the proposed indication in T1D with CKD — defined here as those with an estimated glomerular filtration rate (eGFR) of 45 to
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