Lexicon Pharma announces positive top-line results from its Phase 3 inTandem3 study of sotagliflozin for the treatment of patients with type 1 diabetes on any background insulin therapy :
The study met its primary endpoint, demonstrating the superiority of sotagliflozin 400 mg compared to placebo in the proportion of patients with A1C less than 7.0% at Week 24 and no episode of severe hypoglycemia and no episode of diabetic ketoacidosis (:DKA) after randomization.
- Sotagliflozin demonstrated a generally well tolerated safety profile during a 24-week treatment period, with rates of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and discontinuations due to AEs that were consistent with rates seen in two prior pivotal Phase 3 studies, inTandem1 and inTandem2, including a similar rate of severe hypoglycemia for the sotagliflozin arm compared to placebo during the 24-week treatment period (2.4% for placebo compared to 3.0% for sotagliflozin 400 mg) and a slightly higher rate of DKA during the 24-week treatment period for sotagliflozin 400 mg (3.0%) than placebo (0.6%).
- A full analysis of the results from inTandem3, including safety data, will be submitted for publication in a peer-reviewed journal.
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