Lexicon announced that sotagliflozin met its primary endpoint in the inTandem2 Phase 3 study, demonstrating a statistically significant reduction in A1c at 24 weeks in patients with type 1 diabetes on optimized insulin therapy.
The double-blind, placebo controlled study randomized 782 adults with type 1 diabetes on insulin pump or multiple daily injections who had baseline A1c between 7–11%. The study evaluated sotagliflozin 200mg, sotagliflozin 400mg, and placebo. After a 6-week period of insulin optimization, patients were randomized to the two sotagliflozin doses or placebo. Mean baseline A1c levels post-optimization period were 7.80% for the placebo arm, 7.74% for the 200mg arm, and 7.71% for the 400mg arm.
The primary endpoint was the change in A1c from baseline after 24 weeks of treatment. Overall mean placebo-adjusted A1c reduction at Week 24 was 0.36% in the sotagliflozin 200mg arm (P<0.001) and 0.35% in the sotagliflozin 400mg arm (P<0.001).
A third Phase 3 clinical trial, inTandem3, is ongoing and is evaluating 1,400 patients treated with sotagliflozin 400mg once daily vs. placebo on a background of any insulin therapy but without insulin optimization prior to randomization.
Sotagliflozin is a first-in-class, oral dual inhibitor of sodium-glucose co-transporter types 1 and 2 (SGLT1 and SGLT2). SGLT1 serves as the primary transporter for absorption of glucose and galactose in the GI tract. SGLT2 is mainly responsible for glucose reabsorption by the kidney.
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