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. 

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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.

For more information call or visit LexPharma.com.