Sodium-glucose co-transporter 2 (SGLT2) inhibitors, also called gliflozin drugs, are a new class of diabetic medications. They work by reducing the absorption of glucose via the kidneys with the excess glucose urinated. The FDA has already approved Canagliflozin (Invokana, Invokamet, Invokamet XR) for the treatment of type 2 diabetes.
Lexicon has completed Phase III trials for Type 1 Diabetes.
Top-line results from the Phase 3 study showed that patients treated with sotagliflozin had a mean A1C reduction from baseline of 0.43% on 200mg once daily sotagliflozin dose (p<0.001) and a reduction of 0.49% on 400mg once daily sotagliflozin dose (p<0.001) as compared to a reduction of 0.08% on placebo after 24 weeks of treatment, meeting the study’s primary endpoint. This statistically significant and clinically meaningful improvement in A1C for both doses of sotagliflozin was achieved without an increase in severe hypoglycemia, one of the most prevalent serious health challenges in type 1 diabetes, which was seen less frequently in both treatment arms than placebo. The overall mean placebo-adjusted A1C reduction was 0.35% in the 200mg dose arm (p<0.001) and 0.41% in the 400mg dose arm (p<0.001).
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Lexicon is collaborating with Sanofi for Type 2 applications of sotagliflozin.
Boehringer and Lily announced an alliance in 2011 and empagliflozin is a product of that collaboration.
The trial met its primary efficacy endpoint, which was change from baseline in A1C versus placebo after 26 weeks of treatment. The trial’s secondary endpoints were also met, which included reductions in weight, decreases in blood pressure, and decreases in total daily insulin dose.
Gliflozin drugs seem like they could meaningfully impact treatment results for both T1D and T2D. Most people will welcome the weight reduction benefits and the likely reduction in insulin requirements due to lower overall glucose levels also feels important.