Lexicon announced positive findings from the pivotal Tandem 1 study, a Phase 3 trial of sotagliflozin for the treatment of type 1 diabetes.
Tandem 1 was a double-blind, placebo-controlled study evaluating two doses of sotagliflozin, 200mg and 400mg once daily, vs. placebo in 793 patients with type 1 diabetes on insulin pump or multiple daily injection therapy who had baseline A1C of 7%–11% (estimated average blood sugar of 154-269 mg/dl). The primary endpoint was change in A1C from baseline after 24 weeks of treatment. The study had a long-term extension phase of 28-weeks for a total treatment duration of 52 weeks.
Results from the trial demonstrated that patients treated with sotagliflozin achieved a statistically significant reduction in A1C at 24 weeks, meeting the study’s primary endpoint. Patients treated with the 200mg dose had an A1C reduction from baseline of 0.43% (P<0.001), while those treated with the 400mg achieved a reduction of 0.49% (P<0.001), compared to placebo’s 0.08%. After a total treatment duration of 52 weeks, patients in the 200mg dose arm achieved an overall mean placebo adjusted A1C reduction of 0.35%, and 0.41% in the 400mg dose arm (P<0.001 for both).
The study found sotagliflozin to be generally well-tolerated, with similar rates of treatment-emergent adverse events (AEs) across all three arms. Significant improvements in A1C for both sotagliflozin doses were not associated with an increase in the incidence of severe hypoglycemia. Patients treated with the 200mg and 400mg doses experienced less frequent severe hypoglycemia events compared to placebo-treated patients during the 24-week treatment period, with an incidence of 4.2%, 4.6%, and 6.7%, respectively.
Lexicon is conducting additional Phase 3 trials for sotagliflozin in type 1 and type 2 diabetes.
Sotagliflozin is an oral, first-in-class, dual inhibitor of sodium-glucose co-transporter types 1 and 2 (SGLT1 and SGLT2).
For more information visit Lexpharma.com.