Lexicon Pharmaceuticals has reported positive 52-week results from Phase 3 of the Tandem1 study, a Phase lll trial evaluating sotagliflozin for the treatment of patients with type 1 diabetes.
The double-blind, placebo-controlled trial was conducted at 75 sites across North America.
The trial enrolled 793 adult patients with type 1 diabetes who used an insulin pump or were on multiple injection therapy.
It compared the safety and efficacy of two different doses (200mg or 400mg) of oral sotagliflozin, each used in addition to optimised insulin versus optimised insulin alone.
The trial’s primary endpoint was change from baseline in A1C level at week 24.
Its secondary endpoints are A1C, weight, bolus insulin and FPG changes at week 52, patient reported outcomes and net clinical benefit analysing the proportion of patients with A1C at less than 7% without severe hypoglycemia or DKA.
Results of the trial showed that sotagliflozin, in combination with insulin, significantly reduced A1C levels and weight compared to optimised insulin alone.
A reduced incidence of severe hypoglycemia was also observed with sotagliflozin 200mg and 400mg compared to placebo.
An additional number of patients taking sotagliflozin in combination with optimised insulin achieved the combined goal of an average blood sugar level below the target recommended by American Diabetes Association (ADA) without severe hypoglycemia or diabetic ketoacidosis (DKA).
In addition, 6.5% of patients in each of the sotagliflozin cohorts reported episodes of severe hypoglycemia compared to 9.7% of patients on placebo.
A total of 3.4% of patients taking sotagliflozin at 200mg and 4.2% of patients receiving sotagliflozin at 400mg experienced DKA compared to 0.4% of patients on placebo.
According to the authors of the study, the DKA risk could potentially be mitigated with patient education and monitoring.