Lexicon Pharmaceuticals announced more positive data from their Phase 3 trial of sotagliflozin, an investigational dual SGLT1 and SGLT2 inhibitor. Earlier results had shown statistically significant reductions in A1C among adults with type 1 diabetes at 24 weeks, while these latest results demonstrate a sustained benefit over 52 weeks.
Sotagliflozin is a first-in-class, dual inhibitor of 2 proteins responsible for glucose regulation. A total of 728patients with type 1 diabetes took part in the double-blind, placebo-controlled study (inTandem2). The subjects were on insulin pump or multiple daily injection therapy with baseline A1C level between 7% and 11%. They were randomized to either sotagliflozin 200mg, 400mg, or placebo.
The overall mean placebo-adjusted A1C reduction at Week 24 was 0.37% in the 200mg dose arm (P<0.001) and 0.35% in the 400mg dose arm (P<0.001); this was sustained over the 52-week duration of the study. Secondary endpoints also met statistical significance for body weight, bolus insulin use, fasting plasma glucose, Diabetes Treatment Satisfaction Questionnaire status (DTSQs) score and 2-item Diabetes Distress Screening Scale (DDS2) questionnaire score.
Overall, sotagliflozin was generally well tolerated. The number of adverse events (AE) experienced among the groups were similar with placebo, 200mg and 400mg having 61.2%, 68.2% and 68.8% incidences, respectively. Serious AEs were experienced by 6.6% (placebo), 10.0% (200mg) and 8.0% (400mg), respectively. Two people died in the placebo arm and none in either sotagliflozin arm.
“Today’s results underscore sotagliflozin’s benefit/risk profile and highlight its differentiated profile in the type 1 diabetes landscape,” said Pablo Lapuerta, MD, Lexicon’s EVP and CMO. “We look forward to presenting more detailed results from the inTandem2 study at an upcoming medical conference.”
For more information visit Lexpharma.com.