Lexicon Pharmaceuticals Reports Positive Phase III Data for Sotagliflozin

Lexicon Pharmaceuticals announced additional positive data from the pivotal Phase 3 inTandem2 study of sotagliflozin, an investigational dual SGLT1 and SGLT2 inhibitor. It was previously announced that both doses of sotagliflozin achieved the primary endpoint of the inTandem2 study, showing statistically significant reductions in A1C at 24 weeks in adult patients with type 1 diabetes on a background of optimized insulin. The new data showed that the A1C benefit was sustained over 52 weeks as well as achievement of all secondary endpoints for both sotagliflozin doses. These results of the inTandem2 study, conducted primarily in Europe, replicated results previously reported from Lexicon’s Phase 3 inTandem1 study of sotagliflozin in type 1 diabetes patients, conducted in North America.

Notably, the outcome on every secondary endpoint favored sotagliflozin over placebo, with statistically significant results for all six secondary endpoints for both doses:

net benefit (proportion of patients with A1C <7.0% at Week 24 and no episode of severe hypoglycemia and no episode of diabetic ketoacidosis (DKA);
body weight;
bolus insulin use;
fasting plasma glucose (FPG);
Diabetes Treatment Satisfaction Questionnaire status (DTSQs) score; and
2-item Diabetes Distress Screening Scale (DDS2) questionnaire score.

Systolic blood pressure (SBP) in the subset of type 1 diabetic patients in the study with baseline hypertension (SBP ≥130 mmHg) was also statistically significantly reduced with the 400 mg dose compared with placebo.

Sotagliflozin was generally well tolerated during the 28-week extension period, with rates of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and discontinuations due to AEs that were consistent with rates seen in the initial 24-week treatment period.

“InTandem2 is the second pivotal study to demonstrate sotagliflozin’s ability to durably improve both A1C and other key measures of health such as body weight and blood pressure in patients with type 1 diabetes. Today’s results underscore sotagliflozin’s benefit/risk profile and highlight its differentiated profile in the type 1 diabetes landscape,” said Pablo Lapuerta, M.D., Lexicon’s executive vice president and chief medical officer. “We look forward to presenting more detailed results from the inTandem2 study at an upcoming medical conference.”

“Today’s results are exciting for so many people living with type 1 diabetes,” said Thomas Danne, M.D., Head of the Diabetes Center at the Children’s Hospital on the Bult in Hannover, Germany and primary investigator for the inTandem2 clinical trial. “The observation that sotagliflozin significantly lowers blood glucose and favorably affects body weight and blood pressure without an increase in hypoglycemia strengthens the potential of the drug to become a first-in-class therapy in the treatment paradigm for type 1 diabetes.”