Lexicon Pharma announces positive data from the pivotal Phase 3 inTandem2 study of sotagliflozin, an investigational dual SGLT1 and SGLT2 inhibitor
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 all secondary endpoints favored sotagliflozin over placebo, with statistically significant results for all six secondary endpoints for both doses:
- net benefit
- 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.
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