Abstract Body

PATIENT-REPORTED OUTCOMES IN THE inTANDEM STUDIES AND PROPOSAL FOR A FORWARD-LOOKING STRATEGY ON PATIENT-REPORTED OUTCOMES FOR DIABETIC KIDNEY DISEASE IN TYPE 1 DIABETES

Presenter: Craig Granowitz

Affiliation: Lexicon Pharmaceuticals, Inc., The Woodlands, Texas, USA

Background and aims: Patient-reported outcomes (PROs) provide insight into disease burden. In type 1 diabetes (T1D), treatment satisfaction and diabetes distress are associated with glycemic control. In the inTandem 1 and 2 trials, sotagliflozin, a dual inhibitor of SGLT 1 and 2, was associated with improved glucose control and renal-related measures, reduced hypoglycemia, and increased DKA when added to insulin in patients with T1D. PROs were assessed with sotagliflozin in these trials.

Methods: Diabetes Treatment Satisfaction Questionnaire status (DTSQs) and the 2-item Diabetes Distress Scale (DDS2) were evaluated at baseline and 24 weeks in the inTandem trials. PRO results were pooled for both studies and various analyses were performed including changes in the overall scores and in the individual PRO components.

Results: Sotagliflozin 200 and 400 mg significantly improved DTSQ and DDS2 scores overall and for each component compared to placebo. Among patients at high risk of diabetes distress (DDS2 score ≥6) at baseline, significantly more patients receiving sotagliflozin compared to placebo shifted from high to low risk. In blinded exit interviews, improved glycemic stability (ie, lower HbA1c and less hypoglycemia) was frequently cited by more patients on sotagliflozin, which was consistent with the improvements observed in the DTSQs and DDS2.

Conclusions: The inTandem trials showed that improved glycemic control with sotagliflozin reduced disease burden in T1D. Given the renal complications associated with T1D and the beneficial effects of sotagliflozin on renal-related outcomes, it would be of interest to understand if sotagliflozin impacts PROs applied to kidney disease.