BACKGROUND AND AIMS: Sotagliflozin (SOTA) is a dual SGLT1 and SGLT2 inhibitor in Phase 3 development for type 2 and as adjunct to insulin in type 1 diabetes (T1D). In a Phase 3 study (inTandem 1) after 24 weeks, SOTA 200 and 400 mg adjunctive to insulin resulted in higher glycemic control versus insulin alone (plus placebo). A qualitative study was conducted with inTandem 1 participants to better understand experiences with T1D before and during the study.
MATERIALS AND METHODS: All participants who completed or discontinued early from US and Canadian clinical sites, within the past 12 months, were invited to participate in an individual phone interview. Trial sites referred participants sequentially, starting with those who exited the study most recently. All parties were blinded to treatment assignment. Open-ended questions were posed to ascertain a full understanding of the participants’ experiences both before and during the trial, including their experience related to trial-related ketone monitoring. Follow-up probes addressed treatment satisfaction and the importance and impact of reported treatment benefits. Importance of symptom improvement was rated on a 5-point scale ranging from “Not at all important” to “Extremely important”. Thematic methods were used to analyze the interview transcripts and descriptive statistics were computed for quantitative data. All study procedures were approved by central Institutional Review Boards.
RESULTS: Results were pooled across treatment arms. Thirty-two participants with characteristics representative of the overall study population, completed a phone interview. All participants reported challenges in achieving glycemic control prior to the trial, characterized by frequent “high” (n=31) and “low” (n=24) blood sugar events, included high HbA1c levels (n=29), lack of glucose stability (n=27), and increased insulin use (n=18). Participants reported feelings of stress/worry about T1D (n=21), low energy levels that reduced productivity/physical activity (n=20), and negative impacts on mood including feeling depressed and/or irritable (n=21). Participants who reported greater glucose instability generally reported greater negative impacts across various areas of their lives. Twenty-six participants (81%) reported at least 1 improvement during the trial, including reduction in the frequency of hyperglycemic (n=26) and hypoglycemic (n=14) events, greater glucose stability and reduced insulin use (both n=23), and lower HbA1c levels (n=21). Improvements most frequently reported as “very important” or “extremely important” included reductions inHbA1c levels (95%) and greater glucose stability (91%). Improvements in T1D symptoms were associated with feeling happier, less stressed/worried, and more in control of T1D. Participants also noted increased energy and improved quality of life related to improved glucose stability. The ketone monitoring requirement was accepted by participants and was not noted as burdensome. No new safety signals were identified.
CONCLUSION: In this Phase 3 study, interview participants consistently reported that improvement in glycemic stability/control was meaningful and that this improvement had a significant positive impact both clinical and emotional on their lives.
