What is the impact of sotagliflozin as adjunct to insulin therapy on diabetes distress and treatment satisfaction in patients with type 1 diabetes?
Sodium-glucose co-transporter-2 inhibitors (SGLT-2 inhibitors), such as sotagliflozin, are antihyperglycemic agents approved for use in patients with type 2 diabetes. However, previous studies have shown that the adjunct use of sotagliflozin with insulin is associated with more significant A1C improvements, fewer hypoglycemic events, increased weight loss, and lower insulin dose requirements in patients with type 1 diabetes. Tandem1 and Tandem2 were double-blinded clinical trials conducted in 2018 to evaluate the safety and efficacy of the addition of sotagliflozin to insulin therapy in patients with type 1 diabetes. A post-hoc analysis of these trials was conducted to assess the impact of sotagliflozin on patient-reported outcomes (PROs) such as treatment satisfaction and diabetes distress.
The PROs were assessed in the placebo group and both the sotagliflozin 200 mg and sotagliflozin 400 mg groups. Treatment satisfaction was evaluated using the eight-item Diabetes Treatment Satisfaction Questionnaire (DTSQ), and a clinically significant change was defined as a greater than a three-point increase in total score from baseline (assessed in patients with a baseline score <32). Diabetes distress was evaluated using the two-item Diabetes Distress Scale (DDS2), and shifts from high (>6 points) to low risk (<6 points) category were evaluated. Results were taken from the first 24 weeks of data from the Tandem1 and Tandem2 clinical trials.
Baseline population characteristics were well-balanced between placebo and both intervention groups. The average age was 44 years, the average baseline A1C was 7.7%, and most of the patients were Caucasian (>90%). The average baseline DTSQs score was 28.5, and the average baseline DDS2 score was 5.2. Results showed a significantly (P<0.001) more significant improvement in the DTSQs score at week 24 with sotagliflozin than with placebo. The baseline-adjusted difference in DTSQs score was 2.3 for sotagliflozin 200 mg and 2.1 for sotagliflozin 400 mg. Nearly twice as many patients with a baseline score <32 that were treated with sotagliflozin 200 mg (45.9%) or sotagliflozin 400 mg (42.3%) had an improvement of greater than three points in their DTSQs score when compared to patients given a placebo (24%).
Furthermore, the use of sotagliflozin resulted in a statistically significant reduction in the DDS2 score (P<0.001), while the placebo increased the DDS2 score. The baseline adjusted difference was -0.5 in the sotagliflozin 200 mg group and -0.6 in the sotagliflozin 400 mg group. A greater proportion of patients shifted from high to low risk in the treatment group than in the placebo group, with 40.4% in sotagliflozin 200 mg, 40.2% in sotagliflozin 400 mg, and 23.3% in placebo (P<0.0002) undergoing this shift. Moreover, there was an increase in patients who shifted from the low to the high-risk group in the placebo group when compared to the sotagliflozin group, with 3% in sotagliflozin 200 mg, 9.4% in sotagliflozin 400 mg, and 21.3% in placebo (P<0.01) undergoing this shift.
In conclusion, the addition of sotagliflozin to insulin therapy in patients with type 1 diabetes resulted in significant improvements in both treatment satisfaction and diabetes distress at the end of week 24 compared to placebo. Patients reported that the increased glycemic stability and glycemic control led to the observed benefits in their DTSQs and DDS2 scores. Sotagliflozin allowed patients to experience fewer hypoglycemic events, further control A1C levels, and reduce insulin requirements. Poor satisfaction with therapy has previously been associated with lower adherence, inadequate glycemic control, and a greater risk of complications. Therefore, providers should improve the quality of life and therapy burden when prescribing antihyperglycemics to enhance patient satisfaction. Sotagliflozin offers this benefit when it comes to positively affecting the patient’s quality of life.
- Sotagliflozin offers quality of life benefits when added as adjunct to insulin therapy in patients with type 1 diabetes.
- Sotagliflozin improves treatment satisfaction scores and diabetes distress, leading to improved glycemic control and treatment outcomes.
- A patient-specific approach should consider patients’ overall well-being rather than A1C reduction alone when initiating therapy for patients with type 1 diabetes.
Danne T, Joish VN, Afonso M, et al. “Improvement in Patient-Reported Outcomes in Adults with Type 1 Diabetes Treated with Sotagliflozin plus Insulin Versus Insulin Alone.” Diabetes Technol Ther. 2021.
Danne, Thomas et al. “HbA1c and Hypoglycemia Reductions at 24 and 52 Weeks With Sotagliflozin in Combination With Insulin in Adults With Type 1 Diabetes: The European inTandem2 Study.” Diabetes care vol. 41,9 (2018): 1981-1990.
Buse, John B et al. “Sotagliflozin in Combination With Optimized Insulin Therapy in Adults With Type 1 Diabetes: The North American inTandem1 Study.” Diabetes care vol. 41,9 (2018): 1970-1980.
Macrina Ghali, PharmD Candidate 2021, Florida A&M University, College of Pharmacy and Pharmaceutical Sciences