Sotagliflozin, a dual SGLT1 and SGLT2 inhibitor, is a promising option as adjunct therapy for type 1 diabetes patients…
In a randomized double blind phase 2 study, 33 type 1 diabetic patients were treated with either sotagliflozin or placebo. Researchers assessed safety, glycemic control, bolus insulin dose reduction which was the primary endpoint, and other related parameters over a period of 29 days.
Results of the study showed statistically significant reductions in A1C (0.55% reduction in the sotagliflozin group and a 0.06% reduction in the control group; p=0.002); bolus insulin dose reduction of an average of 32% and 6.4% in the sotagliflozin and control groups, respectively; and a body weight reduction of 1.7kg in the sotagliflozin group and a 0.5kg weight gain in the placebo group. Those placed in the treatment group also experienced more time in the target glucose range of 70-180 mg/dL.
Results of the study showed an insignificant reduction in basal insulin and the number of hypoglycemic events was insignificant with a decrease by 0.7 in the treatment group and 0.4 in the placebo group.
When looking at adverse events, 88% (n=14) of patients in the sotagliflozin group and 71% (n=12) in the control group reported; however none of these reports led to the patient opting out of the study. GI distress was most commonly reported with 8 in the treatment group and 3 in the placebo group. Nausea was reported by three patients in the treatment group and by one patient in the control group. DKA was reported by two patients in the treatment group, however this was related to their use of insulin pumps rather than the initiation of sotagliflozin.
This study shows that the use of an oral SGLT inhibitor can be beneficial for type 1 diabetics and showed significant results in lowering weight, A1C and mealtime insulin.
- Sotagliflozin, a dual SGLT inhibitor, showed reductions in A1C, body weight and in bolus insulin doses over a 29-day study.
- Additional research on different patient populations would be beneficial in further looking into safety and efficacy.
“Sotagliflozin, a Dual SGLT1 and SGLT2 inhibitor, as Adjunct Therapy to Insulin in Type 1 Diabetes” presented by Dr. John Buse, Professor of Medicine and Chief of the Endocrinology Division at UNC Chapel Hill at the ADA Scientific Sessions, Boston, June 2015.
Arthur T. Sands. Sotagliflozin, a Dual SGLT1 and SGLT2 Inhibitor, as Adjunct Therapy to Insulin in Type 1 Diabetes. Published online before print June 6, 2015, doi: 10.2337/dc14-2806. Diabetes Care June 6, 2015.