Effectiveness and safety of sotagliflozin adjuvant therapy for type 1 diabetes mellitus

Abstract

Background:Type 1 Diabetes Mellitus (T1DM) has long required insulin treatment. Sotagliflflozin (SOTA), as a dual SGLT-1/2 inhibitor, has the potential to be the first oral antidiabetic drug (OAD) to be approved for T1DM in the US market. It is important to evaluate the effectiveness of SOTA for T1DM.Methods:Web of Science, PubMed datebase, Cochrane Library, Embase, Clinical Trials, and CNKI will be searched to identify randomized controlled trials (RCTs) exploring SOTA adjuvant therapy for T1DM. Strict screening and quality evaluation will be performed on the obtained literature independently by 2 researchers; outcome indexes will be extracted. The bias risk of the included studies will be evaluated based on Cochrane assessment tool. Meta-analysis will be performed on the data using Revman 5.3 software.Result:We will provide practical and targeted results assessing the efficacy and safety of SOTA for T1DM patients, to provide reference for clinical use of SOTA.Conclusion:The stronger evidence about the efficacy and safety of SOTA for T1DM patients will be provided for clinicians.Trial registration number:PROSPERO CRD42019133099.

Sodium–glucose cotransporter 2 inhibitors as an add-on therapy to insulin for type 1 diabetes mellitus: Meta-analysis of randomized controlled trials

“…A third study reported that only the risk of DKA should be carefully monitored in SGLT2 inhibitors as adjunctive therapy [50,60]. The latest four studies confirmed that add-on SGLT-2i therapy increased diabetic ketoacidosis and genital tract infections [35,37,40,61].…”

“…Four of these meta-analyses researched studies evaluating the use of SGLT2is in patients with T1DM before 2018 [40,[58][59][60]. In addition, two meta-analyses confirmed that dual SGLT 1/2 inhibitor sotagliflozin adjuvant therapy improves glycemic and nonglycemic outcomes and reduces the rate of hypoglycemia and severe hypoglycemia [37,61].…”