INTRODUCTION: The majority of patients with type 1 diabetes mellitus (T1DM) do 
not achieve glycemic targets. In addition, treatment with insulin is associated 
with increased risk for hypoglycemia and weight gain. Accordingly, there is an 
unmet need for new safe and effective glucose-lowering agents in this 
population. Sotagliflozin, a dual inhibitor of sodium-glucose co-transporters 1 
and 2, has been recently approved for use in patients with T1DM.
AREAS COVERED: The authors review the major trials that have evaluated the 
safety and efficacy of sotagliflozin and provide their expert opinion.
EXPERT OPINION: Even though sotagliflozin reduces HbA1 c levels and does not 
appear to increase the risk for hypoglycemia in most patients, the substantially 
increased risk for diabetic ketoacidosis limits the use of this agent to a 
carefully selected subgroup of patients with T1DM. Based on the existing 
evidence, sotagliflozin should be considered only in patients who have failed to 
achieve adequate glycemic control despite optimal insulin therapy, are at low 
risk for diabetic ketoacidosis, have been adequately trained to recognize this 
complication and are able to be in close contact with their physician.