Sotagliflozin is indicated 'as an adjunct to insulin therapy to improve glycaemic control in adults with type 1 diabetes mellitus with a body mass index (BMI) 27 kg/m2 or more, who have failed to achieve adequate glycaemic control despite optimal insulin therapy'.
Sotagliflozin should not be started in people with type 1 diabetes with a low insulin need. It should not be started in people with a glomerular filtration rate of less than 60 ml/min and should be stopped at a glomerular filtration rate persistently below 45 ml/min. Sotagliflozin should be initiated and supervised by a physician experienced in the management of type 1 diabetes mellitus. During treatment with sotagliflozin, insulin therapy should be continuously optimised to prevent ketosis and diabetic ketoacidosis, and the insulin dose should only be reduced to avoid hypoglycaemia.
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