Sotagliflozin is used as an adjunct to insulin therapy to improve glycaemic control in adults with type 1 diabetes mellitus who have a Body Mass Index (BMI) ≥27 kg/m² and who have not achieved adequate glycaemic control despite optimal insulin treatment.

Sotagliflozin is an orally administered dual inhibitor of SGLT1 and SGLT2. It improves glycaemic and metabolic control through a dual mechanism: inhibition of SGLT1 in the gastrointestinal tract and inhibition of SGLT2 in the proximal renal tubules. Inhibition of SGLT1 delays and reduces glucose absorption in the small intestine, leading to reduced and delayed postprandial hyperglycaemia. Inhibition of SGLT2 decreases renal glucose reabsorption, lowers the renal threshold for glucose, and increases urinary glucose excretion.

Sotagliflozin is administered by the oral route. The recommended dose is 200 mg sotagliflozin once daily before the first meal of the day. After at least three months, if additional glycaemic control is needed, in patients tolerating sotagliflozin 200 mg, the dose may be increased to 400 mg once daily.

Interaction studies in healthy volunteers showed that Sotagliflozin has no clinically relevant effect on the pharmacokinetics of metformin, metoprolol, midazolam, or oral contraceptives.
Insulin: Insulin may increase the risk of hypoglycaemia. When used together with Sotagliflozin, a lower dose of insulin may be required to reduce the risk of hypoglycaemia.

Hypersensitivity to Sotagliflozin or any of its excipients.

Common adverse effects include hypotension, renal impairment, hepatic impairment, genital mycotic infections, urinary tract infections, nausea, vomiting, abdominal pain, excessive thirst, fatigue, increased ketones in urine or blood (beta-hydroxybutyrate), difficulty breathing or rapid deep breathing, difficulty concentrating, confusion, and rapid weight loss.

There are no adequate data on the use of Sotagliflozin in pregnant women. No information is available regarding its excretion into human breast milk.

Hypotension: Before starting Sotagliflozin, volume status should be assessed and hypovolemia corrected in elderly patients, patients with renal impairment, low systolic blood pressure, or those taking diuretics, as the drug may cause intravascular volume depletion.

Renal Impairment: Renal function should be assessed before and during treatment. Initiation is not recommended if eGFR is less than 60 mL/min/1.73 m², and treatment should be discontinued if eGFR remains persistently below 45 mL/min/1.73 m².

Hepatic Impairment: Sotagliflozin is not recommended in patients with moderate to severe hepatic impairment due to increased drug exposure.

Genital Mycotic Infections: Patients should be monitored and treated appropriately if infections occur.

Urinary Tract Infections: Temporary discontinuation should be considered in cases of pyelonephritis or urosepsis.

Single or multiple doses up to 800 mg once daily were well tolerated in healthy volunteers. In case of overdose, supportive and symptomatic treatment should be provided according to the patient’s clinical condition. The removal of Sotagliflozin by hemodialysis has not been studied.

SGLT2 & SGLT1 Inhibitors

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