Sanofi, Lexicon's sotagliflozin hits main goal of late-stage study in patients with type 1 diabetes

Lexicon Pharmaceuticals announced Friday that a Phase III study of sotagliflozin for the treatment of patients with type 1 diabetes on any background insulin therapy met its primary endpoint. CEO Lonnel Coats said the dual SGLT1 and SGLT2 inhibitor, which the company is developing with Sanofi, "is the first-ever oral anti-diabetic drug candidate to have achieved success in now three consecutive Phase III clinical trials in this population."

In September last year, Lexicon reported that the inTandem1 study investigating sotagliflozin in patients with type 1 diabetes met its primary endpoint, with the company later announcing that the inTandem2 trial of patients with type 1 diabetes on optimised insulin therapy also hit its main goal.

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Lexicon noted that the latest study, dubbed inTandem3, randomised 1402 patients with type 1 diabetes on continuous subcutaneous insulin infusion or multiple daily injection therapy, who had an A1C level entering the trial of between 7 percent and 11 percent, to receive once-daily sotagliflozin or placebo. The primary aim of the study was to demonstrate the superiority of sotagliflozin over placebo in the proportion of patients with glycosylated A1C less than 7 percent at week 24 and no episode of severe hypoglycaemia and no episode of diabetic ketoacidosis (DKA) after randomisation.

Results showed that the rate of severe hypoglycaemia in the sotagliflozin arm of the study was 3 percent, compared to 2.4 percent for placebo, while the rates of DKA in the two groups were 3 percent and 0.6 percent, respectively. Lexicon indicated that a full analysis of the data will be submitted for publication in a peer-reviewed journal.

Satish Garg, lead investigator of the inTandem3 study, called the findings "scientifically and clinically important and significant," adding that "if approved, sotagliflozin may potentially be the first option as an adjunct to insulin to improve glycaemic control for patients with type 1 diabetes."

Meanwhile, Jorge Insuasty, head of global development at Sanofi, remarked "we look forward to pursuing regulatory submissions for the treatment of type 1 worldwide and to continuing to study the use of sotagliflozin in adults with type 2 diabetes." Under a deal signed in 2015, Lexicon granted Sanofi a license to develop and commercialise sotagliflozin, with the French drugmaker responsible for all activities related to the development of the drug for the treatment of type 2 diabetes.

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