A type 1 diabetes drug being codeveloped by Lexicon Pharmaceuticals and Sanofi could be the first oral treatment approved for the autoimmune disease following the release of promising Phase III clinical trial results. The inTandem3 study of sotagliflozin met its primary endpoint of being superior to the placebo on a measure of blood glucose, known as A1C, of less than seven percent.
The results of the trial were published in the New England Journal of Medicine, and presented at the European Association for the Study of Diabetes (EASD) 53rd annual meeting in Lisbon, Portugal.
“The clinically meaningful and statistically significant effects of sotagliflozin on glucose control (A1C) were achieved with a similar rate of severe hypoglycemia while reducing weight and blood pressure in hypertensive patients with type 1 diabetes,” said Dr. Satish Garg, lead investigator of inTandem3, Professor of Medicine and Pediatrics. “The combination of these effects provides a differentiated drug profile and the opportunity for sotagliflozin to transform the treatment paradigm as a novel oral adjunct to insulin therapy in this patient population.”
Lexicon reported that twice as many patients taking sotagliflozin responded to treatment, compared to the placebo. In addition, the treatment was found to be superior to the placebo on all secondary endpoints, including body weight and blood pressure.
“Managing type 1 diabetes can be very challenging for patients and their caregivers and as a clinician treating patients with this condition, these positive results bring promise for our ability to improve lives,” said Garg.
After 24 weeks of treatment, sotagliflozin also reduced the bolus insulin used by patients to control their condition by 3.9 IU per day, compared to 1.1 for patients given the placebo. This data, in addition to the favourable safety profile, suggests that sotagliflozin could be a beneficial add-on therapy to injected insulin for type 1 diabetes management.
“Despite treatment with insulin analogues, approximately 70% of patients with type 1 diabetes do not reach the desired glycemic A1C target of <7.0%,” said Juliana Oliveira, Vice President and Global Project Head for Sotagliflozin, Sanofi. “These outcomes further highlight the large unmet need for new oral medications that can be added to insulin, and publication of these results in the New England Journal of Medicine will increase awareness of this need.”
Sanofi is reportedly planning to file for global regulatory approval in early 2018.