Lexicon Pharmaceuticals has announced positive findings from its phase II trial investigating sotagliflozin as an add-on treatment for people with poorly-controlled type 1 diabetes.
Sotagliflozin is a dual inhibitor of both sodium-glucose cotransporters 1 and 2 (SGLT1 and SGLT2), developed by Lexicon and pharmaceutical firm Sanofi. SGLT1 controls glucose absorption in the gastrointestinal tract, while SGLT2 handles glucose reabsorption in the kidney.
In this phase II trial, the oral drug was tested to confirm dosage suitability in Lexicon’s phase III trial, which is set to continue in December.
Last month, the company said that results from its ongoing phase III trial found it could benefit people with type 1 diabetes as an add-on therapy to insulin by lowering HbA1c levels.
The trial involved 141 participants with type 1 diabetes who had HbA1c levels between 53 and 86 mmol/mol (7 and 10%) before treatment.
In phase II, which tested varying doses of sotagliflozin (75mg, 200mg and 400mg) against a placebo, the drug again demonstrated a statistically significant decline in blood sugar during the 12-week treatment: the mean HbA1c reductions from the beginning of the trial were 7, 9 and 8 mmol/mol (0.6, 0.8 and 0.7%) for the 75, 200 and 400mg doses, respectively.
Over the 12-week study, there were three events of ssevere hypoglycemia, with one event occurring in each of the dose arms and none in the placebo arm. There was one episode of ketoacidosis (DKA), which occurred in the 400mg dose arm, while two episodes of DKA occurred in one patient during the initial no-dose run-in period of the trial.
Lexicon EVP and CMO Dr. Pablo Lapuerta said: “We continue to be very encouraged about the potential benefits that sotagliflozin may bring to people with type 1 diabetes, especially given that we saw significant glycemic control benefits coupled with favourable results on important safety parameters in this trial.
“In addition, this study provided the first demonstration in the setting of type 1 diabetes of some of the important characteristics of sotagliflozin’s differentiated dual SGLT1 and SGLT2 mechanism of action.”
Lexicon anticipates results from inTandem2 – part of the phase III program – in December, while Sanofi expects to start phase III testing of sotagliflozin in type 2 diabetes this year.