A new drug, sotagliflozi, has shown it could benefit people with type 1 diabetes as an add-on therapy to insulin.
Sotagliflozin has been developed by Lexicon Pharmaceuticals and is supported by Sanofi. The drug is a dual inhibitor of both sodium-glucose cotransporters 1 and 2 (SGLT-1 and SGLT-2). This marks a difference to currently available drugs Forxiga, Invokana and Jardiance which inhibit SGLT-2 alone.
The inTandem1 trial is a phase 3 clinical trial and involved 793 patients with type 1 diabetes in the USA and Canada. Before starting the study, the participants had higher than desired HbA1c levels of between 53 and 97 mmol/mol (7 and 11%).
Each of the participants were assigned to one of three arms. One arm took a 400mg dose of sotagliflozin once-daily, another arm took a 200mg dose of the drug each day and the third arm took a placebo pill.
Before the drug treatment started, patients’ insulin therapy was optimised, over a six-week period, which resulted in participants achieving an HbA1c of 60 mmol/mol (7.6%) across all three treatment arms.
The drug treatment part of the trial was 24 weeks long, and after this period, the different treatment arms demonstrated the following average reductions in HbA1c levels:
400mg dose: 5.4 mmol/mol (0.49%)
200mg dose: 4.7 mmol/mol (0.43%)
placebo: 0.9 mmol/mol (0.08%)
The lower dose of the drug (200mg) showed similar rates of adverse events as placebo. Rates of ketoacidosis were slightly higher compared with placebo (1.1% compared with 0%) whilst rates of severe hypoglycemia were lower for the 200mg sotagliflozin dose (4.2% compared with 4.6% for placebo).
The higher dose of the drug (400mg) increased the risk of adverse events with ketoacidosis 3.1% compared to placebo at 0% and severe hypoglycemia at 6.7% compared with placebo at 4.6%.
Lexicon is currently planning two more trials for people with type 1 diabetes, the inTandem2 and inTandem3 trials. A phase 3 trial to test the effects in people with type 2 diabetes is expected to commence before 2017.