Lexicon Pharmaceuticals announced positive pooled continuous glucose monitoring (CGM) data from the pivotal Phase 3 inTandem1 and inTandem2 studies of sotagliflozin, an investigational dual SGLT1 and SGLT2 inhibitor. At Week 24, patients treated with 200 mg and 400 mg doses of sotagliflozin spent a 5.4% and 11.7% greater proportion of the day, respectively, in the target glucose range of 70-180 mg/dL than those taking placebo, which translated into an additional 1.3 hours and 2.8 hours in a 24-hour period, respectively. These results were statistically significant (p=0.026 and p<0.001, respectively) and clinically meaningful for both doses of sotagliflozin.
"We are very pleased with today's results, which have important implications for the clinical management of glycemic control in patients with type 1 diabetes," said Paul Strumph, M.D., Lexicon's vice president of clinical research and development who leads the development program for sotagliflozin and has been living with type 1 diabetes for more than 50 years. "Every 1% increase in time in target glucose range of 70-180 mg/dL corresponds to up to 15 minutes a day not spent in hypo- or hyperglycemia. We believe that these highly favorable results represent an important key indicator of glucose control in addition to A1C reduction, and will be highly meaningful for patients as they seek to maintain glucose control throughout each day."
Discovered using Lexicon's unique approach to gene science, sotagliflozin is an investigational first-in-class, oral dual inhibitor of two proteins responsible for glucose regulation known as sodium-glucose co-transporter types 1 and 2 (SGLT1 and SGLT2). SGLT1 is responsible for glucose absorption in the gastrointestinal tract, and SGLT2 is responsible for glucose reabsorption by the kidney.