The EASE Phase 3 program included 2 double-blind, placebo-controlled trials investigating the efficacy and safety of empagliflozin as an adjunct to insulin therapy in adults with type 1 diabetes.
For this study, researchers conducted a randomized, double-blind, placebo-controlled Phase 2 trial (N=24) to assess the efficacy and safety of adding oral verapamil for 12 months to a standard insulin regimen in adults with recent-onset type 1 diabetes (age range: 18 to 45 years).
Systemic shift in glucose metabolism from oxidative phosphorylation to aerobic glycolysis
The NDA was supported by data from the Phase 3 inTandem clinical trial program which assessed the safety and efficacy of Zynquista in ~3000 adults with inadequately controlled type 1 diabetes.
Increased time in the near normoglycemic range and reduced time in hypo- and hyperglycemia
Sotagliflozin is an investigational dual sodium-glucose co-transporter types 1 and 2 (SGLT1, SGLT2) inhibitor.
Both medications received approval from the FDA in 2017.
To address this issue, the Type 1 Diabetes Outcomes Program was launched to develop consensus definitions for a set of priority outcomes for T1D.
Researchers say new checklist can help determine when hypoglycemia should keep patients off the road
Thirty and 20 percent of participants, respectively, reported never and rarely checking ketones
