FDA Committee Votes on Oral T1D Treatment Sotagliflozin
The FDA takes the advice of the panel into consideration when making decisions, however it is not bound by their recommendations.
Type 1 Diabetes
Hypoglycemia Following Antifungal Tx in Patient With Type 1 Diabetes
“This is the first report of decreased insulin requirements in a patient with T1DM correlating with micafungin administration,” noted the authors.
Ready-to-Use Glucagon Rescue Pen Under FDA Review for Severe Hypoglycemia Tx
The NDA included findings from multiple Phase 3 trials evaluating the safety, efficacy, and utility of the Xeris glucagon rescue pen auto-injector to treat severe hypoglycemia vs currently available glucagon emergency kits in children, adolescents, and adults with type 1 diabetes.
Positive Results for Empagliflozin in Type 1 Diabetes Trials
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.
Calcium Channel Blocker May Benefit Patients 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).
BCG Vaccine Tied to Reduced Hyperglycemia in Type 1 Diabetes
Systemic shift in glucose metabolism from oxidative phosphorylation to aerobic glycolysis
Oral T1D Treatment Zynquista to Be Reviewed by FDA
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.
Artificial Pancreas Treatment Efficacious for Type 1 Diabetes
Increased time in the near normoglycemic range and reduced time in hypo- and hyperglycemia
Sotagliflozin NDA Submitted to FDA for Type 1 Diabetes
Sotagliflozin is an investigational dual sodium-glucose co-transporter types 1 and 2 (SGLT1, SGLT2) inhibitor.
Ozempic, Fiasp Now Available for the Treatment of Diabetes
Both medications received approval from the FDA in 2017.
