Diabetes mellitus type 2
Bydrueon BCise is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
The use of abbreviated pathways can reduce drug development costs so products can be offered at a lower price to patients.
The global Phase 3a clinical trial program for Ozempic comprised 8 clinical trials involving more than 8,000 adults with type 2 diabetes.
In clinical trials, treatment with Bydureon BCise resulted in average HbA1c reductions of up to 1.4% and average weight loss of up to 3.1 pounds when used as monotherapy or as an add-on to metormin, a sulfonylurea, a thiazolidinedione, or any combination of two of these agents, at 28 weeks.
The FDA Committee's positive recommendation was based on data from the global development program, SUSTAIN, which evaluated the safety and efficacy of once-weekly semaglutide.
Study authors analyzed the occurrence of amputation in patients with type 2 diabetes mellitus treated with SGLT2 inhibitors vs. non-SGLT2 inhibitors, and specifically, canagliflozin.
The American Diabetes Association (ADA) released its first position statement that includes detailed guidelines for psychosocial assessments and care based on factors including age, type of diabetes, and family support system.