The FDA has approved a new insulin glargine injection to control high blood sugar in adults with type 2 diabetes and adults and children with type 1 diabetes.
A release from the manufacturer notes that the approval came after several clinical studies, and as part of a “comprehensive analytical, preclinical, and clinical program,” which, “confirmed the PK/PD, efficacy, safety and immunogenicity” of the treatment when compared to a similar treatment option. The research program included the INSTRIDE 1 and 2 trials, where the primary endpoint was a change from baseline in HbA1c after 24 weeks and secondary endpoints, including change from baseline in fasting plasma glucose and device-related safety issues.
The Phase 3 INSTRIDE 2 trial included 560 patients. The mean change in HbA1c from baseline to week 24 was -0.60% (95% CI -0.78, -0.41) and -0.66% (95% CI -0.84, -0.48) for the treatment and the reference treatment respectively. The safety profile was similar for both treatments.
“The global INSTRIDE clinical trials have demonstrated no difference in safety, efficacy, and immunogenicity of Semglee in comparison to the reference product, Lantus, in type 1 and type 2 diabetes,” said Christine Hamacher, PhD, CEO & Managing Director of Biocon Biologics in the release. “Our goal is to enable access to patients in need of insulins, and we are working towards creating a patient ecosystem that helps in lowering co-morbidities and achieving overall cost savings for the healthcare system.”