ADA 2023: Once Weekly (QW) Basal Insulin Fc (BIF) and Daily Degludec (DEG) Achieve Comparable Glycemic Control in Three Patient Populations Studied during Phase 2—Clinical Insights from CGM Assessments

BIF is a fusion protein that unites a novel single-chain insulin variant with a human IgG Fc domain. In three phase II studies, which were randomized, open-label, and treat-to-target, a total of 912 individuals with type 2 diabetes (previously treated with basal insulin- T2D-Switch, or new to insulin therapy- T2D-Naive) or type 1 diabetes (on multiple daily injections- T1D) were evaluated over a duration of 26 or 32 weeks. The studies assessed once-weekly (QW) BIF to once-daily degludec (DEG) and met the primary endpoint of non-inferiority in change in HbA1c from baseline (with a non-inferiority margin of 0.4%), and the key results were disclosed earlier. Two of the studies utilized continuous glucose monitoring (CGM) throughout the entire duration, while the T2D-Naïve study employed blinded, intermittent CGM sessions lasting 14 days each. At baseline, the patients' HbA1c levels were 8.1%, 8.0%, and 7.5% for T2D-Switch, T2D-Naïve, and T1D, respectively. The glucose profiles between the two treatments appeared similar, and the comparison of 24-hour average glucose levels for BIF versus DEG in T2D-Naïve: 137 vs 127 mg/dL p=.042 and T1D: 175 vs 169 p=.075 (T2D-Switch not available). The average duration of hypoglycemia (glucose levels below 70 mg/dL) per patient showed the following comparisons for BIF versus DEG: T2D-Switch 31 minutes vs. 35 minutes (p-value not statistically significant), T2D-Naïve 51 minutes vs. 91 minutes (p-value <0.001), and T1D 35 minutes vs. 35 minutes (p-value not statistically significant). In summary, the results indicate that QW BIF achieved comparable glycemic control to DEG, as evidenced by several CGM-derived measures.

806-P.American Diabetes Association (ADA) 83rd Scientific Sessions, 23rd-26th June 2023, San Diego, CA.