Once-Weekly Basal Insulin Fc Shows Promise in Phase 2 Trial

A once-weekly insulin injection shows promise at ENDO 2021 by demonstrating noninferiority to daily insulin degludec in its first in-human, outpatient trial.

A 32-week phase 2 trial in 399 patients with type 2 diabetes, results suggest patients receiving basal insulin Fc (BIF) saw a mean HbA1c improvement of 0.6% and these patients were able to achieve similar long-term blood glucose control to those receiving insulin degludec.

“These study results demonstrate that BIF has promise as a once-weekly basal insulin and could be an advancement in insulin therapy,” said Juan Frias, MD, the trial’s principal investigator and the medical director of the National Research Institute in San Diego, in a statement.

With an interest in assessing the safety and efficacy of BIF, which is a long-acting IgG Fc-fusion protein, the current study was designed to assess the novel agent against insulin degludec in a parallel arm trial in patients with diabetes previously treated with oral antidiabetic agents and basal insulin. The trial included 2 different dosing algorithms with 2 different fasting glucose targets (140 mg/dL or less and 120 mg/dL or less) compared against insulin degludec with a fasting glucose target of 100 mg/dL or less.

The 399-patient cohort had an average age of 60.2 years, a mean baseline HbA1c of 8.1%, and a mean duration of diabetes of 14.7 years. Upon analysis, investigators found both BIIF arms achieved noninferiority (margin=.4%) for the endpoint of HbA1c change from baseline to week 32. Investigators noted both BIF groups had a statistically significant smaller increase in body weight compared to insulin degludec from baseline to week 32.

Safety analyses indicated hypoglycemic events were not significantly different between the study arms. Investigators also noted treatment-related adverse events and serious adverse events were balanced across the study arms.

As part of our coverage of ENDO 2021, Endocrinology Network reached out to Frias to learn more about his perspective on data and key takeaways from the phase 2 trial for diabetes specialists.

This study, “Once Weekly Basal Insulin Fc (BIF) is Safe and Efficacious in Patients with Type 2 Diabetes Mellitus (T2DM) Previously Treated With Basal Insulin,” was presented virtually as part of ENDO 2021.