Diabetes is a chronic condition that requires lifelong management, and for people with type 2 diabetes, insulin therapy may become necessary over time. However, the burden of daily basal insulin injections can be daunting, leading to hesitation and delays in initiating insulin therapy. A novel once-weekly basal insulin, basal insulin Fc (BIF), has been developed to address this issue.
BIF is a fusion protein that combines a single-chain insulin variant with a human immunoglobulin G (IgG) Fc domain. In this study, the safety and efficacy of BIF were evaluated in people with type 2 diabetes who had previously been treated with basal insulin.
According to The Lancet, a once-weekly basal insulin treatment for people with type 2 diabetes is both safe and effective in a phase 2 study. The treatment, called basal insulin Fc (BIF), is a fusion protein consisting of a novel single-chain insulin variant and a human immunoglobulin G (IgG) Fc domain.
It was designed to reduce the burden of daily insulin injections and encourage earlier initiation of insulin therapy. The study enrolled 399 participants across 44 sites in the USA, Puerto Rico, and Mexico, all of whom had been previously treated with basal insulin and up to three oral antidiabetic medicines.
Participants were randomly assigned to subcutaneous administration of either BIF (BIF treatment group 1 [BIF-A1] or 2 [BIF-A2]) or insulin degludec. Different fasting glucose targets were selected for each group, with the BIF-A1 and A2 groups having higher targets than the degludec group.
The primary measure of glycaemic control was the change in HbA1c from baseline to week 32 for BIF, and BIF was compared with degludec (with a non-inferiority margin of 0.40%). The efficacy analysis set collected data from all randomized study participants who received at least one dose of the study medication. Participants were analyzed according to the treatment they were assigned.
The study showed that BIF achieved similar efficacy compared with degludec despite having higher fasting glucose targets in the BIF groups. Mean HbA1c change from baseline to week 32, the primary outcome, was –0.6% for BIF-A1 and BIF-A2, while degludec achieved a change from baseline of –0.7%.
The pooled BIF analysis achieved non-inferiority versus degludec for the treatment difference in HbA1c (0.1% [90% CI –0.1 to 0.3]). The hypoglycemia (≤3.9 mmol/L or ≤70 mg/dL) event rates in the BIF groups were 25% lower than those in the degludec group, with BIF-A1 vs. degludec having a treatment ratio of 0.75 [0.61–0.93], and BIF-A2 vs. degludec having a treatment ratio of 0.74 [0.58–0.94].
The study found that BIF was well tolerated, with treatment-emergent adverse events similar across groups. These findings support the continued development of BIF as a once-weekly insulin treatment for people with diabetes. The burden of daily basal insulins often causes hesitancy and delays in initiating insulin therapy, but BIF could potentially overcome these issues and encourage earlier treatment initiation.
The study’s positive results indicate that BIF has the potential to be a game-changing treatment for people with type 2 diabetes and could significantly improve their quality of life by reducing the burden of daily insulin injections and lowering the risk of hypoglycemia.
Overall, this phase 2 study provides strong evidence for the safety and efficacy of BIF as a once-weekly insulin treatment for people with type 2 diabetes who have been previously treated with basal insulin.
The study’s findings pave the way for further development of BIF. They could ultimately lead to a new era of insulin therapy that is more convenient, effective, and safe for people with type 2 diabetes.