Weekly BIF as efficacious as degludec with lower incident hypoglycaemia in type 2 diabetes patients: Lancet
USA: Weekly basal insulin Fc (BIF) provided similar efficacy to degludec despite higher fasting glucose targets in the BIF groups, according to findings from a phase 2 study. Lower glucose variability and higher fasting glucose targets contribute to lower rates of hypoglycemia for BIF versus degludec.
The study's findings, published in The Lancet Diabetes & Endocrinology, support continued BIF development as a once-weekly insulin treatment for patients with diabetes.
The burden of daily basal insulin causes delays and hesitancy in initiating insulin therapy. Insulin efsitora alfa, or basal insulin Fc, designed for once-weekly administration, is a human IgG (immunoglobulin G) Fc domain. Juan Frias, Velocity Clinical Research, Los Angeles, CA, USA, and colleagues aimed to explore the efficacy and safety of BIF in type 2 diabetes patients treated previously with basal insulin in an open-label, randomized, phase 2, 32-week study.
The study was conducted across 44 sites in Puerto Rico, Mexico, and the USA, enrolling patients with type 2 diabetes. Adults aged ≥18 years treated with basal insulin and up to three oral antidiabetic medications were eligible. Patients were randomly assigned in the ratio of 1:1:1 to subcutaneous BIF -- BIF treatment group 1 (BIF-A1) or 2 (BIF-A2) or insulin degludec. Different fasting glucose targets were selected for the BIF-A1, BIF-A2, and degludec groups. Patients assigned to BIF received a one-time loading dose of 1·5–3 times their calculated weekly dose. The first weekly dose was administered one week after the loading dose.
The efficacy analysis set comprised data from all randomized study participants who received at least one dose of the study medication. Participants were analyzed as per the treatment they were assigned. Changes in HbA1c from baseline to week 32 were the primary measure of glycemic control for BIF. Also, BIF was compared with degludec.
The authors reported the following findings:
· 399 participants were enrolled between 2018 to 2020 and randomized; 135 to BIF-A1, 132 to BIF-A2, or 132 degludec; 51% were female, and 49% were male.
· 379 were analysed for the primary outcome (130 in BIF-A1; 125 in BIF-A2: n=125; 124 in degludec).
· Mean change in HbA1c from baseline to week 32 (primary outcome) was –0·6% for BIF-A1 and BIF-A2. Degludec achieved a change from a baseline of –0·7%.
· The pooled BIF analysis showed non-inferiority compared to degludec for the treatment difference in HbA1c (0·1%).
· In the BIF groups, the hypoglycaemia (≤3·9 mmol/L) event rates defined as hypoglycaemia events per patient per year were 25% lower versus the degludec group (treatment ratio BIF-A1 versus degludec was 0·75, and BIF-A2 versus degludec was 0·74).
· Basal insulin Fc was well tolerated; treatment-emergent adverse events were comparable across groups.
"Our findings support continued BIF development as a once-weekly insulin treatment for patients with diabetes," the researchers concluded.
Reference:
The study, "Safety and efficacy of once-weekly basal insulin Fc in people with type 2 diabetes previously treated with basal insulin: a multicentre, open-label, randomized, phase 2 study", was published in The Lancet Diabetes & Endocrinology. DOI: https://doi.org/10.1016/S2213-8587(22)00388-6
