A novel once-weekly Basal Insulin Fc achieved similar glycaemic control with a comparable safety profile versus insulin degludec in patients with type 1 diabetes

 

Question Is once-weekly Basal Insulin Fc (BIF), a novel single-chain insulin variant with a human IgG2 Fc domain, as safe and efficacious as once-daily insulin degludec (iDeg) in patients with Type 1 Diabetes (T1D)?

Methodology This open-label, parallel trial enrolled patients with T1D who were using multiple daily insulin injections for a minimum of 3 months before screening. BIF was injected once-weekly for 26-weeks, and IDeg was injected once-daily. Both groups were titrated to fasting blood glucose levels ≤ 5.6 mmol/L (100mg/dL). The primary endpoint was HbA1c change from baseline to Week 26 (non-inferiority [NI] margin=0.4%).

Results Patients were randomised to BIF (N=139) or IDeg (N=126). The baseline characteristics were well balanced among treatment groups. The HbA1c change from baseline to Week 26 treatment difference for BIF versus IDeg was 1.9mmol/mol (0.17%; [90% CI =0.01, 0.32]; p=0.07, meeting the NI margin. No significant treatment differences in patient-reported Level 1 or Level 2 hypoglycaemia were observed; 3 severe events were reported (2 on IDeg and 1 on BIF). No significant treatment differences were noted in the occurrence of serious adverse events or in body weight gain from baseline to study endpoint (BIF (0.1kg) vs IDeg (0.5kg).

Conclusion Once-weekly BIF demonstrated similar glycaemic control versus once-daily IDeg with no difference in hypoglycaemia or other safety findings in patients with T1D. These findings support continued development of BIF in Phase 3.

Publication History

Article published online:
02 May 2023

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