Once Weekly Basal Insulin Fc (BIF) Demonstrated Similar Glycemic Control to Once Daily Insulin Degludec in Insulin-naïve Patients with Type 2 Diabetes, A Phase 2 Randomized Control Trial

Objective

Basal Insulin Fc (BIF; insulin efsitora alfa; LY3209590), a fusion protein combining a novel single-chain insulin variant with a human IgG Fc domain, is designed for once weekly basal insulin administration. This Phase 2 study assessed safety and efficacy of BIF versus degludec in insulin-naïve patients with type 2 diabetes (T2D) previously treated with oral antihyperglycemic medications.

Research Design and Methods

During this randomized, parallel, open-label study, 278 insulin-naïve patients with T2D were randomized (1:1) to receive BIF once weekly or degludec once daily over the 26-week treatment period. Both groups were titrated to fasting glucose of 80-100 mg/dL (4.4 to <5.6 mmol/L). The primary endpoint was HbA1c change from baseline to Week 26 (non-inferiority margin=0.4%). Secondary endpoints included fasting blood glucose (FBG), 6-point glucose profiles, and rate of hypoglycemia.

Results

After 26 weeks of treatment, BIF demonstrated non-inferior HbA1c change from baseline versus degludec with a treatment difference of 0.06% (90% CI= -0.11, 0.24; p=0.56).. Both BIF and degludec treatment led to significant reductions in FBG from baseline; at Week 26 the between treatment difference for BIF versus degludec was 4.7 mg/dL [90% CI=0.1, 9.3]; p=0.09). The rate of Level 2 hypoglycemia was low and not significantly different between treatment groups (BIF=0.22; degludec=0.15 events/pt/yr; p=0.64); there was no severe hypoglycemia. The occurrence of treatment-emergent adverse events was also similar between BIF and degludec.

Conclusions

Once weekly BIF achieved excellent glycemic control similar to degludec with no concerning hypoglycemia or other safety findings.