American Diabetes Association
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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

posted on 2023-03-21, 18:37 authored by Juliana M. Bue-Valleskey, Christof M. Kazda, Chenchen MaChenchen Ma, Jenny Chien, Qianyi Zhang, Emmanuel Chigutsa, William Landschulz, Axel Haupt, Juan P Frias



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.


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.


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


Eli Lilly and Company


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