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Randomized Controlled Trial
. 2023 May 1;46(5):1052-1059.
doi: 10.2337/dc22-2395.

Novel Once-Weekly Basal Insulin Fc Achieved Similar Glycemic Control With a Safety Profile Comparable to Insulin Degludec in Patients With Type 1 Diabetes

Christof M Kazda  1 , Juliana M Bue-Valleskey  2 , Jenny Chien  2 , Qianyi Zhang  2 , Emmanuel Chigutsa  2 , William Landschulz  2 , Paula Wullenweber  2 , Axel Haupt  2 , Dominik Dahl  3
Affiliations
Randomized Controlled Trial

Novel Once-Weekly Basal Insulin Fc Achieved Similar Glycemic Control With a Safety Profile Comparable to Insulin Degludec in Patients With Type 1 Diabetes

Christof M Kazda et al. Diabetes Care. .

Abstract

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 265 patients with type 1 diabetes (T1D) using multiple daily injections.

Research design and methods: During this randomized, parallel, open-label study, patients with T1D were randomized (1:1) to receive BIF once weekly or degludec once daily over the 26-week treatment period. Both groups were titrated to a fasting glucose level of 80-100 mg/dL. The primary end point was HbA1c change from baseline to week 26 (noninferiority margin, 0.4%). Secondary end points included percent time in range (TIR) (70-180 mg/dL), continuous glucose monitoring (CGM) fasting glucose (FG) level, and rate of hypoglycemia.

Results: After 26 weeks, patients receiving BIF had noninferior HbA1c change from baseline versus those receiving degludec, with a statistically significant treatment difference of 0.17% (90% CI 0.01, 0.32; P = 0.07) favoring the comparator. Percent TIR was similar for patients in the BIF (56.1%) and degludec (58.9%; P = 0.112) groups at week 26. FG values were significantly higher for patients receiving BIF (158.8 mg/dL) versus degludec (143.2 mg/dL; P = 0.003). Rates of CGM-derived hypoglycemia were not statistically significantly different for BIF and degludec over 24 h for level 1 (P = 0.960) or level 2 (P = 0.517) hypoglycemia during the treatment period. Occurrence of serious adverse events was similar between the BIF and degludec groups.

Conclusions: Once-weekly BIF demonstrated noninferior glycemic control to once-daily degludec (treatment difference: 0.17% favoring degludec) and no difference in hypoglycemia or other safety findings in patients with T1D.

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Conflict of interest statement

Duality of Interest. C.M.K., J.M.B.-V., J.C., Q.Z., E.C., W.L., P.W., and A.H. are employees and shareholders of Eli Lilly and Company. D.D. has received personal fees from Eli Lilly and Company during the conduct of the study and personal fees from Afimmune, Novo Nordisk, Novartis, Boehringer Ingelheim, and Amgen outside of the submitted work. No other potential conflicts of interest relevant to this article were reported.

Figures

None
Graphical abstract
Figure 1
Figure 1
A: HbA1c levels over the course of the 26-week treatment period. B: Fasting glucose based on CGM over the course of the 26-week treatment period. C: Six-point CGM-based glucose profiles at baseline and week 26. Data are presented as LSM ± SE. *P < 0.1 for BIF vs. insulin degludec. DEG, degludec.
Figure 2
Figure 2
TIR parameters for 24-h period collected from assessments performed at baseline and after 12 and 26 weeks of treatment during the (A) daytime, (B) nighttime, and (C) 24-h period. Nighttime was defined as midnight to 0600. Data are presented as LSM ±SE. *P < 0.1 for BIF vs. insulin degludec; **P < 0.001 for BIF vs. insulin degludec.
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