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Clinical Trial
. 2023 May 1;46(5):1060-1067.
doi: 10.2337/dc22-2396.

Once-Weekly Basal Insulin Fc Demonstrated Similar Glycemic Control to Once-Daily Insulin Degludec in Insulin-Naive Patients With Type 2 Diabetes: A Phase 2 Randomized Control Trial

Juliana M Bue-Valleskey  1 , Christof M Kazda  2 , Chenchen Ma  1 , Jenny Chien  1 , Qianyi Zhang  1 , Emmanuel Chigutsa  1 , William Landschulz  1 , Axel Haupt  1 , Juan P Frias  3
Affiliations
Clinical Trial

Once-Weekly Basal Insulin Fc Demonstrated Similar Glycemic Control to Once-Daily Insulin Degludec in Insulin-Naive Patients With Type 2 Diabetes: A Phase 2 Randomized Control Trial

Juliana M Bue-Valleskey 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 the safety and efficacy of BIF versus degludec in insulin-naive 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-naive patients with T2D were randomly assigned (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 end point was HbA1c change from baseline to week 26 (noninferiority margin 0.4%). Secondary end points included fasting blood glucose (FBG), six-point glucose profiles, and rate of hypoglycemia.

Results: After 26 weeks of treatment, BIF demonstrated a noninferior 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 events/patient/year, degludec 0.15 events/patient/year; 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.

Trial registration: ClinicalTrials.gov NCT04450394.

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Conflict of interest statement

Duality of Interest. J.M.B.-V., C.M.K., C.M., J.C., Q.Z., E.C., W.L., and A.H. are employees and shareholders of Eli Lilly and Company. J.P.F. declares research support from Akero, AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, 89bio, Eli Lilly and Company, Intercept, IONIS, Janssen, Madrigal, Metacrine, Merck, NorthSea Therapeutics, Novartis, Novo Nordisk, Oramed, Pfizer, Poxel, and Sanofi and participation in speakers bureaus of Eli Lilly and Company and Sanofi and advisory boards or as a consultant for Akero, Altimmune, Axcella Health, Becton Dickenson, Boehringer Ingelheim, Carmot Therapeutics, Echosens, 89bio, Eli Lilly and Company, Gilead, Intercept, Metacrine, Merck, Novo Nordisk, Pfizer, and Sanofi. 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; inset shows estimated treatment difference (ETD) (90% CI) at 26 weeks. B: FBG over the course of the 26-week treatment period; inset shows estimated treatment difference (90% CI) at 26 weeks. Data are least squares mean ± SE. Δ, change from baseline.
Figure 2
Figure 2
A: Glucose profile for six-point SMBG monitoring. Data are the least squares mean ± SE. B: TIR parameters for 24-h period collected from assessments performed at baseline and after 12 and 26 weeks of treatment. Data are least squares mean. CGM assessments at week 26 reflect ∼60% of the BIF group. *P < 0.1 for BIF vs. insulin degludec.
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Comment in

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