Novel Once-Weekly Basal Insulin Fc Achieved Similar Glycemic Control With a Safety Profile Comparable to Insulin Degludec in Patients With Type 1 Diabetes
Open accessAbstract
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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Basal insulin Fc (insulin efsitora alfa) showed noninferiority in terms of glycaemic control and hypoglycaemia risk compared with degludec in a study of 266 adults with type 1 diabetes.
“Similarly, basal insulin Fc (also referred to as insulin efsitora alfa) showed noninferiority in terms of glycaemic control and hypoglycaemia risk compared with degludec in a study of 266 adults with type 1 diabetes.88”
From The future of type 1 diabetes therapy (2025) · cites this paper as [88]
The Abstract Results report noninferior HbA1c change with basal insulin Fc versus degludec, and no statistically significant difference in hypoglycemia rates; they do not report a noninferiority finding for hypoglycemia risk. The Results state that 266 adults with type 1 diabetes were randomized, although the Abstract describes 265 patients in the study. (LLM, conf=0.90)
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References 13 · Cited by 56
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- Authors
- Kazda, C. M., Bue-Valleskey, J. M., Chien, J., Zhang, Q., Chigutsa, E., Landschulz, W., Wullenweber, P., Haupt, A., & Dahl, D.
- Affiliations
- 1Lilly France, Neuilly sur Seine, France
- 2Eli Lilly and Company, Indianapolis, IN
- Eli Lilly (United States) (US)
- 3Gemeinschaftspraxis für Innere Medizin und Diabetologie, Hamburg, Germany
- Corresponding author
- Kazda, Christof M.
- Venue
- Diabetes Care
- Publisher
- American Diabetes Association
- Published
- 2023-03-15
- Volume
- 46
- Issue
- 5
- Pages
- 1052-1059
- ISSN
- 0149-5992 (ISSN-L)
- 1935-5548
- PMC
- PMC10154655
- OpenAlex
- W4324304840
- Cited by
- 56
- References
- 13
- Citations by year
- 2026: 3 · 2025: 18 · 2024: 26 · 2023: 9
- FWCI
- 11.49
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- Diabetes Care (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- Funders
- Eli Lilly and Company
- Topics
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Research
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Genetics › Diabetes and associated disorders
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Treatment and Management
- Keywords
- insulin degludec, type 1 diabetes, glycemic control, HbA1c, hypoglycemia, time in range, continuous glucose monitoring, non-inferiority, multiple daily insulin injections, safety profile, IgG Fc
- MeSH terms
- Insulin Glargine, Glycemic Control, Blood Glucose, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2, Glycated Hemoglobin, Humans, Hypoglycemia, Hypoglycemic Agents, Insulin, Blood Glucose Self-Monitoring, Insulin, Long-Acting
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