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.

Autor:	Bue-Valleskey JM; 1Eli Lilly and Company, Indianapolis, IN., Kazda CM; 2Lilly France, Neuilly sur Seine, France., Ma C; 1Eli Lilly and Company, Indianapolis, IN., Chien J; 1Eli Lilly and Company, Indianapolis, IN., Zhang Q; 1Eli Lilly and Company, Indianapolis, IN., Chigutsa E; 1Eli Lilly and Company, Indianapolis, IN., Landschulz W; 1Eli Lilly and Company, Indianapolis, IN., Haupt A; 1Eli Lilly and Company, Indianapolis, IN., Frias JP; 3Velocity Clinical Research, Los Angeles, CA.
Jazyk:	angličtina
Zdroj:	Diabetes care [Diabetes Care] 2023 May 01; Vol. 46 (5), pp. 1060-1067.
DOI:	10.2337/dc22-2396
Abstrakt:	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. (© 2023 by the American Diabetes Association.)
Databáze:	MEDLINE
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