Evidence map›Paper›PMID 36920867›Full record

Trial reportDiabetes care2023

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, Juliana M Bue-Valleskey, Jenny Chien, Qianyi Zhang, Emmanuel Chigutsa, William Landschulz, Paula Wullenweber, Axel Haupt, Dominik Dahl

Open access · bronzeAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Diabetes care, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 27 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
27citing papers in PubMed, 5 pooled it
10.9field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

27 citing papers in PubMed, 5 syntheses or guidelines pooled it, 54 citations in OpenAlex.

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  14. Pharmacokinetic and Pharmacodynamic Properties of Once-Weekly Insulin Efsitora Alfa in Japanese Patients with Type 2 Diabetes.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2025
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

9 authors at 2 institutions in 2 countries.

Christof M Kazda1Lilly France, Neuilly sur Seine, France.
Juliana M Bue-Valleskey2Eli Lilly and Company, Indianapolis, IN.ORCID 0000-0002-9746-7744
Jenny Chien2Eli Lilly and Company, Indianapolis, IN.
Qianyi Zhang2Eli Lilly and Company, Indianapolis, IN.
Emmanuel Chigutsa2Eli Lilly and Company, Indianapolis, IN.
William Landschulz2Eli Lilly and Company, Indianapolis, IN.
Paula Wullenweber2Eli Lilly and Company, Indianapolis, IN.
Axel Haupt2Eli Lilly and Company, Indianapolis, IN.
Dominik Dahl3Gemeinschaftspraxis für Innere Medizin und Diabetologie, Hamburg, Germany.
Eli Lilly (United States) · USPraxis für Humangenetik · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveBasal 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

methodsDuring 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.

resultsAfter 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.

conclusionsOnce-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.

Indexed as

Diabetes Mellitus, Type 1Diabetes Mellitus, Type 2HypoglycemiaBlood GlucoseBlood Glucose Self-MonitoringGlycated HemoglobinGlycemic ControlHumansHypoglycemic AgentsInsulinInsulin GlargineInsulin, Long-ActingBlood GlucoseGlycated HemoglobinHypoglycemic AgentsInsulininsulin degludecInsulin GlargineInsulin, Long-Acting

Identifiers

PMID36920867
PMCPMC10154655
OpenAlexW4324304840

What Socratic holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.