Evidence map›Paper›PMID 36944059›Full record

Trial reportDiabetes care2023

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, Christof M Kazda, Chenchen Ma, Jenny Chien, Qianyi Zhang, Emmanuel Chigutsa, William Landschulz, Axel Haupt, Juan P Frias

Open access · bronzeAbstract readRandomized Controlled TrialClinical Trial, Phase II
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 33 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
33citing papers in PubMed, 7 pooled it
10.7field-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

33 citing papers in PubMed, 7 syntheses or guidelines pooled it, 54 citations in OpenAlex.

  1. Pooled it
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  16. 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
    Article
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

9 authors at 2 institutions in 1 country.

Juliana M Bue-Valleskey1Eli Lilly and Company, Indianapolis, IN.ORCID 0000-0002-9746-7744
Christof M Kazda2Lilly France, Neuilly sur Seine, France.
Chenchen Ma1Eli Lilly and Company, Indianapolis, IN.
Jenny Chien1Eli Lilly and Company, Indianapolis, IN.
Qianyi Zhang1Eli Lilly and Company, Indianapolis, IN.
Emmanuel Chigutsa1Eli Lilly and Company, Indianapolis, IN.
William Landschulz1Eli Lilly and Company, Indianapolis, IN.
Axel Haupt1Eli Lilly and Company, Indianapolis, IN.
Juan P Frias3Velocity Clinical Research, Los Angeles, CA.
Eli Lilly (United States) · USVelocity Clinical Research (United States) · US

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 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

methodsDuring 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.

resultsAfter 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.

conclusionsOnce-weekly BIF achieved excellent glycemic control similar to degludec, with no concerning hypoglycemia or other safety findings.

Indexed as

Diabetes Mellitus, Type 2HypoglycemiaBlood GlucoseGlucoseGlycated HemoglobinGlycemic ControlHumansHypoglycemic AgentsInsulinInsulin GlargineInsulin, Long-ActingInsulin, Regular, HumanBlood GlucoseGlucoseGlycated HemoglobinHypoglycemic AgentsInsulininsulin degludecInsulin GlargineInsulin, Long-ActingInsulin, Regular, Human

Identifiers

PMID36944059
PMCPMC10154646
OpenAlexW4328051692

What OpenQuestion 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 OpenQuestion graph.