Evidence map›Paper›PMID 39691304›Full record

ArticleResearch in pharmaceutical sciences2024

Efficacy, safety, and immunogenicity of recombinant insulin aspart (BioGenomics Limited) and NovoRapid

Sneha A Dongre, Gauri A Kulkarni, Akshay Mishra, Rutuja B Deshmane, Nameeta Sonar, Kanica Yashi, Damodar Thapa, Nikhil Ghade, Sachin M Kadoo, Archana R Krishnan and 1 more

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Article in Research in pharmaceutical sciences, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
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

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors.

Sneha A DongreClinical Research Department, BioGenomics Ltd., Maharastra, India.
Gauri A KulkarniClinical Research Department, BioGenomics Ltd., Maharastra, India.
Akshay MishraCell Biology Department, BioGenomics Ltd., Maharastra, India.
Rutuja B DeshmaneCell Biology Department, BioGenomics Ltd., Maharastra, India.
Nameeta SonarBioGenomics Ltd, Maharastra, India.
Kanica YashiBioGenomics Ltd, Maharastra, India.
Damodar ThapaMolecular Biology Department, BioGenomics Ltd., Maharastra, India.
Nikhil GhadeAnalytical Development, BioGenomics Ltd., Maharastra, India.
Sachin M KadooClinical Research Department, BioGenomics Ltd., Maharastra, India.
Archana R KrishnanBioGenomics Ltd, Maharastra, India.
Sanjay M SonarBioGenomics Ltd, Maharastra, India.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background and purpose: To compare the efficacy, safety, and immunogenicity of recombinant insulin aspart 100 U/mL manufactured by BioGenomics Limited (BGL-ASP) with innovator NovoRapid Experimental approach: This was a multicenter, open-label, randomized, parallel-group study in T2 DM patients, on premix human insulin therapy ± oral anti-diabetics. Besides self-monitored plasma glucose, fasting and post-prandial plasma glucose (FPG and PPG) were tested at baseline, week 12, and week 24. Anti-insulin aspart antibodies measured immunogenicity at 12 and 24 weeks. Findings/Results: 160 patients out of 320 patients randomly received BGL-ASP and the remaining patients received NovoRapid Conclusion and implications: BGL-ASP and NovoRapid

Indexed as

BiosimilarImmunogenicityInsulin aspartNovoRapid®Type 2 diabetes mellitus

Identifiers

PMID39691304
PMCPMC11648344

What Socratic holds

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LicenceCC BY-NC-SA
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Registered trials

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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.