Evidence map›Paper›PMID 35650350›Full record

ArticleDiabetes therapy : research, treatment and education of diabetes and related disorders2022

Efficacy, Safety, and Immunogenicity of Biosimilar Insulin Aspart Premix SAR341402 Mix 70/30 Compared with Originator Insulin Aspart Mix 70/30 in Adults with Diabetes (GEMELLI M): A Subgroup Analysis by Prior Type of Premix Insulin.

S R Aravind, Kiran P Singh, Liliia Mogylnytska, Alsu G Zalevskaya, Beata Matyjaszek-Matuszek, Karin Wernicke-Panten, My-Liên Nguyên-Pascal, Suzanne Pierre, Baerbel Rotthaeuser, Daniel Kramer and 1 more

Open access · goldAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Diabetes therapy : research, treatment and education of diabetes and related disorders, 2022. 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
0.3field-weighted citation impact, top 42% 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

0 citing papers in PubMed, 2 citations in OpenAlex.

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 at 7 institutions in 6 countries.

S R AravindDiabetes Care and Research Center, Diacon Hospital, Bangalore, India.
Kiran P SinghDepartment of Endocrinology, Fortis Hospital Mohali, Chandigarh, India.
Liliia MogylnytskaKhmelnytskyi Regional Hospital, Khmelnytskyi, Ukraine.
Alsu G ZalevskayaDepartment of Endocrinology, First Pavlov State Medical University, St. Petersburg, Russia.
Beata Matyjaszek-MatuszekDepartment of Endocrinology, Medical University of Lublin, Lublin, Poland.
Karin Wernicke-PantenSanofi, Frankfurt, Germany.
My-Liên Nguyên-PascalSanofi Research and Development, Chilly-Mazarin, France.
Suzanne PierreSanofi Research and Development, Chilly-Mazarin, France.
Baerbel RotthaeuserSanofi, Frankfurt, Germany.
Daniel KramerSanofi, Frankfurt, Germany.
Bhaswati MukherjeeSanofi, 54 Rue La Boétie, 75008, Paris, France. Bhaswati.Mukherjee@sanofi.com.ORCID http://orcid.org/0000-0002-7465-9225
Sanofi (France) · FRSanofi (Germany) · DEDiacon Hospital · INFirst Pavlov State Medical University of St. Petersburg · RUFortis Hospital · INKhmelnytskyi National University · UAMedical University of Lublin · PL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionWe compared the efficacy, safety, and immunogenicity of biosimilar insulin aspart premix SAR341402 Mix 70/30 (70% intermediate SAR341402 protamine and 30% rapid SAR341402 solution) (SAR

methodsThis phase 3, randomized, open-label, multinational, 26-week trial (GEMELLI M) enrolled 402 participants with type 1 or type 2 diabetes. At randomization, participants switched from their prestudy premix insulin NovoMix 30 (n = 341) or Humalog Mix 25/Liprolog Mix 25 (n = 61) to equivalent (1:1) doses of either SAR

resultsAt week 26, change from baseline in HbA1c (primary efficacy endpoint) was similar between SAR

conclusionsEfficacy, safety, and immunogenicity profiles of SAR

trial registrationEudraCT number 2017-000092-84.

Indexed as

Biosimilar insulinGEMELLI MInsulin aspart mixPremixSAR341402Subgroup by prior premix insulin

Identifiers

PMID35650350
PMCPMC9159382
OpenAlexW4281653829

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.