Evidence mapPaperPMID 36574199Full record

ArticleDiabetes therapy : research, treatment and education of diabetes and related disorders2023

Ease of Use of the iGlarLixi SoloStar Pen from the LixiLan ONE CAN Pen Sub-Study: Questionnaire Findings from People Living with Type 2 Diabetes and Their HealthCare Providers.

Jean-François Yale, Aude Roborel de Climens, Naresh Aggarwal, Terry Dex, Hertzel C Gerstein, Stewart Harris, Irene Hramiak, John Stewart, Lawrence A Leiter

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in Diabetes therapy : research, treatment and education of diabetes and related disorders, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03767543 (A Randomized, 26-week, Open-label, 2-treatment Arm, Parallel Group Multicenter Study Comparing the Efficacy and Safety of Insulin Glargine/Lixisenatide Fixed-ratio Combination), which is not on this 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, top 73% 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.

NCT03767543 phase3completednot on this map

A Randomized, 26-week, Open-label, 2-treatment Arm, Parallel Group Multicenter Study Comparing the Efficacy and Safety of Insulin Glargine/Lixisenatide Fixed-ratio Combination (Soliqua™) Titrated Using a Simple Titration Algorithm (One Unit Daily Adjustment) Compared With Insulin Glargine/Lixisenatide Fixed-ratio Combination (Soliqua™) Titrated by Weekly Adjustment in Patients With Type 2 Diabetes Mellitus (T2DM)

TypeinterventionalSponsorSanofiRan2019 to 2020Enrolled265ConditionsType 2 Diabetes MellitusArmsINSULIN GLARGINE/LIXISENATIDE HOE901/AVE0010
3 · Its place in the literature

Who cites it

0 citing papers in PubMed, 0 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

9 authors at 7 institutions in 3 countries.

Jean-François YaleDepartment of Medicine, McGill University Health Centre, 1001 Decarie, Montreal, QC, H4A3J1, Canada. jean-francois.yale@mcgill.ca.ORCID http://orcid.org/0000-0002-7833-9050
Aude Roborel de ClimensSanofi, Lyon, France.ORCID http://orcid.org/0000-0002-5065-2010
Naresh AggarwalAggarwal And Associates, Clinical Department of Clinical Research and Family Practice, Brampton, ON, Canada.
Terry DexDepartment of Medical Affairs, Sanofi, Bridgewater, NJ, USA.
Hertzel C GersteinDepartment of Medicine, McMaster University, Hamilton, ON, Canada.ORCID http://orcid.org/0000-0001-8072-2836
Stewart HarrisSchulich School of Medicine and Dentistry, Western University, London, ON, Canada.ORCID http://orcid.org/0000-0002-1794-6551
Irene HramiakDepartment of Medicine, Western University, London, ON, Canada.ORCID http://orcid.org/0000-0002-3032-5338
John StewartDepartment of Statistics, Sanofi, Laval, QC, Canada.
Lawrence A LeiterLi Ka Shing Knowledge Institute, St. Michael's Hospital, University of Toronto, Toronto, ON, Canada.ORCID http://orcid.org/0000-0002-1040-6229
Western University · CAMcGill University Health Centre · CAMcMaster University · CASanofi (Canada) · CASanofi (France) · FRSanofi (United States) · USSt. Michael's Hospital · CA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionFor people with type 2 diabetes mellitus who do not achieve glycated hemoglobin A1C targets after treatment with basal insulin therapies, additional therapy with a glucagon-like peptide-1 receptor agonist (GLP-1 RA) may be required. One option is to use a once-daily fixed-ratio combination (FRC) of basal insulin and a GLP-1 RA such as iGlarLixi (which is composed of insulin glargine 100 U/ml and lixisenatide). However, the ease of transitioning from basal insulin to an FRC has not been studied.

methodsThis sub-study of the LixiLan ONE CAN trial (NCT03767543) was conducted to assess the ease of transitioning from insulin glargine 100 U/ml to the FRC, iGlarLixi, using the iGlarLixi SoloStar

resultsOverall, 95.1% of patients reported that the iGlarLixi Solostar pen was "easy" or "very easy" to use. Similarly, 100% of HCPs reported that it was "easy" or "very easy" to train people to use the pen. Nearly all participants (97.5% of patients and 94% of HCPs) responded that they would recommend the iGlarLixi Solostar pen to others.

conclusionsThese results suggest that during the transition from insulin glargine 100 U/ml to iGlarLixi, there were no difficulties associated with using the iGlarLixi SoloStar pen injector regarding instruction for use by HCPs or actual use by the majority of patients. The results indicate a broad consensus between patients and HCPs on the relative simplicity of transitioning from self-administration of insulin glargine 100 U/ml to iGlarLixi.

trial registrationClinicalTrials.gov identifier, NCT03767543; Date of registration: December 6, 2018; Retrospectively registered.

Indexed as

Fixed-ratio combinationiGlarLixiInjectionInsulin glargine 100 U/mlQuestionnaireSoloStarType 2 diabetes

Identifiers

PMID36574199
PMCPMC9943797
OpenAlexW4312211549

What Socratic holds

Textmetadata
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Registered trials

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.