Evidence mapPaperPMID 35623748Full record

ArticleBMJ open2022

Real-world evidence on the use of a fixed-ratio combination of insulin glargine and lixisenatide (iGlarLixi) in people with suboptimally controlled type 2 diabetes in Romania: a prospective cohort study (STAR.Ro).

Cornelia Bala, Anca Cerghizan, Bogdan-Mircea Mihai, Mihaela Moise, Cristian Guja

Open access · goldAbstract read
In one paragraph

Article in BMJ open, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed
2.9field-weighted citation impact, top 8% 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

15 citing papers in PubMed, 21 citations in OpenAlex.

  1. Article
  2. Review
  3. Observational
  4. Review
  5. Observational
  6. Article
  7. The Current and Future Role of Insulin Therapy in the Management of Type 2 Diabetes: A Narrative Review.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2024
    Review
  8. Review
  9. Article
  10. Review
  11. Clinical Benefits of Treating Patients with Type 2 Diabetes Mellitus with iGlarLixi: A Patient-Level Simulation Study.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2023
    Article
  12. Effectiveness and Safety of iGlarLixi in People with Type 2 Diabetes in Adriatic Region Countries: ENSURE-ADR, a Real-World Study.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2023
    Article
  13. Article
  14. Article
  15. Review
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

5 authors at 2 institutions in 3 countries.

Cornelia Bala *Department of Diabetes, Nutrition and Metabolic Diseases, Iuliu Hațieganu University of Medicine and Pharmacy, Cluj-Napoca, Romania cbala@umfcluj.ro.
Anca Cerghizan *Clinical Center of Diabetes, Nutrition and Metabolic Diseases, County Clinical Emergency Hospital, Cluj-Napoca, Romania.
Bogdan-Mircea Mihai *Department of Diabetes, Nutrition and Metabolic Diseases, Grigore T Popa University of Medicine and Pharmacy Faculty of Medicine, Iasi, Romania.
Mihaela Moise *Sanofi Romania, Bucuresti, Romania.
Cristian Guja *Department of Diabetes, Nutrition and Metabolic Diseases, Carol Davila University of Medicine and Pharmacy, Bucuresti, Romania.
Diabetes Australia · AUClinical Emergency Hospital Bucharest · RO

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesTo assess the effectiveness and safety of insulin glargine and lixisenatide (iGlarLixi) fixed-ratio combination on a cohort of Romanian adults with type 2 diabetes (T2D).

designOpen-label, 24-week, prospective cohort study.

setting65 secondary care diabetes centres in Romania.

participantsThe study included 901 adults with T2D suboptimally controlled with previous oral antidiabetic drugs (OADs)±basal insulin (BI) who initiated treatment with iGlarLixi upon the decision of the investigator. Major exclusion criteria were iGlarLixi contraindications and refusal to participate. 876 subjects received at least one dose of iGlarLixi (intention-to-treat/safety population). PRIMARY AND SECONDARY OUTCOME MEASURES: The primary endpoint was change in glycated haemoglobin (HbA1c) from baseline to week 24 in the modified intention-to-treat population (study participants with HbA1c available at baseline and week 24). Secondary efficacy outcomes were percentage of participants reaching HbA1c targets and change in fasting plasma glucose (FPG).

resultsMean baseline HbA1c was 9.2% (SD 1.4) and FPG was 10.8 mmol/L (2.9). Mean HbA1c change was -1.3% (95% CI: -1.4% to -1.2%, p<0.0001) at week 24. HbA1c levels ≤6.5%, <7% and<7.5% at week 24 were achieved by 72 (8.9%), 183 (22.6%) and 342 (42.3%) participants, respectively. Mean FPG change was -3.1 mmol/L (95% CI: -3.3 to -2.8, p<0.001) at week 24. Mean body weight change was -1.6 kg (95% CI: -1.9 to -1.3, p<0.001) at 24 weeks. Mean iGlarLixi dose increased from 19.5 U (SD 7.7) and 30.1 U (10.0) to 30.2 U (8.9) (ratio 2/1 pen) and 45.0 U (11.6) (ratio 3/1 pen). Adverse events (AEs) were reported by 43 (4.9%) participants (18 (2.1%) gastrointestinal) with 4 (0.5%) reporting serious AEs. 13 (1.5%) participants reported at least one event of symptomatic hypoglycaemia, with one episode of severe hypoglycaemia reported.

conclusionsIn a real-world setting, 24-week treatment with iGlarLixi provided a significant reduction of HbA1c with body weight loss and low hypoglycaemia risk in T2D suboptimally controlled with OADs±BI treatment.

Indexed as

Diabetes Mellitus, Type 2Insulin GlarginePeptidesAdultDrug CombinationsGlucagon-Like Peptide-2 ReceptorGlycated HemoglobinHumansHypoglycemiaHypoglycemic AgentsProspective StudiesRomaniaDrug CombinationsGlucagon-Like Peptide-2 ReceptorGlycated HemoglobinHypoglycemic AgentsInsulin GlarginelixisenatidePeptidesclinical pharmacologydiabetes & endocrinologygeneral diabetes

Identifiers

PMID35623748
PMCPMC9150149
OpenAlexW4282004624

What Socratic holds

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LicenceCC BY-NC
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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.