Evidence map›Paper›PMID 34052987›Full record

Observational studyAdvances in therapy2021

Real-World Use of Insulin Glargine U100 and U300 in Insulin-Naïve Patients with Type 2 Diabetes Mellitus: DosInGlar Study.

Natalia Duque, Esther Artime, Irene Romera, Jeremie Lebrec, Silvia Díaz, Miriam Rubio, Antoni Sicras-Mainar, Enrique Carretero-Anibarro, Xavier Mundet, Juan J Gorgojo-Martínez and 1 more

Open access · hybridAbstract readObservational Study
In one paragraph

Observational study in Advances in therapy, 2021. 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
0.7field-weighted citation impact, top 28% 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, 6 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 2 institutions in 1 country.

Natalia DuqueDepartamento Médico, Lilly Alcobendas, Avda. de la Industria 30, Alcobendas, 28108, Madrid, Spain. duque_natalia@lilly.com.
Esther ArtimeDepartamento Médico, Lilly Alcobendas, Avda. de la Industria 30, Alcobendas, 28108, Madrid, Spain.
Irene RomeraDepartamento Médico, Lilly Alcobendas, Avda. de la Industria 30, Alcobendas, 28108, Madrid, Spain.
Jeremie LebrecHaaPACS GmbH, Schriesheim, Germany.
Silvia DíazDepartamento Médico, Lilly Alcobendas, Avda. de la Industria 30, Alcobendas, 28108, Madrid, Spain.
Miriam RubioDepartamento Médico, Lilly Alcobendas, Avda. de la Industria 30, Alcobendas, 28108, Madrid, Spain.
Antoni Sicras-MainarAtrys Health SA, Health Economics and Outcomes Research, Barcelona, Spain.
Enrique Carretero-AnibarroMedicina Familiar y Comunitaria, Unidad de Gestión Clínica Estepa, Sevilla, Spain.
Xavier MundetUniversitat Autonoma de Barcelona, Bellaterra, Spain.
Juan J Gorgojo-MartínezDepartment of Endocrinology and Nutrition, Hospital Universitario Fundación Alcorcón, Madrid, Spain.
Jesús ReviriegoDepartamento Médico, Lilly Alcobendas, Avda. de la Industria 30, Alcobendas, 28108, Madrid, Spain.
Hospital Universitario Fundación Alcorcón · ESUniversitat Autònoma de Barcelona · ES

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionIn the EDITION clinical trial programme, patients with type 2 diabetes mellitus (T2DM) receiving insulin glargine (IGlar) U300 required 10-15% more insulin than those receiving IGlar U100. This study sought to determine whether this difference was apparent in real-world practice.

methodsIn this observational, retrospective cohort study, electronic medical records in the Big-Pac® database (Real Life Data) relating to adult insulin-naïve patients with T2DM who initiated IGlar U100 or U300 treatment in Spain in 2016-2017 and remained on treatment for 18 months were selected. IGlar U100- and U300-treated patients were matched 1:1 (propensity score matching). The primary analysis compared changes from baseline in mean daily IGlar dose (U and U/kg) at 6 (± 2), 12 (± 2) and 18 (± 2) months between cohorts (paired t tests). Changes in glycated haemoglobin (HbA1c) and weight were analysed descriptively.

resultsThe IGlar U100 and U300 cohorts included 556 matched pairs (46.9% female) with the following mean (standard deviation) values at baseline, respectively: age 63.6 (12.8) versus 63.7 (11.9) years; years since diagnosis 9.5 (1.4) versus 9.5 (1.3); HbA1c 8.8 (1.3) versus 8.7 (1.5) %; weight 84.6 (16.9) versus 84.7 (17.1) kg. Mean IGlar dose at baseline was 0.19 U/kg/day (both cohorts). Patients receiving IGlar U300 showed a greater increase from baseline in IGlar dose at 6, 12 and 18 months [mean dose (U/kg/day) 5.1%, 10.3% and 12.8% greater, respectively, in IGlar U300-treated patients]. Mean HbA1c was 8.1% in both cohorts at 18 months. Mean (SD) weight at 18 months with IGlar U100 and IGlar300 was 86.8 (17.0) kg and 85.0 (17.1) kg, respectively.

conclusionIn real-world practice, insulin dose was significantly higher in IGlar U300-treated than U100-treated patients at 6, 12 and 18 months, with similar reductions in HbA1c. At equal IGlar price/unit in Spain, the increased dose requirements of IGlar U300 would result in higher costs.

Indexed as

Diabetes Mellitus, Type 2AdultBlood GlucoseFemaleGlycated HemoglobinHumansHypoglycemic AgentsInsulinInsulin GlargineMaleMiddle AgedRetrospective StudiesSpainBlood GlucoseGlycated HemoglobinHypoglycemic AgentsInsulinInsulin GlargineCostDoseGlycaemic controlInsulin glargineReal-world evidenceType 2 diabetes mellitusU100U300

Identifiers

PMID34052987
PMCPMC8280027
OpenAlexW3164515781

What Socratic 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 Socratic graph.