Evidence map›Paper›PMID 31903680›Full record

ArticleDiabetes, obesity & metabolism2020

Effectiveness and safety of insulin glargine 300 U/mL in insulin-naïve patients with type 2 diabetes after failure of oral therapy in a real-world setting.

Martin Pfohl, François R Jornayvaz, Andreas Fritsche, Stefan Pscherer, Helmut Anderten, Katrin Pegelow, Jochen Seufert

Abstract read
In one paragraph

Article in Diabetes, obesity & metabolism, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers.

0numbers the graph read from it
0cells of the map it votes in
11citing 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

11 citing papers in PubMed.

  1. Article
  2. Article
  3. Article
  4. Observational
  5. Article
  6. Observational
  7. Real-World Effectiveness and Safety of Insulin Glargine 300 U/mL in Insulin-Naïve People with Type 2 Diabetes: the ATOS Study.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2022
    Article
  8. Article
  9. Impact of Age on the Effectiveness and Safety of Insulin Glargine 300 U/mL: Results from the REALI European Pooled Data Analysis.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2021
    Article
  10. Article
  11. Real-World Effectiveness of Insulin Glargine 300 Initiation in Switzerland.Diabetes, metabolic syndrome and obesity : targets and therapy · 2020
    Article
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

7 authors.

Martin PfohlDepartment of Internal Medicine I, Evang. Bethesda-Hospital Duisburg, Duisburg, Germany.
François R JornayvazDepartment of Endocrinology, Diabetology, Hypertension and Nutrition, University Hospital of Geneva, Geneva, Switzerland.
Andreas FritscheDepartment of Internal Medicine IV, University of Tuebingen, Tuebingen, Germany.
Stefan PschererDepartment of Internal Medicine III, Sophien- and Hufeland-Hospital, Weimar, Germany.
Helmut AndertenJoint Practice Anderten-Krok & Partner, Hildesheim, Germany.
Katrin PegelowSanofi-Aventis Deutschland GmbH, Berlin, Germany.
Jochen SeufertDivision of Endocrinology and Diabetology, Department of Medicine II, Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg, Germany.ORCID 0000-0001-5654-7310

Funding

American Diabetes AssociationGerman Diabetes SocietySanofi-Aventis Deutschland GmbH
6 · The paper itself

Abstract

aimTo evaluate the effectiveness and safety of initiating basal insulin-supported oral therapy (BOT) with insulin glargine 300 U/mL (Gla-300) in patients with type 2 diabetes inadequately controlled on oral antidiabetic drugs (OADs). MATERIALS AND

methodsThis non-interventional, multi-centre, prospective 52-week study, conducted in Germany and Switzerland, documented patients with type 2 diabetes with an HbA1c of between 7.5% and 10.0%, currently treated with OADs, after the physician had decided to start a BOT regimen with Gla-300. The primary endpoint was the rate of achievement of the individualized predefined HbA1c target.

resultsOf 1748 patients included, 1153 comprised the full analysis set, of whom 721 completed documentation of 12 months of Gla-300 treatment. Twelve months after starting Gla-300, 49.9% achieved their individualized HbA1c target, and 61.1% achieved either their HbA1c target or a fasting plasma glucose (FPG) of ≤110 mg/dL. Mean HbA1c decreased by -1.22% ± 1.05% to 7.28% ± 0.92% and mean FPG by -51.5 (±48.63) mg/dl to 132.9 ± 33.0 mg/dL. Median duration of HbA1c target achievement was 341 days and probability to remain on target after 6 months was 81%. Hypoglycaemia incidence and rates remained low after 12 months of Gla-300 treatment; no severe or severe nocturnal hypoglycaemia was observed. Body weight remained unchanged.

conclusionsStarting a BOT regimen with Gla-300 allowed about 60% of 721 German and Swiss patients with inadequately controlled type 2 diabetes to achieve glycaemic control within 12 months in daily clinical practice. Glycaemic control was achieved without weight gain or increased risk of nocturnal or severe hypoglycaemia.

Indexed as

Diabetes Mellitus, Type 2Administration, OralDrug Therapy, CombinationGermanyGlycated HemoglobinHumansHypoglycemic AgentsInsulinInsulin GlargineProspective StudiesGlycated HemoglobinHypoglycemic AgentsInsulinInsulin Glargineglycaemic controlhypoglycaemiainsulin analoguesobservational studytype 2 diabetes

Identifiers

PMID31903680
PMCPMC7187365

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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 OpenQuestion graph.