Evidence map›Paper›PMID 31397845›Full record

Observational studyThe Journal of clinical endocrinology and metabolism2019

Switching to Degludec From Other Basal Insulins Is Associated With Reduced Hypoglycemia Rates: A Prospective Study.

Gian Paolo Fadini, Michael Feher, Troels Krarup Hansen, Harold W de Valk, Mette Marie Koefoed, Michael Wolden, Esther Zimmermann, Johan Jendle

Registry-linked trialAbstract readMulticenter StudyObservational Study
In one paragraph

Observational study in The Journal of clinical endocrinology and metabolism, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02392117 (A Multi-centre, Prospective, Non-interventional Study of Insulin Degludec Investigating the Safety and Effectiveness in a Real World Population With Type 1 and 2 Diabetes Mellitus), which is not on this map. Cited by 16 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed, 1 pooled it
–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.

NCT02392117 completednot on this map

A Multi-centre, Prospective, Non-interventional Study of Insulin Degludec Investigating the Safety and Effectiveness in a Real World Population With Type 1 and 2 Diabetes Mellitus

TypeobservationalSponsorNovo Nordisk A/SRan2015 to 2018Enrolled1,262ConditionsDiabetes, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2Armsinsulin degludec
3 · Its place in the literature

Who cites it

16 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. American Association of Clinical Endocrinology Clinical Practice Guideline: Developing a Diabetes Mellitus Comprehensive Care Plan-2022 Update.Endocrine practice : official journal of the American College of Endocrinology and the American Association of Clinical Endocrinologists · 2022
    Guideline
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  5. The Long-Term Cost-Effectiveness of Tirzepatide 5 mg versus Dulaglutide 0.75 mg for the Treatment of People with Type 2 Diabetes in Japan.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2025
    Article
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  7. Insulin Degludec in People with Type 2 Diabetes in China: A Non-interventional, Retrospective Chart Review Study (CN-TREAT).Diabetes therapy : research, treatment and education of diabetes and related disorders · 2024
    Article
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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

8 authors.

Gian Paolo FadiniDepartment of Medicine, Division of Metabolic Diseases, University of Padova, Padova, Italy.
Michael FeherBeta Cell Diabetes Centre, Chelsea and Westminster Hospital, London, United Kingdom.
Troels Krarup HansenSteno Diabetes Center Aarhus, Aarhus University Hospital, Aarhus, Denmark.
Harold W de ValkDepartment of Internal Medicine, University Medical Center Utrecht, CX Utrecht, Netherlands.
Mette Marie KoefoedNovo Nordisk A/S, Søborg, Denmark.
Michael WoldenNovo Nordisk A/S, Søborg, Denmark.
Esther ZimmermannNovo Nordisk A/S, Søborg, Denmark.
Johan JendleFaculty of Medicine and Health, School of Medical Sciences, Örebro University, Örebro, Sweden.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

contextObservational studies of insulin degludec (degludec) with hypoglycemia events prospectively recorded are lacking.

objectiveTo evaluate the safety and effectiveness of degludec in patients with type 1 diabetes (T1D) or type 2 diabetes (T2D) switching from other basal insulins in routine care.

designResults From Real-World Clinical Treatment With Tresiba® was a multinational, multicenter, prospective, observational, single-arm study comprising a 4-week baseline period (preswitch basal insulin) and 12-month follow-up (degludec).

settingRoutine clinical practice. PATIENTS OR OTHER

participantsInsulin-treated patients (≥18 years) with T1D (n = 556) or T2D (n = 611) with treatment plans to initiate degludec.

interventionsSwitching to degludec from other basal insulins.

main outcome measureChange from baseline in number of overall hypoglycemic events recorded in patient diaries.

resultsIn T1D, the 12-month follow-up/baseline rate ratios (95% CI) of overall [0.80 (0.74 to 0.88)], nonsevere [0.83 (0.76 to 0.91)], severe [0.28 (0.14 to 0.56)], and nocturnal [0.61 (0.50 to 0.73)] hypoglycemia suggested significantly lower hypoglycemia rates with degludec (all Ps < 0.001). At 12 months, HbA1c, fasting plasma glucose (FPG), and basal insulin dosage decreased significantly. Body weight increased, and treatment satisfaction improved significantly. In T2D, the hypoglycemia rate ratios were overall [0.46 (0.38 to 0.56)], nonsevere [0.53 (0.44 to 0.64)], and nocturnal [0.35 (0.20 to 0.62)] (all Ps < 0.001; too few events for analysis of severe hypoglycemia). At 12 months, HbA1c and FPG decreased significantly. Body weight and insulin dosages remained unchanged, and treatment satisfaction was significantly improved.

conclusionsIn a routine clinical care setting, switching to degludec from other basal insulins was associated with significantly lower rates of hypoglycemia, improved glycemic control, and treatment satisfaction in patients with T1D or T2D.

Indexed as

Drug SubstitutionAdultAgedBlood GlucoseDiabetes Mellitus, Type 1Diabetes Mellitus, Type 2EuropeFemaleFollow-Up StudiesGlycated HemoglobinHumansHypoglycemiaInsulin, Long-ActingInsulinsMaleMiddle AgedBlood GlucoseGlycated Hemoglobininsulin degludecInsulin, Long-ActingInsulins

Identifiers

PMID31397845
PMCPMC6812737

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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 OpenQuestion graph.