Evidence map›Paper›PMID 34322967›Full record

Trial reportDiabetes, obesity & metabolism2021

Effect of insulin degludec versus insulin glargine U100 on time in range: SWITCH PRO, a crossover study of basal insulin-treated adults with type 2 diabetes and risk factors for hypoglycaemia.

Ronald M Goldenberg, Vanita R Aroda, Liana K Billings, A Sia Louise Christiansen, Anders Meller Donatsky, Ehsan Parvaresh Rizi, Gracjan Podgorski, Katarina Raslova, David C Klonoff, Richard M Bergenstal

Open access · hybridAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Diabetes, obesity & metabolism, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed, 2 pooled it
3.7field-weighted citation impact, top 6% 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

14 citing papers in PubMed, 2 syntheses or guidelines pooled it, 29 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Review
  5. Article
  6. Review
  7. Article
  8. Article
  9. Review
  10. Insulin degludec in pregestational diabetes: evidence and perspectives.Archives of medical sciences. Atherosclerotic diseases · 2024
    Article
  11. Article
  12. Article
  13. Correlation Between Time in Range and HbA1c in People with Type 2 Diabetes on Basal Insulin: Post Hoc Analysis of the SWITCH PRO Study.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2023
    Article
  14. Article
4 · The record

Corrections and comments

  • Commented on by
    2022
5 · Who and what money

Authors and funding

10 authors at 8 institutions in 5 countries.

Ronald M GoldenbergLMC Diabetes and Endocrinology, Concord, Ontario, Canada.ORCID 0000-0002-1788-3255
Vanita R ArodaDiabetes Clinical Research, Division of Endocrinology, Diabetes & Hypertension, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts, USA.ORCID 0000-0002-7706-4585
Liana K BillingsDepartment of Medicine, NorthShore University HealthSystem/University of Chicago Pritzker School of Medicine, Skokie, Illinois, USA.
A Sia Louise ChristiansenBiostatistics, Insulin & Devices, Novo Nordisk, Søborg, Denmark.
Anders Meller DonatskyMedical & Science, New Generation Insulins, Novo Nordisk, Søborg, Denmark.
Ehsan Parvaresh RiziGlobal Medical Affairs, Novo Nordisk, Søborg, Denmark.
Gracjan PodgorskiInternal Medicine, Greenacres Hospital, Port Elizabeth, South Africa.
Katarina RaslovaMetabolic Center Ltd, Bratislava, Slovakia.
David C KlonoffDiabetes Research Institute, Mills-Peninsula Medical Center, San Mateo, CA, USA.ORCID 0000-0002-0624-698X
Richard M BergenstalInternational Diabetes Center and HealthPartners Institute, Minneapolis, MN, USA.
Novo Nordisk (Denmark) · DKBrigham and Women's Hospital · USElizabeth Donkin Hospital · ZAHealthPartners · USInstitut des Maladies Métaboliques et Cardiovasculaires · FRLMC Diabetes & Endocrinology (Canada) · CAMills Peninsula Health Services · USNorthShore University HealthSystem · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsTo compare time in range (TIR) with use of insulin degludec U100 (degludec) versus insulin glargine U100 (glargine U100) in people with type 2 diabetes. MATERIALS AND

methodsWe conducted a randomized, crossover, multicentre trial comparing degludec and glargine U100 in basal insulin-treated adults with type 2 diabetes and ≥1 hypoglycaemia risk factor. There were two treatment periods, each with 16-week titration and 2-week maintenance phases (with evaluation of glucose using blinded professional continuous glucose monitoring). The once-weekly titration (target: 3.9-5.0 mmol/L) was based on pre-breakfast self-measured blood glucose. The primary endpoint was percentage of TIR (3.9─10.0 mmol/L). Secondary endpoints included overall and nocturnal percentage of time in tight glycaemic range (3.9-7.8 mmol/L), and mean glycated haemoglobin (HbA1c) and glucose levels.

resultsAt baseline, participants (n = 498) had a mean (SD) age of 62.8 (9.8) years, a diabetes duration of 15.1 (7.7) years and an HbA1c level of 59.6 (11.0) mmol/mol (7.6 [1.0]%). Noninferiority and superiority were confirmed for degludec versus glargine U100 for the primary endpoint, with a mean TIR of 72.1% for degludec versus 70.7% for glargine U100 (estimated treatment difference [ETD] 1.43% [95% confidence interval (CI): 0.12, 2.74; P = 0.03] or 20.6 min/d). Overall time in tight glycaemic range favoured degludec versus glargine U100 (ETD 1.5% [95% CI: 0.15, 2.89] or 21.9 min/d). Degludec also reduced nocturnal time below range (TBR; <3.9 mmol/L) compared with glargine U100 (ETD -0.88% [95% CI: -1.34, -0.42] or 12.7 min/night; post hoc) and significantly fewer nocturnal hypoglycaemic episodes of <3.0 mmol/L were observed.

conclusionsDegludec, compared with glargine U100, provided more TIR and time in tight glycaemic range, and reduced nocturnal TBR in insulin-treated people with type 2 diabetes.

Indexed as

Diabetes Mellitus, Type 2HypoglycemiaAdultBlood GlucoseBlood Glucose Self-MonitoringCross-Over StudiesGlycated HemoglobinHumansHypoglycemic AgentsInsulin GlargineInsulin, Long-ActingMiddle AgedRisk FactorsBlood GlucoseGlycated HemoglobinHypoglycemic Agentsinsulin degludecInsulin GlargineInsulin, Long-Actingbasal insulinsinsulin analoguesinsulin treatmentlong-acting basal insulinprofessional CGMtype 2

Identifiers

PMID34322967
PMCPMC9290717
OpenAlexW3186539542

What OpenQuestion holds

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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 OpenQuestion graph.