Evidence mapPaperPMID 39446459Full record

Trial reportThe Journal of clinical endocrinology and metabolism2025

Safety, Growth, and Development After Dapagliflozin or Saxagliptin in Children With Type 2 Diabetes (T2NOW Follow-Up).

Naim Shehadeh, Pietro Galassetti, Nayyar Iqbal, Cecilia Karlsson, John Monyak, Jennifer Ostridge, Marie Bolin, Timothy Barrett

Abstract readRandomized Controlled TrialClinical Trial, Phase IIIMulticenter Study
In one paragraph

Trial report in The Journal of clinical endocrinology and metabolism, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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

2 citing papers in PubMed.

  1. Review
  2. 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

8 authors.

Naim ShehadehAzrieli Faculty of Medicine, Bar-Ilan University, Safed, 1311502, Israel.
Pietro GalassettiLate-Stage Development, Cardiovascular, Renal, and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, MD 20878, USA.
Nayyar IqbalLate-Stage Development, Cardiovascular, Renal, and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, MD 20878, USA.
Cecilia KarlssonLate-Stage Development, Cardiovascular, Renal, and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, 43183, Sweden.ORCID 0000-0002-4299-8775
John MonyakLate-Stage Development, Cardiovascular, Renal, and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, MD 20878, USA.
Jennifer OstridgeLate-Stage Development, Cardiovascular, Renal, and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, 43183, Sweden.
Marie BolinLate-Stage Development, Cardiovascular, Renal, and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, 43183, Sweden.
Timothy BarrettDepartment of Cancer and Genomic Sciences, College of Medicine and Health, University of Birmingham, Birmingham B15 2TT, UK.ORCID 0000-0002-6873-0750

Funding

AstraZeneca
6 · The paper itself

Abstract

contextThe T2NOW trial of dapagliflozin or saxagliptin vs placebo in pediatric patients with type 2 diabetes (T2D) demonstrated promising efficacy data for dapagliflozin and did not raise any safety concerns over 52 weeks.

objectiveThis work aimed to assess long-term effects of prior dapagliflozin/saxagliptin administration on safety, growth, and development.

methodsA multicenter, randomized, double-blind phase 3 trial (T2NOW) was conducted among 210 children with T2D aged 10 to 17 years, followed for up to 1 year after treatment. Participants were previously treated with once-daily dapagliflozin (5, 10 mg), saxagliptin (2.5, 5 mg), or placebo as an add-on to diet, exercise, metformin, and/or insulin for 52 weeks, plus a 52-week nontreatment follow-up period. Main outcome measures included change in height, weight, body mass index (BMI), Tanner staging, growth and maturation markers, bone biomarkers, and adverse events (AEs) from baseline to week 104.

resultsAs expected in a pediatric population, mean height and weight slightly increased from baseline to week 104. BMI remained generally stable; changes were similar across treatment groups. Sexual maturation progressed normally to week 104, with similar shifts between Tanner stages and changes in growth and maturation markers and bone biomarkers across groups. The proportion of patients reporting 1 or more AEs during the nontreatment follow-up period was similar across groups previously treated with dapagliflozin (18.5%) or saxagliptin (15.9%) compared to placebo (21.1%). No deaths occurred.

conclusionPrior treatment with dapagliflozin or saxagliptin for 52 weeks did not raise any safety concerns relating to height, weight, BMI, Tanner staging, growth and maturation markers, bone biomarkers, or AEs for up to 52 weeks following treatment discontinuation in pediatric patients with T2D.

Indexed as

AdamantaneBenzhydryl CompoundsDiabetes Mellitus, Type 2DipeptidesGlucosidesHypoglycemic AgentsSodium-Glucose Transporter 2 InhibitorsAdolescentBody HeightBody Mass IndexBody WeightChildDipeptidyl-Peptidase IV InhibitorsDouble-Blind MethodFemaleFollow-Up StudiesAdamantaneBenzhydryl CompoundsdapagliflozinDipeptidesDipeptidyl-Peptidase IV InhibitorsGlucosidesHypoglycemic AgentssaxagliptinSodium-Glucose Transporter 2 InhibitorsdapagliflozinDPP4 inhibitorpediatricsaxagliptinSGLT2 inhibitortype 2 diabetes

Identifiers

PMID39446459
PMCPMC12086385

What Socratic holds

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LicenceCC BY
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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.