Evidence map›Paper›PMID 29669938›Full record

Trial reportJCI insight2018

Canagliflozin triggers the FGF23/1,25-dihydroxyvitamin D/PTH axis in healthy volunteers in a randomized crossover study.

Jenny E Blau, Viviana Bauman, Ellen M Conway, Paolo Piaggi, Mary F Walter, Elizabeth C Wright, Shanna Bernstein, Amber B Courville, Michael T Collins, Kristina I Rother and 1 more

2 registry-linked trialsOpen access · goldAbstract readComparative StudyRandomized Controlled Trial
In one paragraph

Trial report in JCI insight, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It reports registered trial NCT02891954. Cited by 101 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
101citing papers in PubMed, 6 pooled it
10.6field-weighted citation impact, top 1% 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.

NCT02891954 phase1active not recruiting

Pharmacogenomics to Predict Responses to SGLT2 Inhibitors

Ran2016Enrolled700Registered outcomes7Posted comparisons0ConditionsDiabetes Mellitus, Type 2ArmsCanagliflozin
Open the trial in the graph
NCT02404870 phase1completednot on this map

Acute Effects of Canagliflozin, a Sodium Glucose Co-Transporter 2 (SGLT2) Inhibitor on Bone Metabolism in Healthy Volunteers

TypeinterventionalSponsorNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Ran2014 to 2019Enrolled67ConditionsHealthy VolunteersArmsPlacebo, Canagliflozin
3 · Its place in the literature

Who cites it

101 citing papers in PubMed, 6 syntheses or guidelines pooled it, 160 citations in OpenAlex.

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  20. The effects of elevated phosphate on the kidney - damaging the gatekeeper.Pflugers Archiv : European journal of physiology · 2026
    Review

41 more citing papers are in PubMed but not listed here.

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 4 institutions in 3 countries.

Jenny E BlauDiabetes, Endocrinology, and Obesity Branch, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), and.
Viviana BaumanDiabetes, Endocrinology, and Obesity Branch, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), and.
Ellen M ConwayDiabetes, Endocrinology, and Obesity Branch, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), and.
Paolo PiaggiObesity and Diabetes Clinical Research Section, NIDDK, NIH, Phoenix, Arizona, USA.
Mary F WalterDiabetes, Endocrinology, and Obesity Branch, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), and.
Elizabeth C WrightDiabetes, Endocrinology, and Obesity Branch, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), and.
Shanna BernsteinNutrition Department, Hatfield Clinical Research Center, and.
Amber B CourvilleNutrition Department, Hatfield Clinical Research Center, and.
Michael T CollinsSkeletal Clinical Studies Unit, Craniofacial and Skeletal Diseases Branch, National Institute of Dental and Craniofacial Research (NIDCR), NIH, Bethesda, Maryland, USA.
Kristina I RotherDiabetes, Endocrinology, and Obesity Branch, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), and.
Simeon I TaylorDiabetes, Endocrinology, and Obesity Branch, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), and.
National Institute of Diabetes and Digestive and Kidney Diseases · USDiabetes Australia · AUNational Institute of Dental and Craniofacial Research · USUniversity of Maryland, Baltimore · US

Funding

Skeletal Disorders and Mineral Homeostasis SectionZIADE000649 · NIDCR · NATIONAL INSTITUTE OF DENTAL & CRANIOFACIAL RESEARCH · PI COLLINS, MICHAEL · 2009 to 2025
$32.8M
Clinical Research and Assay SupportZICDK071006 · NIDDK · NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES · PI WALTER, MARY · 2009 to 2025
$20.6M
Research BaseP30DK072488 · NIDDK · UNIVERSITY OF MARYLAND BALTIMORE · PI MITCHELL, BRAXTON D, TAYLOR, SIMEON I. · 2005 to 2019
$17.3M
Hyperparathyroidism-- Etiology, Diagnosis And TreatmentZIADK043006 · NIDDK · NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES · PI JHA, SMITA · 2011 to 2025
$8.9M
Studies in Youths & Young Adults with Obesity & T2DM (07-DK-0115, 10-DK-0163)ZIADK047049 · NIDDK · NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES · PI REITMAN, MARC L · 2009 to 2019
$4.4M
Pharmacogenomics of SGLT2 inhibitors: Pilot & Feasibility StudyR21DK105401 · NIDDK · UNIVERSITY OF MARYLAND BALTIMORE · PI TAYLOR, SIMEON I. · 2015 to 2016
$422k
NIDDK NIH HHS P30 DK072488NIDDK NIH HHS R21 DK105401
6 · The paper itself

Abstract

backgroundSodium glucose cotransporter-2 (SGLT2) inhibitors are the most recently approved class of drugs for type 2 diabetes and provide both glycemic efficacy and cardiovascular risk reduction. A number of safety issues have been identified, including treatment-emergent bone fractures. To understand the overall clinical profile, these safety issues must be balanced against an attractive efficacy profile. Our study was designed to investigate pathophysiological mechanisms mediating treatment-emergent adverse effects on bone health.

methodsWe conducted a single-blind randomized crossover study in hospitalized healthy adults (n = 25) receiving either canagliflozin (300 mg/d) or placebo for 5 days. The primary end-point was the drug-induced change in AUC for plasma intact fibroblast growth factor 23 (FGF23) immunoactivity between 24 and 72 hours.

resultsCanagliflozin administration increased placebo-subtracted mean levels of serum phosphorus (+16%), plasma FGF23 (+20%), and plasma parathyroid hormone (PTH) (+25%), while decreasing the level of 1,25-dihydroxyvitamin D (-10%). There was substantial interindividual variation in the magnitude of each of these pharmacodynamic responses. The increase in plasma FGF23 was correlated with the increase in serum phosphorus, and the decrease in plasma 1,25-dihydroxyvitamin D was correlated with the increase in plasma FGF23.

conclusionsCanagliflozin induced a prompt increase in serum phosphorus, which triggers downstream changes in FGF23, 1,25-dihydroxyvitamin D, and PTH, with potential to exert adverse effects on bone health. These pharmacodynamic data provide a foundation for future research to elucidate pathophysiological mechanisms of adverse effects on bone health, with the objective of devising therapeutic strategies to mitigate the drug-associated fracture risk.

trial registrationClinicalTrial.gov (NCT02404870).

fundingSupported by the Intramural Program of NIDDK.

Indexed as

AdultCanagliflozinCross-Over StudiesDiabetes Mellitus, Type 2FemaleFibroblast Growth Factor-23Fibroblast Growth FactorsFractures, BoneHealthy VolunteersHumansMaleMiddle AgedParathyroid HormonePhosphorusPlacebosSodium-Glucose Transporter 2 Inhibitors1,25-dihydroxyvitamin DCanagliflozinFGF23 protein, humanFibroblast Growth Factor-23Fibroblast Growth FactorsParathyroid HormonePhosphorusPlacebosSodium-Glucose Transporter 2 InhibitorsVitamin DBone BiologyBone diseaseDiabetesEndocrinology

Identifiers

PMID29669938
PMCPMC5931122
OpenAlexW2799518691

What Socratic holds

Texttitle and abstract
Read underepoch 390

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 Socratic graph.