Evidence map›Paper›PMID 31371432›Full record

Trial reportDiabetes care2019

The Impact of Sotagliflozin on Renal Function, Albuminuria, Blood Pressure, and Hematocrit in Adults With Type 1 Diabetes.

Daniël H van Raalte, Petter Bjornstad, Frederik Persson, David R Powell, Rita de Cassia Castro, Ping Stella Wang, Minzhi Liu, Hiddo J L Heerspink, David Cherney

Registry-linked trialOpen access · bronzeAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Diabetes care, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06217302 (Effectiveness and Safety of Sotagliflozin in Slowing Kidney Function Decline in Persons With Type 1 Diabetes and Moderate to Severe Diabetic Kidney Disease), which is not on this map. Cited by 49 papers, 8 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
49citing papers in PubMed, 8 pooled it
4.0field-weighted citation impact, top 5% 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.

NCT06217302 phase3recruitingnot on this mapstarted 2024, after this paper: background citation

Effectiveness and Safety of Sotagliflozin in Slowing Kidney Function Decline in Persons With Type 1 Diabetes and Moderate to Severe Diabetic Kidney Disease

TypeinterventionalSponsorAlessandro DoriaRan2024 to 2029Enrolled150ConditionsDiabetic Nephropathies, Kidney Failure, Chronic, Diabetes Mellitus Type 1, Heart FailureArmsSotagliflozin, Placebo
3 · Its place in the literature

Who cites it

49 citing papers in PubMed, 8 syntheses or guidelines pooled it, 82 citations in OpenAlex.

  1. Pooled it
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  7. Guideline
  8. Pooled it
  9. Trial
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  13. Article
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  15. Article
  16. Article
  17. Review
  18. Gliflozins in hypertension: basic mechanisms and clinical insights.American journal of physiology. Renal physiology · 2025
    Review
  19. Review
  20. 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

9 authors at 7 institutions in 5 countries.

Daniël H van RaalteDiabetes Center, Internal Medicine, Amsterdam UMC, Location VUmc, Amsterdam, the Netherlands.
Petter BjornstadDivision of Nephrology, Department of Medicine, and Section of Endocrinology, Department of Pediatrics, University of Colorado School of Medicine, Aurora, CO.ORCID 0000-0002-5160-2947
Frederik PerssonSteno Diabetes Center Copenhagen, Copenhagen, Denmark.
David R PowellLexicon Pharmaceuticals, Inc., The Woodlands, TX.
Rita de Cassia CastroSanofi, Bridgewater, NJ.
Ping Stella WangSanofi, Bridgewater, NJ.
Minzhi LiuSanofi, Bridgewater, NJ.
Hiddo J L HeerspinkThe George Institute for Global Health, Sydney, Australia.ORCID 0000-0002-3126-3730
David CherneyDivision of Nephrology, University of Toronto, Toronto, Canada david.cherney@uhn.ca.ORCID 0000-0003-4164-0429
Sanofi (United States) · USAmsterdam University Medical Centers · NLLexicon Pharmaceuticals (United States) · USSteno Diabetes Centers · DKUniversity of Colorado Denver · USUniversity of Groningen · NLUniversity of Toronto · CA

Funding

Renal HEIR Study: Renal Hemodynamics, Energetics and Insulin Resistance in Youth Onset Type 2 Diabetes StudyK23DK116720 · NIDDK · UNIVERSITY OF COLORADO DENVER · PI BJORNSTAD, PETTER · 2018 to 2022
$963k
NIDDK NIH HHS K23 DK116720
6 · The paper itself

Abstract

objectiveIn people with type 2 diabetes, sodium-glucose cotransporter 2 inhibitors (SGLT2i) reduce cardiovascular risk and progression of diabetic kidney disease. Our aim was to determine whether sotagliflozin (SOTA), a dual SGLT1i and SGLT2i, had favorable effects on clinical biomarkers suggestive of kidney protection in adults with type 1 diabetes. RESEARCH DESIGN AND

methodsIn this 52-week pooled analysis, 1,575 adults enrolled in the inTandem1 and inTandem2 trials were randomized to SOTA 200 mg, 400 mg, or placebo in addition to optimized insulin therapy. Changes in cardiorenal biomarkers were assessed.

resultsAt 52 weeks, in response to SOTA 200 and 400 mg, the placebo-corrected least squares mean change from baseline in estimated glomerular filtration rate was -2.0 mL/min/1.73 m

conclusionsSOTA was associated with short- and long-term renal hemodynamic changes, which were similar to those seen with SGLT2i in type 2 diabetes. Further investigation around cardiorenal effects of SOTA in people with type 1 diabetes is justified.

Indexed as

AdultAgedAlbuminuriaBlood PressureDiabetes Mellitus, Type 1Diabetic NephropathiesDrug Therapy, CombinationFemaleGlomerular Filtration RateGlycosidesHematocritHumansHypoglycemic AgentsInsulinKidneyMale(2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(methylthio)tetrahydro-2H-pyran-3,4,5-triolGlycosidesHypoglycemic AgentsInsulinSodium-Glucose Transporter 2 Inhibitors

Identifiers

PMID31371432
PMCPMC6905482
OpenAlexW2965440006

What OpenQuestion holds

Textmetadata
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 OpenQuestion graph.