Evidence map›Paper›PMID 31101403›Full record

Trial reportAmerican journal of kidney diseases : the official journal of the National Kidney Foundation2019

Safety and Effectiveness of Bexagliflozin in Patients With Type 2 Diabetes Mellitus and Stage 3a/3b CKD.

Andrew S Allegretti, Wenbin Zhang, Wenjiong Zhou, Tara K Thurber, Scott P Rigby, Cynthia Bowman-Stroud, Carlos Trescoli, Pierre Serusclat, Mason W Freeman, Yuan-Di C Halvorsen

Open access · greenAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in American journal of kidney diseases : the official journal of the National Kidney Foundation, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 42 papers, 19 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
42citing papers in PubMed, 19 pooled it
4.0field-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

42 citing papers in PubMed, 19 syntheses or guidelines pooled it, 81 citations in OpenAlex.

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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

10 authors at 3 institutions in 2 countries.

Andrew S AllegrettiDivision of Nephrology, Department of Medicine, Massachusetts General Hospital, Boston, MA. Electronic address: aallegretti@mgh.harvard.edu.
Wenbin ZhangTranslational Medicine Group, Center for Computational and Integrative Biology, Massachusetts General Hospital, Boston, MA; Shanghai JiaYue PharmaTech, Shanghai, China.
Wenjiong ZhouHopkins Consulting LLC, Philadelphia, PA.
Tara K ThurberTranslational Medicine Group, Center for Computational and Integrative Biology, Massachusetts General Hospital, Boston, MA.
Scott P RigbySummit Research Group/Unity Health Network, Munroe Falls, OH.
Cynthia Bowman-StroudFour Rivers Clinical Research, Paducah, KY.
Carlos TrescoliHospital Universitario de la Ribera, Valencia, Spain.
Pierre SerusclatGHM les Portes du Sud, Venissieux, France.
Mason W FreemanTranslational Medicine Group, Center for Computational and Integrative Biology, Massachusetts General Hospital, Boston, MA.
Yuan-Di C HalvorsenTranslational Medicine Group, Center for Computational and Integrative Biology, Massachusetts General Hospital, Boston, MA.
Massachusetts General Hospital · USHealth Net · USHospital de La Ribera · ES

Funding

PILOT AND FEASIBILITY (P/F) PROGRAMP30DK057521 · MASSACHUSETTS GENERAL HOSPITAL · 2000 to 2005
$8.2M
NIDDK NIH HHS P30 DK057521
6 · The paper itself

Abstract

RATIONALE &

objectiveHyperglycemia exacerbates the progression of chronic kidney disease (CKD), but most glucose-lowering therapies do not address morbidities associated with CKD. Sodium/glucose cotransporter 2 (SGLT2) inhibitors offer potential benefits to patients with diabetes and CKD, but their effectiveness may be diminished with decreased kidney function. We aimed to evaluate the safety and effectiveness of bexagliflozin, a novel SGLT2 inhibitor, in patients with type 2 diabetes and CKD. STUDY

designPhase 3, double-blind, placebo-controlled, multicenter, multinational, randomized trial. SETTING &

participants54 sites across 4 countries. Patients with CKD stage 3a or 3b, type 2 diabetes mellitus, and hemoglobin A

interventionsBexagliflozin, 20mg, daily versus placebo for 24 weeks. OUTCOMES: Primary outcome was change in percent hemoglobin A

results312 patients across 54 sites were analyzed. Bexagliflozin lowered hemoglobin A LIMITATIONS: Not designed to evaluate the impact of treatment on long-term kidney disease and cardiovascular outcomes.

conclusionsBexagliflozin reduces hemoglobin A

fundingTrial was sponsored by Theracos Sub, LLC.

Indexed as

AgedDiabetes Mellitus, Type 2Double-Blind MethodFemaleHumansMaleMiddle AgedPyransRenal Insufficiency, ChronicSeverity of Illness IndexSodium-Glucose Transporter 2 InhibitorsTreatment OutcomebexagliflozinPyransSodium-Glucose Transporter 2 Inhibitorsalbuminuriabexagliflozinchronic kidney disease (CKD)estimated glomerular filtration rate (eGFR)glucose-lowering therapyhemoglobin A(1c) (HbA(1c))kidney functionrandomized controlled trial (RCT)renal impairmentSGLT2 inhibitorType 2 diabetes

Identifiers

PMID31101403
PMCPMC10077840
OpenAlexW2945272854

What Socratic holds

Textmetadata
LicenceTDM
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 Socratic graph.