Evidence map›Paper›PMID 29888547›Full record

Trial reportDiabetes, obesity & metabolism2018

Efficacy and safety of dapagliflozin in patients with type 2 diabetes and moderate renal impairment (chronic kidney disease stage 3A): The DERIVE Study.

Paola Fioretto, Stefano Del Prato, John B Buse, Ronald Goldenberg, Francesco Giorgino, Daniel Reyner, Anna Maria Langkilde, C David Sjöström, Peter Sartipy, DERIVE Study Investigators

Erratum issued Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Diabetes, obesity & metabolism, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It reports registered trial NCT02413398. Cited by 98 papers, 35 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
98citing papers in PubMed, 35 pooled it
13.2field-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.

NCT02413398 phase3completed

A Multicenter, Double-Blind, Placebo-Controlled, Parallel Group, Randomized, Phase III Study to Evaluate the Glycemic Efficacy and Renal Safety of Dapagliflozin in Patients With Type 2 Diabetes Mellitus and Moderate Renal Impairment (CKD 3A) Who Have Inadequate Glycemic Control.

Ran2015Enrolled321Registered outcomes4Posted comparisons4ConditionsType 2 Diabetes MellitusArmsDapagliflozin 10 mg, Matching Placebo for Dapagliflozin
Open the trial in the graph
3 · Its place in the literature

Who cites it

98 citing papers in PubMed, 35 syntheses or guidelines pooled it, 184 citations in OpenAlex.

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

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

10 authors at 8 institutions in 4 countries.

Paola FiorettoDepartment of Medicine, University of Padova, Padova, Italy.ORCID 0000-0003-3445-0387
Stefano Del PratoDepartment of Clinical & Experimental Medicine, University of Pisa, Pisa, Italy.ORCID 0000-0002-5388-0270
John B BuseDepartment of Medicine, University of North Carolina School of Medicine, Chapel Hill, North Carolina.
Ronald GoldenbergLMC Diabetes & Endocrinology, Thornhill, Canada.
Francesco GiorginoDepartment of Emergency and Organ Transplantation, University of Bari Aldo Moro, Bari, Italy.ORCID 0000-0001-7372-2678
Daniel ReynerAstraZeneca, Gaithersburg, Maryland.
Anna Maria LangkildeAstraZeneca, Gothenburg, Sweden.
C David SjöströmAstraZeneca, Gothenburg, Sweden.
Peter SartipyAstraZeneca, Gothenburg, Sweden.
DERIVE Study Investigators
AstraZeneca (Sweden) · SEAstraZeneca (United States) · USLMC Diabetes & Endocrinology (Canada) · CAUniversity of Bari Aldo Moro · ITUniversity of North Carolina at Chapel Hill · USUniversity of Padua · ITUniversity of Pisa · ITUniversity of Skövde · SE

Funding

Re-Entry Supplement: Investigation of Oral Microbial Enzymes for the Detection and Treatment of Periodontal DiseaseUL1TR002489 · NCATS · UNIV OF NORTH CAROLINA CHAPEL HILL · PI BUSE, JOHN BERNARD, SHAHEEN, NICHOLAS J · 2018 to 2022
$48.6M
North Carolina Translational & Clinical Sciences Institute (NC TraCS)UL1TR001111 · NCATS · UNIV OF NORTH CAROLINA CHAPEL HILL · PI BUSE, JOHN BERNARD, CAREY, TIMOTHY S · 2013 to 2017
$43.9M
NCATS NIH HHS UL1 TR001111NCATS NIH HHS UL1 TR002489NIH HHS UL1TR001111
6 · The paper itself

Abstract

aimsDapagliflozin is a selective inhibitor of sodium glucose co-transporter 2 (SGLT2). This study assessed the efficacy and safety of dapagliflozin 10 mg vs placebo in patients with type 2 diabetes (T2D) and moderate renal impairment (estimated glomerular filtration rate [eGFR], 45-59 mL/min/1.73 m MATERIALS AND

methodsIn this double-blind, parallel group, Phase 3 study (NCT02413398, clinicaltrials.gov) patients with inadequately controlled T2D (HbA1c 7.0%-11.0%) were randomized (1:1) to dapagliflozin 10 mg once daily (N = 160) or matching placebo (N = 161) for 24 weeks. Randomization was stratified by pre-enrolment glucose-lowering therapy. The primary endpoint was change from baseline in HbA1c at Week 24.

resultsAt Week 24, compared with placebo, dapagliflozin significantly decreased HbA1c (difference [95% CI], -0.34% [-0.53, -0.15]; P < 0.001), body weight (difference [95% CI], -1.25 kg [-1.90, -0.59]; P < 0.001), fasting plasma glucose (difference [95% CI], -0.9 mmol/L [-1.5, -0.4]; P = 0.001) and systolic blood pressure (difference [95% CI], -3.1 mm Hg [-6.3, 0.0]; P < 0.05). Decreases from baseline in eGFR were greater with dapagliflozin than placebo at Week 24 (-2.49 mL/min/1.73 m

conclusionsThe findings of this study (NCT02413398, clinicaltrials.gov) support the positive benefit/risk profile of dapagliflozin for the treatment of patients with T2D and CKD 3A.

Indexed as

AdolescentAdultAgedBenzhydryl CompoundsDiabetes Mellitus, Type 2Diabetic NephropathiesDouble-Blind MethodFemaleGlucosidesHumansMaleMiddle AgedRenal Insufficiency, ChronicSeverity of Illness IndexTreatment OutcomeYoung AdultBenzhydryl CompoundsdapagliflozinGlucosides

Identifiers

PMID29888547
PMCPMC6175614
OpenAlexW2807732548

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.