Evidence map›Paper›PMID 25852208›Full record

Trial reportDiabetes care2015

Dapagliflozin's Effects on Glycemia and Cardiovascular Risk Factors in High-Risk Patients With Type 2 Diabetes: A 24-Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study With a 28-Week Extension.

William T Cefalu, Lawrence A Leiter, Tjerk W A de Bruin, Ingrid Gause-Nilsson, Jennifer Sugg, Shamik J Parikh

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

Trial report in Diabetes care, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 92 papers, 41 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
92citing papers in PubMed, 41 pooled it
12.5field-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.

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

92 citing papers in PubMed, 41 syntheses or guidelines pooled it, 179 citations in OpenAlex.

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32 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

6 authors at 4 institutions in 4 countries.

William T CefaluPennington Biomedical Research Center, Louisiana State University, Baton Rouge, LA william.cefalu@pbrc.edu.
Lawrence A LeiterKeenan Research Center in the Li Ka Shing Knowledge Institute, St. Michael's Hospital, and Division of Endocrinology & Metabolism, University of Toronto, Toronto, Canada.
Tjerk W A de BruinAstraZeneca, Global Medicines Development, Gaithersburg, MD.
Ingrid Gause-NilssonAstraZeneca, Global Medicines Development, Mölndal, Sweden.
Jennifer SuggAstraZeneca, Global Medicines Development, Gaithersburg, MD.
Shamik J ParikhAstraZeneca, Global Medicines Development, Gaithersburg, MD.
AstraZeneca (United Kingdom) · GBAstraZeneca (Sweden) · SELouisiana State University · USUniversity of Toronto · CA

Funding

Louisiana Clinical and Translational Science CenterU54GM104940 · LSU PENNINGTON BIOMEDICAL RESEARCH CTR · 2025 to 2025
$3.9M
NIGMS NIH HHS 1-U54-GM-104940NIGMS NIH HHS U54 GM104940
6 · The paper itself

Abstract

objectiveTo assess the efficacy and safety of dapagliflozin, a selective sodium-glucose cotransporter 2 inhibitor, compared with placebo in patients with type 2 diabetes (T2D), documented pre-existing cardiovascular disease (CVD), and a history of hypertension. RESEARCH DESIGN AND

methodsPatients (N = 922) were randomized to receive 10 mg dapagliflozin or placebo in a double-blind trial for 24 weeks, followed by a 28-week extension period. In patients receiving insulin, the insulin dose was reduced by 25% at randomization. Patients were stratified by age, insulin use, and time from the most recent qualifying cardiovascular (CV) event. Co-primary end points were a change from baseline in hemoglobin A1c (HbA1c) and the proportion of patients achieving a combined reduction in HbA1c of ≥0.5% (5.5 mmol/mol), body weight (BW) of ≥3%, and systolic blood pressure (SBP) of ≥3 mmHg.

resultsAt 24 weeks, dapagliflozin significantly reduced HbA1c (-0.38% [-4.2 mmol/mol]) from baseline (8.18%) compared with a slight increase with placebo from baseline (8.08%) (0.08% [0.9 mmol/mol]). Significantly more patients met the three-item end point with treatment with dapagliflozin than with placebo (11.7% vs. 0.9%, respectively). Changes were maintained over 52 weeks. Although ∼42% of patients were ≥65 years old, similar results were observed in both age-stratified groups. Serious adverse events, hypoglycemia, urinary tract infections, and cardiac disorders were similar between groups. Adverse events of hypotension, dehydration, hypovolemia, genital infection, and renal failure or impairment occurred more often with dapagliflozin treatment.

conclusionsIn this study that evaluated T2D patients who were at high risk for future CVD events, dapagliflozin administration had significantly greater effects in reducing HbA1c, BW, and SBP, without adversely impacting CV safety when compared with placebo treatment.

Indexed as

Analysis of VarianceBenzhydryl CompoundsBlood GlucoseBlood PressureBody WeightDiabetes Mellitus, Type 2Diabetic AngiopathiesDouble-Blind MethodFemaleGlucosidesGlycated HemoglobinHumansHypoglycemiaHypoglycemic AgentsInsulinMaleBenzhydryl CompoundsBlood GlucosedapagliflozinGlucosidesGlycated HemoglobinHypoglycemic AgentsInsulin

Identifiers

PMID25852208
PMCPMC4831907
OpenAlexW2076506641

What Socratic holds

Textmetadata
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.