Evidence map›Paper›PMID 20566676›Full record

Trial reportDiabetes care2010

Dapagliflozin monotherapy in type 2 diabetic patients with inadequate glycemic control by diet and exercise: a randomized, double-blind, placebo-controlled, phase 3 trial.

Ele Ferrannini, Silvia Jimenez Ramos, Afshin Salsali, Weihua Tang, James F List

5 registry-linked trialsOpen access · bronzeAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Diabetes care, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It reports registered trial NCT00528372. Cited by 293 papers, 32 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
293citing papers in PubMed, 32 pooled it
27.6field-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.

NCT00528372 phase3completed

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Phase 3 Trial to Evaluate the Safety and Efficacy of Dapagliflozin as Monotherapy in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control With Diet and Exercise

Ran2007Enrolled1,067Registered outcomes17Posted comparisons54ConditionsType 2 DiabetesArmsdapagliflozin, Dapagliflozin placebo, Metformin
PMID 25381876other papers from this trial
Open the trial in the graph
NCT02113241 phase2 / phase3completedstarted 2014, after this paper: background citation

Effect of Dapagliflozin Administration on Metabolic Syndrome, Insulin Sensitivity, and Insulin Secretion

Ran2014Enrolled24Registered outcomes24Posted comparisons48ConditionsMetabolic Syndrome XArmsdapagliflozin, Placebo
PMID 24463448PMID 23906445PMID 22238392PMID 24105299PMID 24130972PMID 23910664PMID 23668478PMID 23210765PMID 23194084PMID 22701099PMID 22446170PMID 20518806other papers from this trial
Open the trial in the graph
NCT02887677 phase4terminatedstarted 2016, after this paper: background citation

A Study of the Effects of Dapagliflozin on Ambulatory Aortic Pressure, Arterial Stiffness and Urine Albumin Excretion in Patients With Type 2 Diabetes

Ran2016Enrolled85Registered outcomes9Posted comparisons0ConditionsDiabetes MellitusArmsdapagliflozin, Placebo
PMID 22411919PMID 24919526PMID 24745924PMID 22673021PMID 8366922PMID 26623980PMID 25322847PMID 25319601PMID 25230708PMID 25126392PMID 25054271PMID 24989141other papers from this trial
Open the trial in the graph
NCT05392959 phase4terminatedstarted 2022, after this paper: background citation

Effect of the Antidiabetic Drug DAPAgliflozin on the Coronary Macrovascular and MICROvascular Function in Type 2 Diabetic Patients

Ran2022Enrolled4Registered outcomes3Posted comparisons0ConditionsDiabetes Mellitus, Type 2ArmsDapagliflozin 10 mg Tab, Placebo
PMID 20609968PMID 25538310PMID 25488697PMID 28254770PMID 30415602PMID 30882238PMID 4808557PMID 7586302PMID 8124786PMID 8141866PMID 8462157PMID 8509531other papers from this trial
Open the trial in the graph
NCT01377844 phase2completednot on this mapstarted 2011, after this paper: background citation

Efficacy and Safety of EGT0001442 Compared With Placebo in Patients With Type 2 Diabetes Mellitus Inadequately Controlled by Diet and Exercise and up to One Oral Anti-diabetes Agent

TypeinterventionalSponsorTheracosRan2011 to 2013Enrolled288ConditionsDiabetes MellitusArmsEGT0001442, Placebo
3 · Its place in the literature

Who cites it

293 citing papers in PubMed, 32 syntheses or guidelines pooled it, 705 citations in OpenAlex.

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  13. American Association of Clinical Endocrinology Clinical Practice Guideline: Developing a Diabetes Mellitus Comprehensive Care Plan-2022 Update.Endocrine practice : official journal of the American College of Endocrinology and the American Association of Clinical Endocrinologists · 2022
    Guideline
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233 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

5 authors at 3 institutions in 3 countries.

Ele FerranniniDepartment of Internal Medicine, University of Pisa School of Medicine, Pisa, Italy. ferranni@ifc.cnr.it
Silvia Jimenez Ramos
Afshin Salsali
Weihua Tang
James F List
Bristol-Myers Squibb (United States) · USHospital Civil de Guadalajara · MXUniversity of Pisa · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveDapagliflozin, a highly selective inhibitor of the renal sodium-glucose cotransporter-2, increases urinary excretion of glucose and lowers plasma glucose levels in an insulin-independent manner. We evaluated the efficacy and safety of dapagliflozin in treatment-naive patients with type 2 diabetes. RESEARCH DESIGN AND

methodsThis was a 24-week parallel-group, double-blind, placebo-controlled phase 3 trial. Patients with A1C 7.0-10% (n = 485) were randomly assigned to one of seven arms to receive once-daily placebo or 2.5, 5, or 10 mg dapagliflozin once daily in the morning (main cohort) or evening (exploratory cohort). Patients with A1C 10.1-12% (high-A1C exploratory cohort; n = 73) were randomly assigned 1:1 to receive blinded treatment with a morning dose of 5 or 10 mg/day dapagliflozin. The primary end point was change from baseline in A1C in the main cohort, statistically tested using an ANCOVA.

resultsIn the main cohort, mean A1C changes from baseline at week 24 were -0.23% with placebo and -0.58, -0.77 (P = 0.0005 vs. placebo), and -0.89% (P < 0.0001 vs. placebo) with 2.5, 5, and 10 mg dapagliflozin, respectively. Signs, symptoms, and other reports suggestive of urinary tract infections and genital infection were more frequently noted in the dapagliflozin arms. There were no major episodes of hypoglycemia. Data from exploratory cohorts were consistent with these results.

conclusionsDapagliflozin lowered hyperglycemia in treatment-naive patients with newly diagnosed type 2 diabetes. The near absence of hypoglycemia and an insulin-independent mechanism of action make dapagliflozin a unique addition to existing treatment options for type 2 diabetes.

Indexed as

Diet TherapyExercise TherapyBenzhydryl CompoundsDiabetes Mellitus, Type 2Double-Blind MethodGlucosidesGlycated HemoglobinHumansHypoglycemic AgentsPlacebosTreatment OutcomeBenzhydryl CompoundsdapagliflozinGlucosidesGlycated HemoglobinHypoglycemic AgentsPlacebos

Identifiers

PMID20566676
PMCPMC2945163
OpenAlexW2114276479

What Socratic holds

Textmetadata
LicenceCC BY-NC-ND
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.