Evidence map›Paper›PMID 22446170›Full record

Trial reportDiabetes care2012

Effects of dapagliflozin, an SGLT2 inhibitor, on HbA(1c), body weight, and hypoglycemia risk in patients with type 2 diabetes inadequately controlled on pioglitazone monotherapy.

Julio Rosenstock, Marisa Vico, Li Wei, Afshin Salsali, James F List

4 registry-linked trialsOpen access · hybridAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Diabetes care, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 4 registered trials, which are not on this map. Cited by 155 papers, 30 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
155citing papers in PubMed, 30 pooled it
29.5field-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.

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 20566676PMID 20518806other papers from this trial
Open the trial in the graph
NCT02925559 phase4completedstarted 2016, after this paper: background citation

Effect of Anti-diabetic Drugs on Glycemic Variability. A Comparison Between Gliclazide MR (Modified Release) and Dapagliflozin on Glycemic Variability Measured by Continuous Glucose Monitoring (CGM) in Patients With Uncontrolled Type 2 Diabetes

Ran2016Enrolled135Registered outcomes9Posted comparisons0ConditionsDiabetes Mellitus, Type 2Armsdapagliflozin, Gliclazide MR
PMID 22809630PMID 23425012PMID 23170914PMID 23911013PMID 24144654PMID 22413962PMID 21816980PMID 22690846PMID 19261490PMID 21813293PMID 16609090PMID 22431673other papers from this trial
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NCT03968224 phase2 / phase3completedstarted 2018, after this paper: background citation

Effectiveness of the Treatment With Dapagliflozin and Metformin Compared to Metformin Monotherapy for Weight Loss on Diabetic and Prediabetic Patients With Obesity Class III

Ran2018Enrolled160Registered outcomes7Posted comparisons4ConditionsDiabetes Mellitus, Type 2, Obesity, Morbid, PrediabetesArmsDapagliflozin/Metformin, Metformin
PMID 27333994PMID 25015317PMID 30742570PMID 24144654PMID 26203064PMID 24919526PMID 22238392PMID 7623902PMID 11118008PMID 7623903PMID 24463454PMID 11975807other papers from this trial
Open the trial in the graph
NCT02304081 phase4completednot on this mapstarted 2015, after this paper: background citation

Effect of Saxagliptin in Addition to Dapagliflozin and Metformin on Insulin Resistance, Islet Cell Dysfunction, and Metabolic Control in Subjects With Type 2 Diabetes Mellitus on Previous Metformin Treatment

TypeinterventionalSponsorProf. Dr. Thomas ForstRan2015 to 2016Enrolled64ConditionsType2 Diabetes MellitusArmsSaxagliptin, Placebo for Saxagliptin
3 · Its place in the literature

Who cites it

155 citing papers in PubMed, 30 syntheses or guidelines pooled it, 401 citations in OpenAlex.

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95 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

5 authors at 2 institutions in 1 country.

Julio RosenstockDallas Diabetes and Endocrine Center at Medical City, Dallas, TX, USA. juliorosenstock@dallasdiabetes.com
Marisa Vico
Li Wei
Afshin Salsali
James F List
Bristol-Myers Squibb (United States) · USDallas Diabetes Research Center · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo examine the safety and efficacy of dapagliflozin, a sodium-glucose cotransporter-2 inhibitor, added on to pioglitazone in type 2 diabetes inadequately controlled on pioglitazone. RESEARCH DESIGN AND

methodsTreatment-naive patients or those receiving metformin, sulfonylurea, or thiazolidinedione entered a 10-week pioglitazone dose-optimization period with only pioglitazone. They were then randomized, along with patients previously receiving pioglitazone ≥30 mg, to 48 weeks of double-blind dapagliflozin 5 (n = 141) or 10 mg (n = 140) or placebo (n = 139) every day plus open-label pioglitazone. The primary objective compared HbA(1c) change from baseline with dapagliflozin plus pioglitazone versus placebo plus pioglitazone at week 24. Primary analysis was based on ANCOVA model using last observation carried forward; all remaining analyses used repeated-measures analysis.

resultsAt week 24, the mean reduction from baseline in HbA(1c) was -0.42% for placebo versus -0.82 and -0.97% for dapagliflozin 5 and 10 mg groups, respectively (P = 0.0007 and P < 0.0001 versus placebo). Patients receiving pioglitazone alone had greater weight gain (3 kg) than those receiving dapagliflozin plus pioglitazone (0.7-1.4 kg) at week 48. Through 48 weeks: hypoglycemia was rare; more events suggestive of genital infection were reported with dapagliflozin (8.6-9.2%) than placebo (2.9%); events suggestive of urinary tract infection showed no clear drug effect (5.0-8.5% for dapagliflozin and 7.9% for placebo); dapagliflozin plus pioglitazone groups had less edema (2.1-4.3%) compared with placebo plus pioglitazone (6.5%); and congestive heart failure and fractures were rare.

conclusionsIn patients with type 2 diabetes inadequately controlled on pioglitazone, the addition of dapagliflozin further reduced HbA(1c) levels and mitigated the pioglitazone-related weight gain without increasing hypoglycemia risk.

Indexed as

Sodium-Glucose Transporter 2 InhibitorsAdultBenzhydryl CompoundsBlood GlucoseBody WeightDiabetes Mellitus, Type 2Double-Blind MethodFemaleGlucosidesGlycated HemoglobinHumansHypoglycemiaHypoglycemic AgentsMaleMiddle AgedPioglitazoneBenzhydryl CompoundsBlood GlucosedapagliflozinGlucosidesGlycated HemoglobinHypoglycemic AgentsPioglitazoneSLC5A2 protein, humanSodium-Glucose Transporter 2Sodium-Glucose Transporter 2 InhibitorsThiazolidinediones

Identifiers

PMID22446170
PMCPMC3379599
OpenAlexW2123984464

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.