Evidence map›SGLT2 inhibitors × blood pressure›PMID 24919526›Full record

Trial reportDiabetes, obesity & metabolism2014

Durability of glycaemic efficacy over 2 years with dapagliflozin versus glipizide as add-on therapies in patients whose type 2 diabetes mellitus is inadequately controlled with metformin.

M A Nauck, S Del Prato, S Durán-García, K Rohwedder, A M Langkilde, J Sugg, S J Parikh

2 registry-linked trialsAbstract readComparative StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Diabetes, obesity & metabolism, 2014. The graph read 1 number from its abstract, feeding 2 cells of the map, but none could be read as for or against, so it casts no vote. It is linked to 2 registered trials, which are not on this map. Cited by 44 papers, 8 of them syntheses that pooled it.

1number the graph read from it
0cells of the map it votes in
44citing papers in PubMed, 8 pooled it
12.4field-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.

Read, but not usablea number the graph found but could not read as for or against

Blood pressurecomparator not stated · hypertension, obesityfeeds 2 cells of the map
Δ -5.10-5.70 to -4.40
Dapagliflozin produced sustained reductions in weight and systolic blood pressure, whereas glipizide increased weight and systolic blood pressure, giving 104-week dapagliflozin versus glipizide differences of -5.1 kg (95% CI: -5.7,-4.4) and -3.9 mmHg (95% CI: -6.1,-1.7), respectively.
FeedsSGLT2 inhibitors×blood pressureSulfonylureas & glinides×blood pressure

clause the extractor read what became the number

2 · Its place on the map

Where it lands on the map

Rows are treatments, columns are outcomes. The coloured squares are the cells this paper feeds, coloured by the vote it casts there. Click one to jump to what this paper adds to it.

supports the treatmentfavours the comparatorno clear differenceread, but no usable result
3 · What it changes

What it adds to each cell

For every cell the paper feeds: the belief in the claim with and without this paper, and this paper's estimate drawn against every other readable study in the cell. The ringed dot is this paper.

SGLT2 inhibitors×blood pressure

No readable resultOpen on the map →What to test next →

38 readable studies in this cell: 24 favour the treatment, 14 find no difference, 0 favour the comparator.

Belief with this paper
0.88established · 14 families support, 2 contradict · against placebo
Without itNot a counted family in this claim, so removing it changes nothing.
← favours the treatmentfavours the comparator →
0 · no effect
NCT010326294,330 enrolled · 2009
Δ -2.96-4.00 to -1.91
NCT011374742,996 enrolled · 2010
Δ -3.05-4.87 to -1.24
NCT011956622,245 enrolled · 2010
Δ -4.28-6.54 to -2.02
NCT011066771,284 enrolled · 2010
Δ -2.87-4.46 to -1.28
NCT020991101,233 enrolled · 2014
Δ -2.76-4.69 to -0.83
NCT018093271,186 enrolled · 2013
Δ -1.91-3.64 to -0.18
NCT02580591977 enrolled · 2015
Δ -2.10-3.90 to -0.20
NCT01042977964 enrolled · 2010
Δ -2.71-4.28 to -1.15
NCT03332771954 enrolled · 2017
Δ -4.18-6.70 to -1.65
NCT00984867833 enrolled · 2009
Δ -0.86-3.75 to 2.03
NCT03351478770 enrolled · 2017
Δ -2.05-4.87 to 0.76
NCT01137812756 enrolled · 2010
Δ -5.91-7.64 to -4.17

This paper's own estimate is on a different scale from the rest of the cell, so it is not drawn here.

Sulfonylureas & glinides×blood pressure

No readable resultOpen on the map →What to test next →

5 readable studies in this cell: 0 favour the treatment, 1 find no difference, 4 favour the comparator.

Belief with this paper
0.00contested · 0 families support, 3 contradict · head-to-head
Without itNot a counted family in this claim, so removing it changes nothing.
← favours the comparatorfavours the treatment →
0 · no effect
NCT03332771954 enrolled · 2017
Δ -4.18-6.70 to -1.65
NCT02033889621 enrolled · 2013
Δ -4.50-6.81 to -2.19
NCT02419612444 enrolled · 2015
Δ -3.60-6.30 to -1.00
NCT00770653305 enrolled · 2007
Δ -2.49-5.40 to 0.42
NCT02564926125 enrolled · 2016
Δ -6.81-11.0 to -2.64

This paper's own estimate is on a different scale from the rest of the cell, so it is not drawn here.

4 · 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.

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 24745924PMID 22673021PMID 8366922PMID 26623980PMID 25322847PMID 25319601PMID 25230708PMID 25126392PMID 25054271PMID 24989141PMID 24951310other papers from this trial
Open the trial in the graph
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 22238392PMID 7623902PMID 11118008PMID 7623903PMID 24463454PMID 11975807PMID 16219009other papers from this trial
Open the trial in the graph
5 · Its place in the literature

Who cites it

44 citing papers in PubMed, 8 syntheses or guidelines pooled it, 114 citations in OpenAlex.

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6 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

7 · Who and what money

Authors and funding

7 authors at 6 institutions in 6 countries.

M A NauckDiabetes Centre, Bad Lauterberg, Germany.
S Del Prato
S Durán-García
K Rohwedder
A M Langkilde
J Sugg
S J Parikh
AstraZeneca (United States) · USAstraZeneca (Germany) · DEAstraZeneca (Sweden) · SEDiabeteszentrum Bad Lauterberg · DEHospital Universitario de Valme · ESUniversity of Pisa · IT

Funding

No grant is acknowledged in the PubMed record.

8 · The paper itself

Abstract

The marked sentences are the ones the graph read a number from.

aimsTo assess the long-term glycaemic durability, safety and tolerability of dapagliflozin versus glipizide as add-on therapies in patients with type 2 diabetes inadequately controlled by metformin alone.

methodsThis was a 52-week, randomised, double-blind study of dapagliflozin (n = 406) versus glipizide (n = 408), uptitrated over 18 weeks according to tolerability and glycaemic response to a maximum of 10 and 20 mg/day, respectively, as add-on therapies to metformin (≥ 1500 mg/day) with a 156-week double-blind extension period. Data over 104 weeks are reported here.

resultsIn total, 53.1% of patients completed 104 weeks of treatment. After the greater initial decrease (0-18 weeks) in glycated haemoglobin (HbA1c) with glipizide, the 18-104-week HbA1c coefficient of failure (CoF) was lower with dapagliflozin (0.13%/year) than with glipizide (0.59%/year), resulting in significant dapagliflozin versus glipizide differences of -0.46%/year (95% CI -0.60,-0.33; p = 0.0001) for CoF and -0.18%(-2.0 mmol/mol) [95% CI -0.33(-3.6),-0.03(-0.3); p = 0.021] for 104-week HbA1c. Dapagliflozin produced sustained reductions in weight and systolic blood pressure, whereas glipizide increased weight and systolic blood pressure, giving 104-week dapagliflozin versus glipizide differences of -5.1 kg (95% CI: -5.7,-4.4) and -3.9 mmHg (95% CI: -6.1,-1.7), respectively. Over 104 weeks, the hypoglycaemia rate was 10-fold lower with dapagliflozin than with glipizide (4.2 vs. 45.8%), whereas patient proportions with events suggestive of genital infection and of urinary tract infection (UTI) were greater with dapagliflozin (14.8 and 13.5%, respectively) than with glipizide (2.9 and 9.1%, respectively).

conclusionsOver 2 years, compared with glipizide, dapagliflozin demonstrated greater glycaemic durability, sustained reductions in weight and systolic blood pressure and a low hypoglycaemia rate; however, genital infections and UTIs occurred more frequently.

Indexed as

Benzhydryl CompoundsBlood GlucoseBlood PressureBody WeightDiabetes Mellitus, Type 2Dose-Response Relationship, DrugDouble-Blind MethodDrug Therapy, CombinationFemaleGlipizideGlucosidesHumansHypoglycemiaHypoglycemic AgentsMaleMetforminBenzhydryl CompoundsBlood GlucosedapagliflozinGlipizideGlucosidesHypoglycemic AgentsMetforminphase III studyrandomised trialSGLT2 inhibitorsulphonylureastype 2 diabetesweight loss therapy

Identifiers

PMID24919526
OpenAlexW2065946881

What Socratic holds

Texttitle and abstract
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.