Evidence map›Paper›PMID 29947099›Full record

Trial reportDiabetes, obesity & metabolism2018

Efficacy and safety of dapagliflozin or dapagliflozin plus saxagliptin versus glimepiride as add-on to metformin in patients with type 2 diabetes.

Dirk Müller-Wieland, Monika Kellerer, Katarzyna Cypryk, Dasa Skripova, Katja Rohwedder, Eva Johnsson, Ricardo Garcia-Sanchez, Raisa Kurlyandskaya, C David Sjöström, Stephan Jacob and 3 more

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IVMulticenter 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. It reports registered trial NCT02471404. Cited by 29 papers, 12 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
29citing papers in PubMed, 12 pooled it
5.4field-weighted citation impact, top 3% 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.

NCT02471404 phase4completed

A 52-Week, Multi-Centre, Randomised, Parallel-Group, Double-Blind, Active Controlled, Phase IV Study to Evaluate the Safety and Efficacy of Dapagliflozin or Dapagliflozin Plus Saxagliptin Compared With Sulphonylurea All Given as Add-on Therapy to Metformin in Adult Patients With Type 2 Diabetes Who Have Inadequate Glycaemic Control on Metformin Monotherapy

Ran2015Enrolled939Registered outcomes6Posted comparisons10ConditionsInadequate Glycaemic Control, Type 2 Diabetes MellitusArmsdapagliflozin, Glimepiride, Placebo for dapagliflozin, Placebo for glimepiride, Placebo for saxagliptin
Open the trial in the graph
3 · Its place in the literature

Who cites it

29 citing papers in PubMed, 12 syntheses or guidelines pooled it, 73 citations in OpenAlex.

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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

13 authors at 10 institutions in 7 countries.

Dirk Müller-WielandDepartment of Medicine I, University Hospital Rheinisch-Westfälische Technische Hochschule Aachen, Aachen, Germany.ORCID 0000-0002-8807-6442
Monika KellererMarienhospital, Zentrum Innere Medizin I, Stuttgart, Germany.
Katarzyna CyprykDepartment of Internal Medicine and Diabetology, Medical University of Lodz, Lodz, Poland.
Dasa SkripovaOutpatient Clinic of Diabetes and Metabolism, DIAMEL, Trencin, Slovakia.
Katja RohwedderAstraZeneca, Wedel, Germany.
Eva JohnssonAstraZeneca Gothenburg, Mölndal, Sweden.
Ricardo Garcia-SanchezAstraZeneca, Gaithersburg, Maryland.
Raisa KurlyandskayaAstraZeneca Gothenburg, Mölndal, Sweden.
C David SjöströmAstraZeneca Gothenburg, Mölndal, Sweden.
Stephan JacobCardio-Metabolic Institute, Villingen-Schwenningen, Germany.
Jochen SeufertDivision of Endocrinology and Diabetology, Department of Medicine II, Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany.ORCID 0000-0001-5654-7310
Nalina DronamrajuAstraZeneca, Gaithersburg, Maryland.
Katalin CsomósCRU Hungary Kft, Miskolc, Hungary.
AstraZeneca (Sweden) · SEAstraZeneca (United States) · USAstraZeneca (United Kingdom) · GBDiabetes Australia · AUMarienhospital Stuttgart · DEMedical University of Lodz · PLNephrologisches Zentrum Villingen-Schwenningen · DERWTH Aachen University · DEUniversity of Freiburg · DEUniversity of Miskolc · HU

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo compare the efficacy and safety of dapagliflozin and dapagliflozin plus saxagliptin vs glimepiride as add-on to metformin in patients with type 2 diabetes. RESEARCH DESIGN AND

methodsThis 52-week, multicentre, double-blind, active-controlled study (NCT02471404) randomized (1:1:1) patients (n = 939; HbA1c 7.5%-10.5%) on metformin monotherapy (≥1500 mg/day) to add-on dapagliflozin 10 mg, dapagliflozin 10 mg plus saxagliptin 5 mg, or glimepiride 1 to 6 mg (titrated). The primary efficacy end point was change in HbA1c from baseline to Week 52.

resultsBaseline mean age, diabetes duration and HbA1c were 58.4 years, 7.0 years and 8.3%, respectively. Adjusted mean HbA1c change from baseline was -1.20% with dapagliflozin plus saxagliptin and -0.82% with dapagliflozin, vs -0.99% with glimepiride (mean dose at Week 52, 4.6 mg). Changes in body weight (-3.2 kg and -3.5 kg vs +1.8 kg) and systolic blood pressure (SBP; -6.4 mm Hg and -5.6 mm Hg vs -1.6 mm Hg) were significantly greater with dapagliflozin plus saxagliptin and dapagliflozin than with glimepiride. FPG decreased significantly with dapagliflozin plus saxagliptin compared with glimepiride (-2.1 mmol/L vs -1.5 mmol/L) and was similar with dapagliflozin (-1.6 mmol/L) compared with glimepiride. Confirmed incidence of hypoglycaemia was lower with dapagliflozin regimens than with glimepiride (0 and 1 vs 13 patients) and fewer patients required rescue. Genital infections were more frequent with dapagliflozin; other AE profiles were similar.

conclusionsDapagliflozin, saxagliptin and metformin improved glycaemic control compared with glimepiride plus metformin; add-on of dapagliflozin alone showed efficacy similar to that of glimepiride. Both dapagliflozin regimens decreased body weight and SBP, with a lower incidence of hypoglycaemia compared with glimepiride.

Indexed as

AdamantaneAdultAgedBenzhydryl CompoundsBlood GlucoseDiabetes Mellitus, Type 2DipeptidesDouble-Blind MethodDrug Therapy, CombinationFemaleGlucosidesHumansMaleMetforminMiddle AgedSulfonylurea CompoundsAdamantaneBenzhydryl CompoundsBlood GlucosedapagliflozinDipeptidesglimepirideGlucosidesMetforminsaxagliptinSulfonylurea CompoundsdapagliflozinDPP-IV inhibitorphase III studySGLT2 inhibitorsulphonylureastype 2 diabetes

Identifiers

PMID29947099
PMCPMC6220756
OpenAlexW2810092615

What Socratic holds

Texttitle and abstract
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.