Evidence mapPaperPMID 29446523Full record

Trial reportDiabetes, obesity & metabolism2018

Safety and tolerability of dapagliflozin, saxagliptin and metformin in combination: Post-hoc analysis of concomitant add-on versus sequential add-on to metformin and of triple versus dual therapy with metformin.

Stefano Del Prato, Julio Rosenstock, Ricardo Garcia-Sanchez, Nayyar Iqbal, Lars Hansen, Eva Johnsson, Hungta Chen, Chantal Mathieu

Registry-linked trialOpen access · hybridAbstract readComparative StudyMulticenter StudyRandomized Controlled Trial
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 is linked to trial NCT04735042 (Use of Combination Empagliflozin/Linagliptin or Dapagliflozin/Saxagliptin vs Empagliflozin or Dapagliflozin Alone, Subclinical Inflammation of the Genito-urinary Tract and Risk of Infections.), which is not on this map. Cited by 15 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed, 2 pooled it
1.5field-weighted citation impact, top 17% 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.

NCT04735042 completedstarted 2020, after this paper: background citation

Use of Combination Empagliflozin/Linagliptin or Dapagliflozin/Saxagliptin vs Empagliflozin or Dapagliflozin Alone, Subclinical Inflammation of the Genito-urinary Tract and Risk of Infections.

Ran2020Enrolled60Registered outcomes9Posted comparisons0ConditionsType 2 Diabetes, Urinary Tract InfectionsArmsEmpagliflozin / Linagliptin or Dapagliflozin/Saxagliptin Pill, Empagliflozin or Dapagliflozin Pill
Open the trial in the graph
3 · Its place in the literature

Who cites it

15 citing papers in PubMed, 2 syntheses or guidelines pooled it, 26 citations in OpenAlex.

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  15. Clinical Use of DPP-4 Inhibitors.Frontiers in endocrinology · 2019
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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

8 authors at 6 institutions in 7 countries.

Stefano Del PratoDepartment of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy.ORCID 0000-0002-5388-0270
Julio RosenstockDallas Diabetes Research Center at Medical City, Dallas, Texas.ORCID 0000-0001-8324-3275
Ricardo Garcia-SanchezGlobal Medicines Development, AstraZeneca, Gaithersburg, Maryland.
Nayyar IqbalGlobal Medicines Development, AstraZeneca, Gaithersburg, Maryland.
Lars HansenGlobal Clinical Research Metabolics, Bristol-Myers Squibb, Princeton, New Jersey.ORCID 0000-0003-0784-8189
Eva JohnssonGlobal Medicines Development, AstraZeneca, Gothenburg, Sweden.
Hungta ChenGlobal Medicines Development, AstraZeneca, Gaithersburg, Maryland.
Chantal MathieuClinical and Experimental Endocrinology, University of Leuven, Leuven, Belgium.ORCID 0000-0002-4055-5233
AstraZeneca (Poland) · PLAstraZeneca (Netherlands) · NLBristol-Myers Squibb (Germany) · DEDallas Diabetes Research Center · USKU Leuven · BEUniversity of Pisa · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The safety of triple oral therapy with dapagliflozin plus saxagliptin plus metformin versus dual therapy with dapagliflozin or saxagliptin plus metformin was compared in a post-hoc analysis of 3 randomized trials of sequential or concomitant add-on of dapagliflozin and saxagliptin to metformin. In the concomitant add-on trial, patients with type 2 diabetes on stable metformin received dapagliflozin 10 mg/d plus saxagliptin 5 mg/d. In sequential add-on trials, patients on metformin plus either saxagliptin 5 mg/d or dapagliflozin 10 mg/d received dapagliflozin 10 mg/d or saxagliptin 5 mg/d, respectively, as add-on therapy. After 24 weeks, incidences of adverse events and serious adverse events were similar between triple and dual therapy and between concomitant and sequential add-on regimens. Urinary tract infections were more common with sequential than with concomitant add-on therapy; genital infections were reported only with sequential add-on of dapagliflozin to saxagliptin plus metformin. Hypoglycaemia incidence was <2.0% across all analysis groups. In conclusion, the safety and tolerability of triple therapy with dapagliflozin, saxagliptin and metformin, as either concomitant or sequential add-on, were similar to dual therapy with either agent added to metformin.

Indexed as

AdamantaneBenzhydryl CompoundsDiabetes Mellitus, Type 2DipeptidesDipeptidyl-Peptidase IV InhibitorsDouble-Blind MethodDrug Therapy, CombinationFemaleGlucosidesGlycated HemoglobinHumansHypoglycemiaHypoglycemic AgentsMaleMetforminMiddle AgedAdamantaneBenzhydryl CompoundsdapagliflozinDipeptidesDipeptidyl-Peptidase IV InhibitorsGlucosidesGlycated HemoglobinHypoglycemic AgentsMetforminsaxagliptinSodium-Glucose Transporter 2 InhibitorsdapagliflozinDPP-4 inhibitormetforminSGLT-2 inhibitortype 2 diabetes

Identifiers

PMID29446523
PMCPMC5969059
OpenAlexW2790320081

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.