Evidence map›Paper›PMID 30617943›Full record

ArticleDiabetes therapy : research, treatment and education of diabetes and related disorders2019

Clinical Trials on Diabetic Nephropathy: A Cross-Sectional Analysis.

Sergio Modafferi, Markus Ries, Vittorio Calabrese, Claus P Schmitt, Peter Nawroth, Stefan Kopf, Verena Peters

Open access · goldAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Diabetes therapy : research, treatment and education of diabetes and related disorders, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.2field-weighted citation impact, top 47% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 5 citations in OpenAlex.

  1. Review
  2. Review
  3. Article
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

7 authors at 2 institutions in 3 countries.

Sergio ModafferiCenter for Pediatric and Adolescent Medicine, University of Heidelberg, Heidelberg, Germany.
Markus RiesCenter for Pediatric and Adolescent Medicine, University of Heidelberg, Heidelberg, Germany.
Vittorio CalabreseDepartment of Biomedical and Biotechnological Sciences, School of Medicine, University of Catania, Catania, Italy.
Claus P SchmittCenter for Pediatric and Adolescent Medicine, University of Heidelberg, Heidelberg, Germany.
Peter NawrothDepartment of Endocrinology, Diabetology and Clinical Chemistry, University Hospital Heidelberg, University Heidelberg, Heidelberg, Germany.
Stefan KopfDepartment of Endocrinology, Diabetology and Clinical Chemistry, University Hospital Heidelberg, University Heidelberg, Heidelberg, Germany.
Verena PetersCenter for Pediatric and Adolescent Medicine, University of Heidelberg, Heidelberg, Germany. Verena.Peters@med.uni-heidelberg.de.ORCID http://orcid.org/0000-0002-4649-0848
Heidelberg University · DEUniversity of Catania · IT

Funding

Deutsche Forschungsgemeinschaft SFB 11118
6 · The paper itself

Abstract

introductionTreatment options and decisions are often based on the results of clinical trials. We have evaluated the public availability of results from completed, registered phase III clinical trials on diabetic nephropathy and current treatment options.

methodsThis was a cross-sectional analysis in which STrengthening the Reporting of OBservational studies in Epidemiology criteria were applied for design and analysis. In June 2017, 34 completed phase III clinical trials on diabetic nephropathy in the ClinicalTrials. gov registry were identified and matched to publications in the ClinicalTrials.gov registry and to those in the PubMed and Google Scholar databases. If no publication was identified, the principal investigator was contacted. The ratio of published and non-published studies was calculated. Various parameters, including study design, drugs, and comparators provided, were analyzed.

resultsDrugs/supplements belonged to 26 different categories of medications, with the main ones being angiotensin-converting enzyme inhibitors, angiotensin-II receptors blockers, and dipeptidyl-peptidase-4-inhibitors. Among the trials completed before 2016 (n = 32), 22 (69%) were published, and ten (31%) remained unpublished. Thus, data on 11 different interventions and more than 1000 patients remained undisclosed. Mean time to publication was 26.5 months, which is longer than the time constrictions imposed by the U.S. Food and Drug Administration Amendments Act. Most trials only showed weak effects on micro- and macroalbuminuria, with an absolute risk reduction of 1.0 and 0.3%, respectively, and the number needed to treat varied between 91 and 333, without any relevant effect on end-stage-renal disease by intensive glucose-lowering treatment. Comparison of the results, however, was difficult since study design, interventions, and the renal outcome parameters vary greatly between the studies.

conclusionDespite the financial and human resources involved and the relevance for therapeutic guidelines and clinical decisions, about one-third of phase III clinical trials on diabetic nephropathy remain unpublished. Interventions used in published trials showed a low efficacy on renal outcome.

fundingDeutsche Forschungsgemeinschaft (DFG): SFB 1118.

Indexed as

ACE inhibitorsAngiotensin-II receptorsClinicalTrials.govDiabetes mellitusDiabetic nephropathyDipeptidyl-peptidase-4-inhibitorsPhase III clinical trials

Identifiers

PMID30617943
PMCPMC6349284
OpenAlexW2908900755

What Socratic holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

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.