Evidence map›Paper›PMID 31912513›Full record

Trial reportBritish journal of clinical pharmacology2020

Safety, tolerability, pharmacokinetics and pharmacodynamics of parenterally administered dutogliptin: A prospective dose-escalating trial.

Nina Buchtele, Michael Schwameis, Christian Schoergenhofer, Ulla Derhaschnig, Christa Firbas, Rudolf Karch, Darrell Nix, Roman Schenk, Bernd Jilma

Open access · greenAbstract readClinical Trial
In one paragraph

Trial report in British journal of clinical pharmacology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
0.9field-weighted citation impact, top 26% 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

6 citing papers in PubMed, 12 citations in OpenAlex.

  1. Trial
  2. Article
  3. Review
  4. Review
  5. Review
  6. 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

9 authors at 3 institutions in 2 countries.

Nina BuchteleDepartment of Clinical Pharmacology, Medical University of Vienna, Austria.ORCID 0000-0002-1270-6452
Michael SchwameisDepartment of Emergency Medicine, Medical University of Vienna, Austria.
Christian SchoergenhoferDepartment of Clinical Pharmacology, Medical University of Vienna, Austria.ORCID 0000-0002-2286-1077
Ulla DerhaschnigDepartment of Clinical Pharmacology, Medical University of Vienna, Austria.
Christa FirbasDepartment of Clinical Pharmacology, Medical University of Vienna, Austria.
Rudolf KarchSection of Biosimulation and Bioinformatics, Center for Medical Statistics, Informatics and Intelligent Systems (CeMSIIS), Medical University of Vienna, Austria.
Darrell NixRECARDIO Inc., San Francisco, CA, USA.
Roman SchenkRECARDIO Inc., San Francisco, CA, USA.
Bernd JilmaDepartment of Clinical Pharmacology, Medical University of Vienna, Austria.ORCID 0000-0001-5652-7977
Medical University of Vienna · ATCalifornia Department of Parks and Recreation · USStatistics Austria · AT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsAnimal studies suggest that inhibition of dipeptidyl peptidase 4 (DPP-IV) may improve heart function and survival after myocardial infarction by increasing cardiac myocytes' regenerative capacity. Parenterally administered dutogliptin may provide continuous strong DPP-IV inhibition to translate these results into humans. This trial investigated the safety and tolerability, as well as pharmacokinetics and pharmacodynamics, of parenterally administered dutogliptin after single and repeated doses.

methodsIn an open-label trial, volunteers received dutogliptin at increasing doses of 30-120 mg subcutaneously or 30 mg intravenously in the single-dose cohorts. Subjects in the multiple-dose cohort received 60, 90 or 120 mg dutogliptin subcutaneously once daily on 7 consecutive days.

resultsForty healthy males were included in the trial. No related serious adverse events occurred. Mild local injection site reactions with no requirement for intervention comprised 147 of 153 (96%) related adverse events. Subcutaneous bioavailability was approximately 100%. Multiple injections at daily intervals did not lead to the accumulation of the study drug. The accumulation ratios based on AUC

conclusionParenteral injection of dutogliptin was safe and subcutaneous bioavailability is excellent. DPP-IV inhibition increased dose dependently to >86% over 24 hours after multiple doses of 120 mg dutogliptin.

Indexed as

Boronic AcidsDipeptidyl-Peptidase IV InhibitorsAdultDose-Response Relationship, DrugDouble-Blind MethodHumansMaleProspective StudiesBoronic AcidsDipeptidyl-Peptidase IV Inhibitorsdutogliptindutogliptinhealthyparenteralpharmacokinetics/pharmacodynamicssafety

Identifiers

PMID31912513
PMCPMC7163368
OpenAlexW2998833015

What OpenQuestion holds

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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 OpenQuestion graph.