Evidence mapPaperPMID 28474741Full record

Trial reportBritish journal of clinical pharmacology2017

Metformin and daclatasvir: absence of a pharmacokinetic-pharmacodynamic drug interaction in healthy volunteers.

Elise J Smolders, Angela Colbers, Clara T M M de Kanter, Kirsten Velthoven-Graafland, Leonie T Wolberink, Noor van Ewijk-Beneken Kolmer, Joost P H Drenth, Rob E Aarnoutse, Cees J Tack, David M Burger

Registry-linked trialOpen access · bronzeAbstract readRandomized Controlled Trial
In one paragraph

Trial report in British journal of clinical pharmacology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It reports registered trial NCT02565862. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
0.7field-weighted citation impact, top 30% 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.

NCT02565862 phase1completed

A Drug-drug Interaction Study Between the Novel Anti-hepatitis c Virus (HCV) Agent Daclatasvir and The Antidiabetic Agent Metformin in Healthy Volunteers

Ran2016Enrolled20Registered outcomes2Posted comparisons0ConditionsDiabetes Mellitus, Hepatitis C, Insulin ResistanceArmsDaclatasvir, Metformin
Open the trial in the graph
3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 9 citations in OpenAlex.

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

10 authors at 2 institutions in 1 country.

Elise J SmoldersDepartment of Pharmacy and Radboud Institute for Health Sciences (RIHS), Radboud university medical center, Nijmegen, the Netherlands.ORCID http://orcid.org/0000-0001-5694-9758
Angela ColbersDepartment of Pharmacy and Radboud Institute for Health Sciences (RIHS), Radboud university medical center, Nijmegen, the Netherlands.
Clara T M M de KanterDepartment of Pharmacy, University Medical Center Utrecht, Utrecht, the Netherlands.
Kirsten Velthoven-GraaflandDepartment of Pharmacy and Radboud Institute for Health Sciences (RIHS), Radboud university medical center, Nijmegen, the Netherlands.
Leonie T WolberinkDepartment of Pharmacy and Radboud Institute for Health Sciences (RIHS), Radboud university medical center, Nijmegen, the Netherlands.
Noor van Ewijk-Beneken KolmerDepartment of Pharmacy and Radboud Institute for Health Sciences (RIHS), Radboud university medical center, Nijmegen, the Netherlands.
Joost P H DrenthDepartment of Gastroenterology and Hepatology, Radboud university medical center, Nijmegen, the Netherlands.
Rob E AarnoutseDepartment of Pharmacy and Radboud Institute for Health Sciences (RIHS), Radboud university medical center, Nijmegen, the Netherlands.
Cees J TackDepartment of Internal Medicine, Radboud university medical center, Nijmegen, the Netherlands.
David M BurgerDepartment of Pharmacy and Radboud Institute for Health Sciences (RIHS), Radboud university medical center, Nijmegen, the Netherlands.
Radboud University Nijmegen · NLUtrecht University · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimThe aim of the present study was to evaluate the effect of the proposed organic cation transporter (OCT) inhibitor daclatasvir on the pharmacokinetics and pharmacodynamics of the OCT substrate metformin.

methodsThis was an open-label, two-period, randomized, crossover trial in 20 healthy subjects. Treatment A consisted of metformin and treatment B consisted of metformin + daclatasvir. Pharmacokinetic curves were recorded at steady-state. Geometric mean ratios (GMRs) with 90% confidence intervals (CIs) were calculated for metformin area under the concentration-time curve from 0 h to 12 h (AUC

resultsThe GMRs (90% CI) of metformin AUC

conclusionsBioequivalence analysis showed that daclatasvir does not influence the pharmacokinetics of metformin in healthy subjects. Pharmacodynamic parameters were also comparable between treatments.

Indexed as

Administration, OralAdultArea Under CurveBlood GlucoseCarbamatesCross-Over StudiesDiabetes Mellitus, Type 2Drug InteractionsFemaleGlucose Tolerance TestHealthy VolunteersHepatitis C, ChronicHumansHypoglycemic AgentsImidazolesInsulinBlood GlucoseCarbamatesdaclatasvirHypoglycemic AgentsImidazolesInsulinLactic AcidMetforminOctamer Transcription Factor-1Organic Cation Transporter 2POU2F1 protein, humanPyrrolidinesSLC22A2 protein, humanValinediabetesdrug interactionsdrug transportershepatitispharmacokinetic-pharmacodynamic

Identifiers

PMID28474741
PMCPMC5595943
OpenAlexW2611950068

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.