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Trial · Interventional

CompletedPhase 1Registry data

Investigating the Influence of Oral Semaglutide on Pharmacokinetics of Metformin and Digoxin in Healthy Subjects

NCTNCT02249910 (opens ClinicalTrials.gov in a new tab)Other idNN9924-4145Other id2013-004820-12Other idU1111-1150-0801

Overview

Status
Completed
Phase
Phase 1
Enrollment
32 participants (actual)
Sponsor
Novo Nordisk A/S · Industry
Design
Not randomized · Open label (no masking)
Countries
1 country

Germany

Start
18 Sept 2014
Primary completion
6 Mar 2015
Completion
6 Mar 2015
First posted
26 Sept 2014 (estimated)
Last update posted
17 Feb 2020
Conditions
Diabetes · Healthy

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201420152016
  1. Ph 1

    Investigating the Influence of Oral Semaglutide on Pharmacokinetics of Metformin and Digoxin in Healthy Subjects

    NCT02249910

    18 Sept 2014 to 6 Mar 2015

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

This trial is conducted in Europe. The aim of this trial is to investigate the influence of oral semaglutide on pharmacokinetics (the exposure of the trial drug in the body) of metformin and digoxin in healthy subjects.

Interventions

  • semaglutideDrug
  • metforminDrug
  • digoxinDrug
  • placeboDrug

Arms1

  • Experimental

    Semaglutide

Primary outcomes2

Outcomes the sponsor listed as primary.

  1. Area under the metformin plasma concentration-time curve

    Time frame · During a dosing interval (0 to12 hours) at steady state

  2. Area under the digoxin plasma concentration-time curve

    Time frame · From time 0 to infinity after single dose

Secondary outcomes(5)
  1. Maximum observed metformin plasma concentration

    Time frame · During a dosing interval (0 to 12 hours) at steady state

  2. Maximum observed digoxin plasma concentration

    Time frame · 0 to 120 hours after single dose

  3. Maximum observed semaglutide plasma concentration

    Time frame · During a dosing interval (0 to 24 hours) at steady state

  4. Area under the SNAC plasma concentration-time curve

    Time frame · During a dosing interval (0 to 24 hours) at steady state

  5. Number of hypoglycaemic episodes

    Time frame · From the first dosing (Day 1) and until completion of the post treatment follow up visit (Day 118-122)

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Clinical trial · 2019

6 results

Effect of Oral Semaglutide on the Pharmacokinetics of Lisinopril, Warfarin, Digoxin, and Metformin in Healthy Subjects.

Bækdal et al. 2019Clinical pharmacokineticscited by 52

PMID 30945118PMC6719321DOI 10.1007/s40262-019-00756-2PUB-30945118

Free to read · publisher termsCC BY-NC6 results

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 75 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Male or female, age 18-75 years (both inclusive) at the time of signing inform consent * Body mass index (BMI) 20.0-29.9 kg/m\^2 (both inclusive) * A good general health based on medical history, physical examination, and results of vital signs, electrocardiogram and laboratory safety tests performed during the screening visit, as judged by the investigator Exclusion Criteria: * Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using adequate contraceptive methods. Female of child bearing potential must use effective methods of birth control for the duration of the trial and for 5 weeks following last dose. Only highly effective methods of birth control are accepted (i.e., one that results in a less than 1% per year failure rate when used consistently and correctly, such as implants, injectables, combined oral contraceptives, and some intrauterine devices) * History of Crohn's disease, ulcerative colitis, or other inflammatory bowel disease * Hypertension (defined as sitting systolic blood pressure above 140 mmHg and/or diastolic blood pressure above 90 mmHg). If white-coat hypertension is suspected at the screening visit a repeated measurement is allowed * Any blood draw in excess of 25 mL in the past month, or donation of blood or plasma in excess of 400 mL within the 3 months preceding screening

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