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Trial · Interventional

CompletedPhase 1Registry data

Pharmacokinetics, Safety and Tolerability of Oral Semaglutide in Subjects With Various Degrees of Impaired Renal Function

NCTNCT02014259 (opens ClinicalTrials.gov in a new tab)Other idNN9924-4079Other id2013-000682-36Other idU1111-1139-4281
Open at ClinicalTrials.govAsk about this trial

Overview

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

Czechia, Hungary

Start
11 Dec 2013
Primary completion
24 Oct 2014
Completion
24 Oct 2014
First posted
18 Dec 2013 (estimated)
Last update posted
19 Apr 2018
Conditions
Diabetes · Diabetes Mellitus, Type 2 · Healthy

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201320142015
  1. Ph 1

    Pharmacokinetics, Safety and Tolerability of Oral Semaglutide in Subjects With Various Degrees of Impaired Renal Function

    NCT02014259

    11 Dec 2013 to 24 Oct 2014

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 the trial is to investigate the pharmacokinetics (the exposure of the trial drug in the body), safety and tolerability of oral semaglutide in subjects with various degrees of impaired renal function compared to subjects with normal renal function.

Interventions

  • semaglutideDrug

Arms2

  • Experimental

    Subjects with renal impairment

  • Active comparator

    Subjects with normal renal function

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Area under the semaglutide plasma concentration time curve

    Time frame · From time 0 to 24 hours after the 10th dosing

Secondary outcomes(3)

  1. Maximum observed semaglutide plasma concentration

    Time frame · 0 to 24 hours after the 10th dosing

  2. Area under the SNAC (Sodium N-[8-(2-hydroxybenzoyl) amino] caprylate /salcaprozate sodium) plasma concentration time curve

    Time frame · From time 0 to 24 hours after the 10th dosing

  3. Maximum observed SNAC plasma concentration

    Time frame · 0 to 24 hours after the 10th dosing

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 · 2018

6 results

Pharmacokinetics, Safety and Tolerability of Oral Semaglutide in Subjects with Renal Impairment.

Granhall et al. 2018Clinical pharmacokineticscited by 88

PMID 29623579PMC6267549DOI 10.1007/s40262-018-0649-2PUB-29623579

Free to read · publisher termsCC BY-NC6 results
Read at sourceSee results (6)

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 85 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Male or female aged 18-85 years (both inclusive) at the time of signing inform consent * Subject with normal renal function or renal impairment (mild, moderate, severe or end-stage renal disease requiring dialysis) * For subject with normal renal function: good general health (as judged by the investigator) * Body mass index (BMI) 18.5-40.0 kg/m\^2 (both inclusive) 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 * History of Crohn's disease, ulcerative colitis, or other inflammatory bowel disease * Uncontrolled hypertension (defined as systolic blood pressure above or equal to 180 mmHg and/or diastolic blood pressure above or equal to 100 mmHg) * Any blood draw or donation of blood or plasma in excess of 400 mL within the 3 months preceding the screening visit (Visit 2) * History of significant drug abuse, or a positive drug test at the screening visit (Visit 2)

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