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Trial · Interventional

CompletedPhase 1Registry data

Effect of Renal Impairment on the Pharmacokinetics of NN9535

NCTNCT00833716 (opens ClinicalTrials.gov in a new tab)Other idNN9535-3616
Open at ClinicalTrials.govAsk about this trial

Overview

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

United States

Start
2 Feb 2009
Primary completion
26 Jul 2010
Completion
26 Jul 2010
First posted
2 Feb 2009 (estimated)
Last update posted
4 Apr 2017
Conditions
Diabetes · Diabetes Mellitus, Type 2 · Renal Impairment

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
200920102011
  1. Ph 1

    Effect of Renal Impairment on the Pharmacokinetics of NN9535

    NCT00833716

    2 Feb 2009 to 26 Jul 2010

Registry summary

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

This trial is conducted in the United States of America (USA). The aim of this clinical trial is to investigate how different degrees of renal impairment (mild, moderate, severe and end-stage renal disease) affect the pharmacokinetics of NN9535.

Interventions

  • semaglutideDrug

Arms1

  • Experimental

    A

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. AUC of NN9535

    Time frame · at 21 days

Secondary outcomes(1)

  1. Laboratory safety, adverse events

    Time frame · at 21 days

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 · 2017

7 results

Pharmacokinetics and Tolerability of a Single Dose of Semaglutide, a Human Glucagon-Like Peptide-1 Analog, in Subjects With and Without Renal Impairment.

Marbury et al. 2017Clinical pharmacokineticscited by 102

PMID 28349386PMC5648736DOI 10.1007/s40262-017-0528-2PUB-28349386

Free to read · publisher termsCC BY-NC7 results
Read at sourceSee results (7)

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

  • ResultMarbury T, Flint A, Segel S, Lindegaard M, Lasseter K. Pharmacokinetics and tolerability of semaglutide, a once-weekly human GLP-1 analog, in subjects with and without renal impairment. Diabetes 2014; 63 (Suppl 1): A260 (abstract 1010-P)

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 75 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Informed consent obtained before any trial-related activities. (Trial-related activities are any procedure that would not have been performed during normal management of the subject) * Subjects meeting the pre-defined GFR (glomerular filtration rate) criteria (estimated by the Cockcroft \& Gault formula) for any of the renal function groups * Body Mass Index (BMI) equal to or less than 40kg/m2 Exclusion Criteria: * Known or suspected allergy to trial product(s) or related products * Renal transplanted patients * Certain cardiac problems (heart failure, unstable angina, MI (myocardial infarction) within the last 3 months) * Known current hepatic dysfunction or severe hepatic disease during the last 12 months * Female of childbearing potential/breast feeding * History of alcoholism or drug abuse * Blood donation during the last 8 weeks prior to the study * Past or current history of pancreatitis

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