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Trial · Interventional

CompletedPhase 1Registry data

Safety and Tolerability of Liraglutide in Subjects With Impaired Kidney Function and in Subjects With Normal Kidney Function

NCTNCT01508806 (opens ClinicalTrials.gov in a new tab)Other idNN2211-1329
Open at ClinicalTrials.govAsk about this trial

Overview

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

Australia

Start
Aug 2005
Primary completion
Mar 2006
Completion
Mar 2006
First posted
12 Jan 2012 (estimated)
Last update posted
24 Jan 2017 (estimated)
Conditions
Diabetes · Diabetes Mellitus, Type 2

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
200520062007
  1. Ph 1

    Safety and Tolerability of Liraglutide in Subjects With Impaired Kidney Function and in Subjects With Normal Kidney Function

    NCT01508806

    Aug 2005 to Mar 2006

Registry summary

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

This trial is conducted in Oceania. The aim of this trial is to assess whether dose adjustment is required for patients with renal impairment by investigating the pharmacokinetics of liraglutide in subjects with various degrees of renal impairment.

Interventions

  • liraglutideDrug

Arms5

  • Experimental

    Normal renal function

  • Experimental

    Mild renal impairment

  • Experimental

    Moderate renal impairment

  • Experimental

    Severe renal impairment

  • Experimental

    End-stage renal disease

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Area under the Curve (AUC)

Secondary outcomes(6)

  1. AUC (0-t)

  2. Cmax, maximum concentration

  3. tmax, time to reach Cmax

  4. t½, terminal half-life

  5. CLR (renal clearance)

  6. Adverse events

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 · 2009

6 results

Effect of renal impairment on the pharmacokinetics of the GLP-1 analogue liraglutide.

Jacobsen et al. 2009British journal of clinical pharmacologycited by 144

PMID 20002084PMC2810801DOI 10.1111/j.1365-2125.2009.03536.xPUB-20002084

Rights unknown6 results
Source linkSee results (6)

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: * Subjects meeting the pre-defined GFR (glomerular filtration rate) criteria (estimated by the Cockcroft and Gault formula) for any of the renal function groups * Body Mass Index (BMI) maximum 40 kg/m\^2 Exclusion Criteria: * Known or suspected allergy to trial product(s) or related products * Renal transplanted patients * Haemodialysis patients * Cardiac problems * Uncontrolled treated/untreated hypertension * History of alcoholism or drug abuse during the last 12 months * Smoking of more than 10 cigarettes per day, or the equivalent for other tobacco products * Habitual excessive consumption of methylxanthine-containing beverages and foods (coffee, tea, soft drinks such as cola, chocolate) as judged by the investigator * Excessive consumption of food deviating from a normal diet as judged by the Investigator

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