NCT01508806

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1 diabetes

Timeline
Completed

Started Aug 2005

Typical duration for phase_1 diabetes

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2005

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2006

Completed
5.9 years until next milestone

First Submitted

Initial submission to the registry

January 9, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 12, 2012

Completed
Last Updated

January 24, 2017

Status Verified

January 1, 2017

Enrollment Period

7 months

First QC Date

January 9, 2012

Last Update Submit

January 23, 2017

Conditions

DiabetesDiabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

  • Area under the Curve (AUC)

Secondary Outcomes (6)

  • AUC (0-t)

  • Cmax, maximum concentration

  • tmax, time to reach Cmax

  • t½, terminal half-life

  • CLR (renal clearance)

  • +1 more secondary outcomes

Study Arms (5)

Normal renal function

EXPERIMENTAL
Drug: liraglutide

Mild renal impairment

EXPERIMENTAL
Drug: liraglutide

Moderate renal impairment

EXPERIMENTAL
Drug: liraglutide

Severe renal impairment

EXPERIMENTAL
Drug: liraglutide

End-stage renal disease

EXPERIMENTAL
Drug: liraglutide

Interventions

liraglutideDRUG

Single dose of 0.75 mg, administered as a subcutaneous injection

End-stage renal diseaseMild renal impairmentModerate renal impairmentNormal renal functionSevere renal impairment

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novo Nordisk Investigational Site

Christchurch, 2856, Australia

Location

Related Publications (1)

  • Jacobsen LV, Hindsberger C, Robson R, Zdravkovic M. Effect of renal impairment on the pharmacokinetics of the GLP-1 analogue liraglutide. Br J Clin Pharmacol. 2009 Dec;68(6):898-905. doi: 10.1111/j.1365-2125.2009.03536.x.

    PMID: 20002084RESULT

Related Links

MeSH Terms

Conditions

Diabetes MellitusDiabetes Mellitus, Type 2

Interventions

Liraglutide

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide 1Glucagon-Like PeptidesProglucagonGastrointestinal HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

  • Global Clinical Registry (GCR, 1452)

    Novo Nordisk A/S

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 9, 2012

First Posted

January 12, 2012

Study Start

August 1, 2005

Primary Completion

March 1, 2006

Study Completion

March 1, 2006

Last Updated

January 24, 2017

Record last verified: 2017-01

Locations

AU(1)