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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01508806




Registration number
NCT01508806
Ethics application status
Date submitted
9/01/2012
Date registered
12/01/2012
Date last updated
24/01/2017

Titles & IDs
Public title
Safety and Tolerability of Liraglutide in Subjects With Impaired Kidney Function and in Subjects With Normal Kidney Function
Scientific title
A Single-centre, Open-label, Trial Investigating the Pharmacokinetics and the Tolerability of Liraglutide in Subjects With Normal Renal Function and in Subjects With Impaired Renal Function
Secondary ID [1] 0 0
NN2211-1329
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes 0 0
Diabetes Mellitus, Type 2 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - liraglutide

Experimental: Normal renal function -

Experimental: Mild renal impairment -

Experimental: Moderate renal impairment -

Experimental: Severe renal impairment -

Experimental: End-stage renal disease -


Treatment: Drugs: liraglutide
Single dose of 0.75 mg, administered as a subcutaneous injection
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Area under the Curve (AUC)
Timepoint [1] 0 0
Secondary outcome [1] 0 0
AUC (0-t)
Timepoint [1] 0 0
Secondary outcome [2] 0 0
Cmax, maximum concentration
Timepoint [2] 0 0
Secondary outcome [3] 0 0
tmax, time to reach Cmax
Timepoint [3] 0 0
Secondary outcome [4] 0 0
t½, terminal half-life
Timepoint [4] 0 0
Secondary outcome [5] 0 0
CLR (renal clearance)
Timepoint [5] 0 0
Secondary outcome [6] 0 0
Adverse events
Timepoint [6] 0 0

Eligibility
Key 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
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/08/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/03/2006
Sample size
Target
Accrual to date
Final
30
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Novo Nordisk Investigational Site - Christchurch
Recruitment postcode(s) [1] 0 0
2856 - Christchurch

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Novo Nordisk A/S
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Global Clinical Registry (GCR, 1452)
Address 0 0
Novo Nordisk A/S
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

TypeCitations or Other Details
Journal Jacobsen LV, Hindsberger C, Robson R, Zdravkovic M... [More Details]

Results not provided in https://clinicaltrials.gov/study/NCT01508806