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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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
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 website
https://clinicaltrials.gov/ct2/show/NCT01508806
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