The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from

For full trial details, please see the original record at

Registration number
Ethics application status
Date submitted
Date registered
Date last updated

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
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

Study type
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

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

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
Both males and females
Can healthy volunteers participate?
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

- 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

Study design
Purpose of the study
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
Other design features
Phase 1
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
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
Novo Nordisk A/S

Ethics approval
Ethics application status

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
Trial related presentations / publications
Public notes

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

Summary results
Other publications