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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01508806

Enrollment

Registered

2012-01-12

Start date

2005-08-31

Completion date

2006-03-31

Last updated

2017-01-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes, Diabetes Mellitus, Type 2

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.

Interventions

DRUGliraglutide

Single dose of 0.75 mg, administered as a subcutaneous injection

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Area under the Curve (AUC)	—

Secondary

Measure	Time frame
Cmax, maximum concentration	—
tmax, time to reach Cmax	—
AUC (0-t)	—
CLR (renal clearance)	—
Adverse events	—
t½, terminal half-life	—

Countries

Australia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026