Back to resultsSafety and Tolerability of Liraglutide in Subjects With Impaired Kidney Function and in Subjects With Normal Kidney Function
Primary Purpose
Diabetes, Diabetes Mellitus, Type 2
Status
Completed
Phase
Phase 1
Locations
Australia
Study Type
Interventional
Intervention
liraglutide
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes
Eligibility Criteria
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
Sites / Locations
- Novo Nordisk Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
Normal renal function
Mild renal impairment
Moderate renal impairment
Severe renal impairment
End-stage renal disease
Arm Description
Outcomes
Primary Outcome Measures
Area under the Curve (AUC)
Secondary Outcome Measures
AUC (0-t)
Cmax, maximum concentration
tmax, time to reach Cmax
t½, terminal half-life
CLR (renal clearance)
Adverse events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01508806
Brief Title
Safety and Tolerability of Liraglutide in Subjects With Impaired Kidney Function and in Subjects With Normal Kidney Function
Official 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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
August 2005 (undefined)
Primary Completion Date
March 2006 (Actual)
Study Completion Date
March 2006 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novo Nordisk A/S
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Diabetes Mellitus, Type 2
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Normal renal function
Arm Type
Experimental
Arm Title
Mild renal impairment
Arm Type
Experimental
Arm Title
Moderate renal impairment
Arm Type
Experimental
Arm Title
Severe renal impairment
Arm Type
Experimental
Arm Title
End-stage renal disease
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
liraglutide
Intervention Description
Single dose of 0.75 mg, administered as a subcutaneous injection
Primary Outcome Measure Information:
Title
Area under the Curve (AUC)
Secondary Outcome Measure Information:
Title
AUC (0-t)
Title
Cmax, maximum concentration
Title
tmax, time to reach Cmax
Title
t½, terminal half-life
Title
CLR (renal clearance)
Title
Adverse events
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Registry (GCR, 1452)
Organizational Affiliation
Novo Nordisk A/S
Official's Role
Study Director
Facility Information:
Facility Name
Novo Nordisk Investigational Site
City
Christchurch
ZIP/Postal Code
2856
Country
Australia
12. IPD Sharing Statement
Citations:
PubMed Identifier
20002084
Citation
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.
Results Reference
result
Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk
Learn more about this trial
Safety and Tolerability of Liraglutide in Subjects With Impaired Kidney Function and in Subjects With Normal Kidney Function
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