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

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT01508806
First received: January 9, 2012
Last updated: NA
Last verified: January 2012
History: No changes posted

January 9, 2012
January 9, 2012
August 2005
March 2006   (final data collection date for primary outcome measure)
Area under the Curve (AUC) [ Designated as safety issue: No ]
Same as current
No Changes Posted
  • AUC (0-t) [ Designated as safety issue: No ]
  • Cmax, maximum concentration [ Designated as safety issue: No ]
  • tmax, time to reach Cmax [ Designated as safety issue: No ]
  • t½, terminal half-life [ Designated as safety issue: No ]
  • CLR (renal clearance) [ Designated as safety issue: No ]
  • Adverse events [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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

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.
Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Diabetes
  • Diabetes Mellitus, Type 2
Drug: liraglutide
Single dose of 0.75 mg, administered as a subcutaneous injection
  • Experimental: Normal renal function
    Intervention: Drug: liraglutide
  • Experimental: Mild renal impairment
    Intervention: Drug: liraglutide
  • Experimental: Moderate renal impairment
    Intervention: Drug: liraglutide
  • Experimental: Severe renal impairment
    Intervention: Drug: liraglutide
  • Experimental: End-stage renal disease
    Intervention: Drug: liraglutide
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
March 2006
March 2006   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
New Zealand
 
NCT01508806
NN2211-1329
No
Public Access to Clinical Trials, Novo Nordisk A/S
Novo Nordisk
Not Provided
Study Director: Milan Zdravkovic, MD, PhD Novo Nordisk
Novo Nordisk
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP