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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:
ClinicalTrials.gov Identifier:
NCT01508806
First Posted: January 12, 2012
Last Update Posted: January 24, 2017
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 evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novo Nordisk A/S
  Purpose
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.

Condition Intervention Phase
Diabetes Diabetes Mellitus, Type 2 Drug: liraglutide Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

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

Enrollment: 30
Study Start Date: August 2005
Study Completion Date: March 2006
Primary Completion Date: March 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Normal renal function Drug: liraglutide
Single dose of 0.75 mg, administered as a subcutaneous injection
Experimental: Mild renal impairment Drug: liraglutide
Single dose of 0.75 mg, administered as a subcutaneous injection
Experimental: Moderate renal impairment Drug: liraglutide
Single dose of 0.75 mg, administered as a subcutaneous injection
Experimental: Severe renal impairment Drug: liraglutide
Single dose of 0.75 mg, administered as a subcutaneous injection
Experimental: End-stage renal disease Drug: liraglutide
Single dose of 0.75 mg, administered as a subcutaneous injection

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01508806


Locations
Australia
Novo Nordisk Investigational Site
Christchurch, Australia, 2856
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Publications:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01508806     History of Changes
Other Study ID Numbers: NN2211-1329
First Submitted: January 9, 2012
First Posted: January 12, 2012
Last Update Posted: January 24, 2017
Last Verified: January 2017

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Liraglutide
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists