Effect of Renal Impairment on the Pharmacokinetics of NN9535

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00833716
First received: January 29, 2009
Last updated: July 5, 2012
Last verified: March 2012

January 29, 2009
July 5, 2012
February 2009
July 2010   (final data collection date for primary outcome measure)
AUC of NN9535 [ Time Frame: at 21 days ] [ Designated as safety issue: No ]
AUC of NN9535 [ Time Frame: 21 days ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00833716 on ClinicalTrials.gov Archive Site
Laboratory safety, adverse events [ Time Frame: at 21 days ] [ Designated as safety issue: Yes ]
Laboratory safety, adverse events [ Time Frame: 21 days ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Effect of Renal Impairment on the Pharmacokinetics of NN9535
An Open-label Trial Investigating the Pharmacokinetics and the Tolerability of NN9535 in Subjects With Normal Renal Function and Various Degrees of Impaired Renal Function

This trial is conducted in the United States of America (USA). The aim of this clinical trial is to investigate how different degrees of renal impairment (mild, moderate, severe and end-stage renal disease) affect the pharmacokinetics of NN9535.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Diabetes
  • Diabetes Mellitus, Type 2
  • Renal Impairment
Drug: NN9535
10 mg/mL of NN9535 solution for s.c. injection, single dose
Experimental: A
Intervention: Drug: NN9535
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
62
July 2010
July 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Informed consent obtained before any trial-related activities. (Trial-related activities are any procedure that would not have been performed during normal management of the subject)
  • Subjects meeting the pre-defined GFR (glomerular filtration rate) criteria (estimated by the Cockcroft & Gault formula) for any of the renal function groups
  • Body Mass Index (BMI) equal to or less than 40kg/m2

Exclusion Criteria:

  • Known or suspected allergy to trial product(s) or related products
  • Renal transplanted patients
  • Certain cardiac problems (heart failure, unstable angina, MI (myocardial infarction) within the last 3 months)
  • Known current hepatic dysfunction or severe hepatic disease during the last 12 months
  • Female of childbearing potential/breast feeding
  • History of alcoholism or drug abuse
  • Blood donation during the last 8 weeks prior to the study
  • Past or current history of pancreatitis
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00833716
NN9535-3616
No
Novo Nordisk A/S
Novo Nordisk A/S
Not Provided
Study Director: D J Chatterjee, PhD Novo Nordisk A/S
Novo Nordisk A/S
March 2012

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