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Effect of Renal Impairment on the Pharmacokinetics of NN9535

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00833716
First Posted: February 2, 2009
Last Update Posted: April 4, 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
January 29, 2009
February 2, 2009
April 4, 2017
February 2, 2009
July 26, 2010   (Final data collection date for primary outcome measure)
AUC of NN9535 [ Time Frame: at 21 days ]
AUC of NN9535 [ Time Frame: 21 days ]
Complete list of historical versions of study NCT00833716 on ClinicalTrials.gov Archive Site
Laboratory safety, adverse events [ Time Frame: at 21 days ]
Laboratory safety, adverse events [ Time Frame: 21 days ]
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
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Diabetes
  • Diabetes Mellitus, Type 2
  • Renal Impairment
Drug: semaglutide
10 mg/mL of semaglutide solution for s.c. injection, single dose
Other Name: NN9535
Experimental: A
Intervention: Drug: semaglutide

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
62
July 26, 2010
July 26, 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
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00833716
NN9535-3616
No
Not Provided
Not Provided
Novo Nordisk A/S
Novo Nordisk A/S
Not Provided
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
Novo Nordisk A/S
March 2017

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