Status:
COMPLETED
Effect of Renal Impairment on the Pharmacokinetics of NN9535
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Diabetes
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief Summary
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 di...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 2 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 26 2010
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT00833716
Start Date
February 2 2009
End Date
July 26 2010
Last Update
April 4 2017
Active Locations (3)
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1
Novo Nordisk Investigational Site
Miami, Florida, United States, 33014
2
Novo Nordisk Investigational Site
Orlando, Florida, United States, 32806
3
Novo Nordisk Investigational Site
Knoxville, Tennessee, United States, 37920