Effect of Renal Impairment on the Pharmacokinetics of NN9535

Completed · Phase 1

Conditions studied: Diabetes, Diabetes Mellitus, Type 2, Renal Impairment

In brief

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.

Key facts

Study ID

NCT00833716

Run by

Novo Nordisk A/S

People needed

62

Starts

2009-02-02

Expected to finish

2010-07-26

Last updated by the study team

2017-04-04

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Novo Nordisk Investigational Site — Miami, Florida, United States
• Novo Nordisk Investigational Site — Orlando, Florida, United States
• Novo Nordisk Investigational Site — Knoxville, Tennessee, United States

Full record on ClinicalTrials.gov

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