Back to resultsEffect of Renal Impairment on the Pharmacokinetics of NN9535
Primary Purpose
Diabetes, Diabetes Mellitus, Type 2, Renal Impairment
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
semaglutide
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes
Eligibility Criteria
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
Sites / Locations
- Novo Nordisk Investigational Site
- Novo Nordisk Investigational Site
- Novo Nordisk Investigational Site
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
A
Arm Description
Outcomes
Primary Outcome Measures
AUC of NN9535
Secondary Outcome Measures
Laboratory safety, adverse events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00833716
Brief Title
Effect of Renal Impairment on the Pharmacokinetics of NN9535
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
February 2, 2009 (Actual)
Primary Completion Date
July 26, 2010 (Actual)
Study Completion Date
July 26, 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novo Nordisk A/S
4. Oversight
Data Monitoring Committee
No
5. Study Description
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 disease) affect the pharmacokinetics of NN9535.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Diabetes Mellitus, Type 2, Renal Impairment
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
62 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
semaglutide
Other Intervention Name(s)
NN9535
Intervention Description
10 mg/mL of semaglutide solution for s.c. injection, single dose
Primary Outcome Measure Information:
Title
AUC of NN9535
Time Frame
at 21 days
Secondary Outcome Measure Information:
Title
Laboratory safety, adverse events
Time Frame
at 21 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Registry (GCR, 1452)
Organizational Affiliation
Novo Nordisk A/S
Official's Role
Study Director
Facility Information:
Facility Name
Novo Nordisk Investigational Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33014
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37920
Country
United States
12. IPD Sharing Statement
Citations:
Citation
Marbury T, Flint A, Segel S, Lindegaard M, Lasseter K. Pharmacokinetics and tolerability of semaglutide, a once-weekly human GLP-1 analog, in subjects with and without renal impairment. Diabetes 2014; 63 (Suppl 1): A260 (abstract 1010-P)
Results Reference
result
PubMed Identifier
28349386
Citation
Marbury TC, Flint A, Jacobsen JB, Derving Karsbol J, Lasseter K. Pharmacokinetics and Tolerability of a Single Dose of Semaglutide, a Human Glucagon-Like Peptide-1 Analog, in Subjects With and Without Renal Impairment. Clin Pharmacokinet. 2017 Nov;56(11):1381-1390. doi: 10.1007/s40262-017-0528-2.
Results Reference
result
Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk
Learn more about this trial
Effect of Renal Impairment on the Pharmacokinetics of NN9535
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