Effect of Renal Impairment on the Pharmacokinetics of NN9535
NCT ID: NCT00833716
Last Updated: 2017-04-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
62 participants
INTERVENTIONAL
2009-02-02
2010-07-26
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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A
semaglutide
10 mg/mL of semaglutide solution for s.c. injection, single dose
Interventions
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semaglutide
10 mg/mL of semaglutide solution for s.c. injection, single dose
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
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Novo Nordisk A/S
INDUSTRY
Responsible Party
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Principal Investigators
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Global Clinical Registry (GCR, 1452)
Role: STUDY_DIRECTOR
Novo Nordisk A/S
Locations
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Novo Nordisk Investigational Site
Miami, Florida, United States
Novo Nordisk Investigational Site
Orlando, Florida, United States
Novo Nordisk Investigational Site
Knoxville, Tennessee, United States
Countries
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References
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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)
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.
Related Links
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Clinical Trials at Novo Nordisk
Other Identifiers
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NN9535-3616
Identifier Type: -
Identifier Source: org_study_id
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