Effect of Renal Impairment on the Pharmacokinetics of NN9535

• ClinicalTrials.gov Identifier: NCT00833716
• Recruitment Status: Completed
• First Posted: February 2, 2009
• Last Update Posted: April 4, 2017
• Sponsor: Novo Nordisk A/S
• Information provided by (Responsible Party): Novo Nordisk A/S

Tracking Information

• First Submitted Date: January 29, 2009
• First Posted Date: February 2, 2009
• Last Update Posted Date: April 4, 2017
• Actual Study Start Date: February 2, 2009
• Actual Primary Completion Date: July 26, 2010 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: February 5, 2009): AUC of NN9535 [ Time Frame: at 21 days ]
• Original Primary Outcome Measures (submitted: January 30, 2009): AUC of NN9535 [ Time Frame: 21 days ]
• Current Secondary Outcome Measures (submitted: February 5, 2009): Laboratory safety, adverse events [ Time Frame: at 21 days ]
• Original Secondary Outcome Measures (submitted: January 30, 2009): Laboratory safety, adverse events [ Time Frame: 21 days ]
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Diabetes
• Diabetes Mellitus, Type 2
• Renal Impairment

Intervention

Drug: semaglutide

10 mg/mL of semaglutide solution for s.c. injection, single dose

Other Name: NN9535

Study Arms

Experimental: A

Intervention: Drug: semaglutide

Publications *

• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: August 11, 2010): 62
• Original Estimated Enrollment (submitted: January 30, 2009): 54
• Actual Study Completion Date: July 26, 2010
• Actual Primary Completion Date: July 26, 2010 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00833716
• Other Study ID Numbers: NN9535-3616
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Novo Nordisk A/S
• Original Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
• Current Study Sponsor: Novo Nordisk A/S
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Global Clinical Registry (GCR, 1452); Novo Nordisk A/S

• PRS Account: Novo Nordisk A/S
• Verification Date: March 2017