Effect of Renal Impairment on the Pharmacokinetics of NN9535

Diabetes Mellitus, Type 2 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00833716
• Other study ID #: NN9535-3616
• Status: Completed
• Phase: Phase 1
• First received: January 29, 2009
• Last updated: March 31, 2017
• Start date: February 2, 2009
• Est. completion date: July 26, 2010

Study information

• Verified date: March 2017
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: July 26, 2010
• Est. primary completion date: July 26, 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Renal Impairment
• Renal Insufficiency

Intervention

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

Locations

Country	Name	City	State
United States	Novo Nordisk Investigational Site	Knoxville	Tennessee
United States	Novo Nordisk Investigational Site	Miami	Florida
United States	Novo Nordisk Investigational Site	Orlando	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

United States, 

References & Publications (2)

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 Karsbøl 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 Mar 27. doi — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUC of NN9535		at 21 days
Secondary	Laboratory safety, adverse events		at 21 days

External Links

•   Clinical Trials at Novo Nordisk