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Effect of Renal Impairment on the Pharmacokinetics of NN9535

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00833716
First received: January 29, 2009
Last updated: March 31, 2017
Last verified: March 2017
  Purpose
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.

Condition Intervention Phase
Diabetes Diabetes Mellitus, Type 2 Renal Impairment Drug: semaglutide Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
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

Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • AUC of NN9535 [ Time Frame: at 21 days ]

Secondary Outcome Measures:
  • Laboratory safety, adverse events [ Time Frame: at 21 days ]

Enrollment: 62
Actual Study Start Date: February 2, 2009
Study Completion Date: July 26, 2010
Primary Completion Date: July 26, 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: semaglutide
10 mg/mL of semaglutide solution for s.c. injection, single dose
Other Name: NN9535

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00833716

Locations
United States, Florida
Novo Nordisk Investigational Site
Miami, Florida, United States, 33014
Novo Nordisk Investigational Site
Orlando, Florida, United States, 32806
United States, Tennessee
Novo Nordisk Investigational Site
Knoxville, Tennessee, United States, 37920
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
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)

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00833716     History of Changes
Other Study ID Numbers: NN9535-3616
Study First Received: January 29, 2009
Last Updated: March 31, 2017

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Renal Insufficiency
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on June 23, 2017