Effect of Renal Impairment on the Pharmacokinetics of NN9535

Novo Nordisk

Status and phase: Completed; Phase 1

Conditions: Renal Impairment; Diabetes; Diabetes Mellitus, Type 2

Treatments: Drug: semaglutide

Study type: Interventional

Funder types: Industry

Identifiers

NCT00833716

NN9535-3616

Details and patient eligibility

About

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.

Enrollment: 62 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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62 participants in 1 patient group

A

Experimental group

Treatment:

Drug: semaglutide