Diabetes, Diabetes Mellitus, Type 2, Renal Impairment
Conditions
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.
Interventions
DRUGsemaglutide
10 mg/mL of semaglutide solution for s.c. injection, single dose
Sponsors
Novo Nordisk A/S
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AUC of NN9535 | at 21 days |
Secondary
| Measure | Time frame |
|---|---|
| Laboratory safety, adverse events | at 21 days |
Countries
United States
Outcome results
None listed