Pharmacokinetics, Safety and Tolerability of Oral Semaglutide in Subjects With Various Degrees of Impaired Renal Function

Novo Nordisk

Status and phase

Completed

Phase 1

Conditions

Healthy

Diabetes

Diabetes Mellitus, Type 2

Treatments

Drug: semaglutide

Study type

Interventional

Funder types

Industry

Identifiers

NCT02014259

U1111-1139-4281 (Other Identifier)

NN9924-4079

2013-000682-36 (EudraCT Number)

Details and patient eligibility

About

This trial is conducted in Europe. The aim of the trial is to investigate the pharmacokinetics (the exposure of the trial drug in the body), safety and tolerability of oral semaglutide in subjects with various degrees of impaired renal function compared to subjects with normal renal function.

Enrollment

71 patients

Sex

All

Ages

18 to 85 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Male or female aged 18-85 years (both inclusive) at the time of signing inform consent
Subject with normal renal function or renal impairment (mild, moderate, severe or end-stage renal disease requiring dialysis)
For subject with normal renal function: good general health (as judged by the investigator)
Body mass index (BMI) 18.5-40.0 kg/m^2 (both inclusive)

Exclusion criteria

Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using adequate contraceptive methods
History of Crohn's disease, ulcerative colitis, or other inflammatory bowel disease
Uncontrolled hypertension (defined as systolic blood pressure above or equal to 180 mmHg and/or diastolic blood pressure above or equal to 100 mmHg)
Any blood draw or donation of blood or plasma in excess of 400 mL within the 3 months preceding the screening visit (Visit 2)
History of significant drug abuse, or a positive drug test at the screening visit (Visit 2)