Clinical trial NCT02014259: Pharmacokinetics, Safety and Tolerability of Oral Semaglutide in Subjects With Various Degrees of Impaired Renal Function
Official title: Investigation of Pharmacokinetics, Safety and Tolerability of Oral Semaglutide in Subjects With Various Degrees of Impaired Renal Function Compared to Subjects With Normal Renal Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes
Diabetes Mellitus, Type 2
Healthy
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2013-12-18
Enrollment: 71
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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)

Primary outcomes:
measure: Area under the semaglutide plasma concentration time curve
timeFrame: From time 0 to 24 hours after the 10th dosing
Secondary outcomes:
measure: Maximum observed semaglutide plasma concentration
timeFrame: 0 to 24 hours after the 10th dosing
measure: Area under the SNAC (Sodium N-[8-(2-hydroxybenzoyl) amino] caprylate /salcaprozate sodium) plasma concentration time curve
timeFrame: From time 0 to 24 hours after the 10th dosing
measure: Maximum observed SNAC plasma concentration
timeFrame: 0 to 24 hours after the 10th dosing
Other outcomes:
Locations:
city: Hradec Králové
country: Czechia
facility: Novo Nordisk Investigational Site
city: Praha 7
country: Czechia
facility: Novo Nordisk Investigational Site
city: Budapest
country: Hungary
facility: Novo Nordisk Investigational Site
city: Budapest
country: Hungary
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: Granhall C, Sondergaard FL, Thomsen M, Anderson TW. Pharmacokinetics, Safety and Tolerability of Oral Semaglutide in Subjects with Renal Impairment. Clin Pharmacokinet. 2018 Dec;57(12):1571-1580. doi: 10.1007/s40262-018-0649-2.