Clinical trial NCT02877355: Investigation of the Effect of Upper Gastrointestinal Disease on the Pharmacokinetics of Oral Semaglutide in Subjects With Type 2 Diabetes.
Official title: Investigation of the Effect of Upper Gastrointestinal Disease on the Pharmacokinetics of Oral Semaglutide in Subjects With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2016-08-24
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This trial is conducted in Europe. The aim of this trial is, to investigate the effect of upper gastrointestinal disease on the pharmacokinetics (the exposure of the trial drug in the body) of oral semaglutide in subjects with type 2 diabetes.


Eligibility criteria: Inclusion Criteria:

* Male or female, aged 18-80 years (both inclusive) at the time of signing informed consent
* Body mass index (BMI) between 18.5-39.9 kg/m\^2 (both inclusive)
* Subjects diagnosed clinically with type 2 diabetes mellitus for at least 180 days prior to the first screening visit
* For subjects with upper gastrointestinal (GI) disease: Diagnosed with chronic gastritis and/or gastroesophageal reflux disease (GERD) at screening

Exclusion Criteria:

* Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using a highly effective contraceptive method (adequate contraceptive measures as required by local regulation or practice). (Highly effective contraceptive methods are considered those with a failure rate less than 1% undesired pregnancies per year including surgical sterilisation, hormonal intrauterine devices (coil), oral hormonal contraceptives, sexual abstinence or a surgically sterilised partner)
* History of pancreatitis (acute or chronic)
* History of major surgical procedures involving the stomach potentially affecting absorption of trial product (e.g. subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass surgery)
* Unable or unwilling to refrain from smoking during the in-patient periods
* Any blood draw in excess of 50 mL in the past 30 days, or donation of blood or plasma in excess of 400 mL within 90 days of the first screening visit

Primary outcomes:
measure: Area under the semaglutide plasma concentration-time curve
timeFrame: From 0 to 24 hours after the 10th dosing
Secondary outcomes:
measure: Maximum observed semaglutide plasma concentration
timeFrame: From 0 to 24 hours after the 10th dosing
measure: Area under the SNAC plasma concentration-time curve
timeFrame: During a dosing interval (0 to 24 hours) at steady state
measure: Maximum observed SNAC plasma concentration
timeFrame: During a dosing interval (0 to 24 hours) at steady state
Other outcomes:
Locations:
city: Mainz
country: Germany
facility: Novo Nordisk Investigational Site
city: Neuss
country: Germany
facility: Novo Nordisk Investigational Site
Study officials:
References:
citation: Overgaard RV, Navarria A, Ingwersen SH, Baekdal TA, Kildemoes RJ. Clinical Pharmacokinetics of Oral Semaglutide: Analyses of Data from Clinical Pharmacology Trials. Clin Pharmacokinet. 2021 Oct;60(10):1335-1348. doi: 10.1007/s40262-021-01025-x. Epub 2021 May 10.