Investigation of the Effect of Upper Gastrointestinal Disease on the Pharmacokinetics of Oral Semaglutide in Subjects With Type 2 Diabetes.
3 other identifiers
interventional
55
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 diabetes
Started Aug 2016
Longer than P75 for phase_1 diabetes
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 19, 2016
CompletedStudy Start
First participant enrolled
August 22, 2016
CompletedFirst Posted
Study publicly available on registry
August 24, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 24, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
November 24, 2017
CompletedApril 29, 2019
April 1, 2019
1.3 years
August 19, 2016
April 26, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Area under the semaglutide plasma concentration-time curve
From 0 to 24 hours after the 10th dosing
Secondary Outcomes (3)
Maximum observed semaglutide plasma concentration
From 0 to 24 hours after the 10th dosing
Area under the SNAC plasma concentration-time curve
During a dosing interval (0 to 24 hours) at steady state
Maximum observed SNAC plasma concentration
During a dosing interval (0 to 24 hours) at steady state
Study Arms (1)
Semaglutide
EXPERIMENTALInterventions
All subjects will receive 3 mg oral semaglutide for five days followed by 7 mg oral semaglutide for five days
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novo Nordisk A/Slead
Study Sites (2)
Novo Nordisk Investigational Site
Mainz, 55116, Germany
Novo Nordisk Investigational Site
Neuss, 41460, Germany
Related Publications (1)
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.
PMID: 33969456DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 19, 2016
First Posted
August 24, 2016
Study Start
August 22, 2016
Primary Completion
November 24, 2017
Study Completion
November 24, 2017
Last Updated
April 29, 2019
Record last verified: 2019-04
Data Sharing
- IPD Sharing
- Will share
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com