CompletedNCT02877355Updated Apr 29, 2019

Investigation of the Effect of Upper Gastrointestinal Disease on the Pharmacokinetics of Oral Semaglutide in Subjects With Type 2 Diabetes.

A Phase 1 interventional study of semaglutide in Diabetes and Diabetes Mellitus, Type 2, sponsored by Novo Nordisk A/S. Completed at 2 sites in Germany. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2019-04-29.

Sponsored by Novo Nordisk A/S · Phase 1, Interventional, and Treatment

Phase: Phase 1
Study type: Interventional
Enrollment: 55
Allocation: Not applicable
Ages: 18 Years to 80 Years
Sex: All

Study 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.

Conditions studied

Diabetes
Diabetes Mellitus, Type 2

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In context

Gastrointestinal Diseases

628 studies on the registry are indexed under Gastrointestinal Diseases; 128 are open to participants now.

This study's enrollment of 55 is below the median of 77 across 422 interventional studies indexed under Gastrointestinal Diseases.

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Lead sponsor

Novo Nordisk A/S is the lead sponsor of 1,370 studies on the registry; 102 are open to participants now.

Of its 198 completed or terminated interventional studies of FDA-regulated products, 94 (47%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 80 Years
Sexes eligible: All
Accepts healthy volunteers: No

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

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

Study design

Phase: Phase 1
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 55 participants (actual)

Study arms

Experimental
Semaglutide
Drug: semaglutide

Interventions

Drugsemaglutide
All subjects will receive 3 mg oral semaglutide for five days followed by 7 mg oral semaglutide for five days

What researchers measure

Primary outcomes

Area under the semaglutide plasma concentration-time curve
Time frame: From 0 to 24 hours after the 10th dosing

Secondary outcomes

Maximum observed semaglutide plasma concentration
Time frame: From 0 to 24 hours after the 10th dosing
Area under the SNAC plasma concentration-time curve
Time frame: During a dosing interval (0 to 24 hours) at steady state
Maximum observed SNAC plasma concentration
Time frame: During a dosing interval (0 to 24 hours) at steady state

Study locations

2 sites

Novo Nordisk Investigational Site
Mainz, 55116, Germany
Novo Nordisk Investigational Site
Neuss, 41460, Germany

References and documents

Publications

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. PubMed 33969456 ↗

Individual participant data

Plan to share: Yes — According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Apr 29, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02877355
Lead sponsor: Novo Nordisk A/S
Responsible party: Sponsor
First posted: Aug 24, 2016
Start date: Aug 22, 2016
Primary completion: Nov 24, 2017
Completion: Nov 24, 2017
Last update: Apr 29, 2019

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.

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