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

Phase 1

Completed

• Conditions: Diabetes; Diabetes Mellitus, Type 2
• Interventions: Drug: semaglutide

• Registration Number: NCT02877355
• Lead Sponsor: Novo Nordisk A/S

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-08-19
• Study First Submitted QC: 2016-08-19
• Study Start: 2016-08-22
• Study First Posted: 2016-08-24
• Primary Completion: 2017-11-24
• Study Completion: 2017-11-24
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-26
• Last Update Posted: 2019-04-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Semaglutide	semaglutide	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇩🇪 Neuss, Germany