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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02877355
• Other study ID #: NN9924-4267
• Secondary ID: 2015-004534-10U1
• Status: Completed
• Phase: Phase 1
• Start date: August 22, 2016
• Est. completion date: November 24, 2017

Study information

• Verified date: April 2019
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: November 24, 2017
• Est. primary completion date: November 24, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Digestive System Diseases
• Gastrointestinal Diseases

Intervention

Drug:
• semaglutide
All subjects will receive 3 mg oral semaglutide for five days followed by 7 mg oral semaglutide for five days

Locations

Country	Name	City	State
Germany	Novo Nordisk Investigational Site	Mainz
Germany	Novo Nordisk Investigational Site	Neuss

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the semaglutide plasma concentration-time curve		From 0 to 24 hours after the 10th dosing
Secondary	Maximum observed semaglutide plasma concentration		From 0 to 24 hours after the 10th dosing
Secondary	Area under the SNAC plasma concentration-time curve		During a dosing interval (0 to 24 hours) at steady state
Secondary	Maximum observed SNAC plasma concentration		During a dosing interval (0 to 24 hours) at steady state

External Links

•   Clinical Trials at Novo Nordisk