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

• Sponsor: Novo Nordisk A/S (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02877355
• Collaborator: (none)
• Enrollment: 55
• Locations: 2
• Arm: 1
• Actual Duration (Months): 15.1
• Patients Per Site: 27.5
• Patients Per Site Per Month: 1.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes; Diabetes Mellitus, Type 2	Drug: semaglutide	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 55 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Investigation of the Effect of Upper Gastrointestinal Disease on the Pharmacokinetics of Oral Semaglutide in Subjects With Type 2 Diabetes
• Actual Study Start Date: Aug 22, 2016
• Actual Primary Completion Date: Nov 24, 2017
• Actual Study Completion Date: Nov 24, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Semaglutide	Drug: semaglutide; All subjects will receive 3 mg oral semaglutide for five days followed by 7 mg oral semaglutide for five days

Outcome Measures

Primary Outcome Measures

1. Area under the semaglutide plasma concentration-time curve [From 0 to 24 hours after the 10th dosing]

Secondary Outcome Measures

1. Maximum observed semaglutide plasma concentration [From 0 to 24 hours after the 10th dosing]

2. Area under the SNAC plasma concentration-time curve [During a dosing interval (0 to 24 hours) at steady state]

3. Maximum observed SNAC plasma concentration [During a dosing interval (0 to 24 hours) at steady state]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: 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:

• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Novo Nordisk Investigational Site	Mainz		Germany	55116
2	Novo Nordisk Investigational Site	Neuss		Germany	41460

Sponsors and Collaborators

• Novo Nordisk A/S

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Clinical Trials at Novo Nordisk

Publications

None provided.

• Responsible Party: Novo Nordisk A/S
• ClinicalTrials.gov Identifier: NCT02877355
• Other Study ID Numbers: NN9924-4267; 2015-004534-10; U1111-1175-5246
• First Posted: Aug 24, 2016
• Last Update Posted: Apr 29, 2019
• Last Verified: Apr 1, 2019

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Gastrointestinal Diseases; Digestive System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2

Study Results

No Results Posted as of Apr 29, 2019