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

April 26, 2019 updated by: Novo Nordisk A/S

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

55

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 22, 2016

Primary Completion (Actual)

November 24, 2017

Study Completion (Actual)

November 24, 2017

Study Registration Dates

First Submitted

August 19, 2016

First Submitted That Met QC Criteria

August 19, 2016

First Posted (Estimate)

August 24, 2016

Study Record Updates

Last Update Posted (Actual)

April 29, 2019

Last Update Submitted That Met QC Criteria

April 26, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN9924-4267
  • 2015-004534-10 (EudraCT Number)
  • U1111-1175-5246 (Other Identifier: WHO)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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