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Completed

NCT Number: NCT02877355

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Novo Nordisk Investigational Site, Mainz, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

semaglutide

Drug

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

Primary outcomes

  1. Area under the semaglutide plasma concentration-time curve

    Time frame: From 0 to 24 hours after the 10th dosing

Secondary outcomes

  1. Maximum observed semaglutide plasma concentration

    Time frame: From 0 to 24 hours after the 10th dosing

  2. Area under the SNAC plasma concentration-time curve

    Time frame: During a dosing interval (0 to 24 hours) at steady state

  3. Maximum observed SNAC plasma concentration

    Time frame: During a dosing interval (0 to 24 hours) at steady state

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Aug 24, 2016
Registry last updated
Apr 29, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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