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

What Was Tested

In this phase 1 trial, researchers set out to test Semaglutide.

This trial is conducted in Europe.

It had 1 arm (groups): Semaglutide (experimental).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 55 actual participants took part.

It was open to people of any sex aged from 18 years up to 80 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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.

The full record lists 4 inclusion and 5 exclusion criteria; among the exclusions: 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.

How the Study Was Run

It was run as a single-group and open-label study.

Being open-label, the Semaglutide study did not mask who received what.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2016-08-22 with completion listed for 2017-11-24.

It ran at 2 sites in Germany (2).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Area under the semaglutide plasma concentration-time curve.

It also tracked 3 secondary outcomes, for example Maximum observed semaglutide plasma concentration, Area under the SNAC plasma concentration-time curve and Maximum observed SNAC plasma concentration.

What This Means in Plain Language

Put simply, this is a phase 1 trial of Semaglutide in 55 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Semaglutide compound page, all human trials.