Investigating the Influence of Oral Semaglutide on Pharmacokinetics of Metformin and Digoxin in Healthy Subjects

What Was Tested

This registered phase 1 trial tested 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: 32 actual participants took part.

It was open to people of any sex aged from 18 years up to 75 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Male or female, age 18-75 years (both inclusive) at the time of signing inform consent. Body mass index (BMI) 20.0-29.9 kg/m\^2 (both inclusive). A good general health based on medical history, physical examination, and results of vital signs, electrocardiogram and laboratory safety tests performed during the screening visit, as judged by the investigator.

The full record lists 3 inclusion and 4 exclusion criteria; among the exclusions: history of crohn's disease, ulcerative colitis, or other inflammatory bowel disease.

How the Study Was Run

The set-up was non-randomized, crossover and open-label.

In the crossover set-up each of the participants took both Semaglutide and the comparison in turn, acting as their own control.

Nothing was hidden in this open-label Semaglutide study: the participants and staff both knew the treatment.

It started in 2014-09-18 with completion listed for 2015-03-06.

It ran at 1 site in Germany.

Its stated primary purpose is treatment.

What Was Measured

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

It also tracked 5 secondary outcomes, for example Maximum observed metformin plasma concentration, Maximum observed digoxin plasma concentration, Maximum observed semaglutide plasma concentration, Area under the SNAC plasma concentration-time curve and Number of hypoglycaemic episodes.

What This Means in Plain Language

Put simply, this is a phase 1, non-randomized trial of Semaglutide in 32 people.

Its size is small, so on its own it can only give an early look.

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.