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

NCT02249910 · Completed

Last updated 2026-05-28

This clinical trial is testing how a diabetes medication called oral semaglutide affects the levels of metformin and digoxin in the blood of healthy adults.

Status Completed The study has finished.

Phase Phase 1 Checks safety and dosing in a small group.

Type Interventional (clinical trial)

Design Non-randomized, open-label (no blinding) treatment study

Participants 32 people

Who can join Ages 18–75 · all sexes Healthy volunteers accepted.

Timeline Started 2014-09 · est. completion 2015-03

Where 1 site · Germany

What this study is testing ClinicalTrials.gov NCT02249910 ↗

Description as written by the study sponsor.

This trial is conducted in Europe. The aim of this trial is to investigate the influence of oral semaglutide on pharmacokinetics (the exposure of the trial drug in the body) of metformin and digoxin in healthy subjects.

Treatments tested

semaglutide Drug

Oral administration of 5 mg daily for one week, then escalated to 10 mg daily for one week, followed by escalation to 20 mg daily for 41 days
metformin Drug

Oral administration of 850 mg twice daily for 3 days followed by 850 mg on day 4, assessed in 3 dosing periods 1) alone, 2) co-administration with SNAC (sodium N-\[8-(2-hydroxybenzoyl) amino\] caprylate) and 3) co-administration with oral semaglutide.
digoxin Drug

Oral administration of 0.5 mg single dose, assessed in 3 dosing periods 1) alone, 2) co-administration with SNAC (sodium N-\[8-(2-hydroxybenzoyl) amino\] caprylate) and 3) co-administration with oral semaglutide.
placebo Drug

Oral administration of SNAC 300 mg. Will be administered with the morning dose of metformin (1st, 3rd, 5th and 7th dose). On Day 24, a single SNAC dose will be administered with digoxin.

Main thing measured	Area under the metformin plasma concentration-time curve
Sponsor	Novo Nordisk A/S
Conditions studied	Diabetes, Healthy
GLP-1 drugs	semaglutide

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT02249910 ↗