Investigation on Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Doses of a Long-acting GLP-1 Analogue in Healthy Male Subjects and Male Subjects With Type 2 Diabetes

NCT01686945 · Completed

Last updated 2026-05-28

This clinical trial is testing the safety and effects of multiple doses of a long-acting GLP-1 medicine in healthy men and men with type 2 diabetes.

Status Completed The study has finished.

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

Type Interventional (clinical trial)

Design Randomized, double-blind treatment study

Participants 107 people

Who can join Ages 18–64 · male only Healthy volunteers accepted.

Timeline Started 2012-09 · est. completion 2013-04

Where 1 site · Germany

What this study is testing ClinicalTrials.gov NCT01686945 ↗

Description as written by the study sponsor.

This trial is conducted in Europe. The aim of the trial is to investigate safety, tolerability, pharmacokinetics (the exposure of the trial drug in the body), and pharmacodynamics (the effect of the investigated drug on the body) of multiple doses of a long-acting GLP-1 analogue (oral semaglutide) and a carrier in healthy male subjects and male subjects with type 2 diabetes (T2D).

Treatments tested

semaglutide Drug

Start doses of 5 mg and 10 mg with end dose of 20 mg. For oral administration.
semaglutide Drug

Start doses of 5 mg and 10 mg with end doses of either 20 mg or 40 mg. For oral administration.
semaglutide Drug

Start doses of 5 mg and 10 mg with end doses of either 20 mg, 40 mg or 60 mg. For oral administration.
placebo Drug

Placebo semaglutide. For oral administration.
placebo Drug

Placebo semaglutide with carrier. For oral administration.

Main thing measured	Number of treatment emergent adverse events (TEAEs) recorded
Sponsor	Novo Nordisk A/S
Conditions studied	Diabetes, Diabetes Mellitus, Type 2, Healthy
GLP-1 drugs	—

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT01686945 ↗