Efficacy and Safety of Oral Semaglutide Versus Placebo in Subjects With Type 2 Diabetes Mellitus Treated With Insulin

NCT03021187 · Completed

Last updated 2026-05-28

This clinical trial tested whether an oral medication called semaglutide, compared to a placebo, could help lower blood sugar levels in adults with type 2 diabetes who were already using insulin.

Status Completed The study has finished.

Phase Phase 3 Confirms effectiveness in a large group before approval.

Type Interventional (clinical trial)

Design Randomized, double-blind treatment study

Participants 731 people

Who can join Ages 18+ · all sexes

Timeline Started 2017-02 · est. completion 2018-08

Where 118 sites · Canada, France, Greece, India, Japan, Mexico, Poland, Puerto Rico, Russia, United States

What this study is testing ClinicalTrials.gov NCT03021187 ↗

Description as written by the study sponsor.

This trial is conducted globally. The aim of the trial is to investigate the efficacy and safety of oral semaglutide versus placebo in subjects with Type 2 Diabetes Mellitus treated with insulin. All subjects should continue their pre-trial insulin therapy (basal, basal-bolus or premixed regimen including combinations of soluble insulins) throughout the trial. Subjects treated with metformin in addition to insulin treatment must continue their metformin treatment throughout the entire trial.

Treatments tested

semaglutide Drug

Oral semaglutide administered once-daily for 52 weeks as an add-on to the subjects' pre-trial insulin treatment
semaglutide Drug

Oral semaglutide (3 mg followed by 7 mg) administered once-daily for 52 weeks as an add-on to the subjects' pre-trial insulin treatment
semaglutide Drug

Oral semaglutide (3 mg followed by 7 mg and finally 14 mg) administered once-daily for 52 weeks as an add-on to the subjects' pre-trial insulin treatment
placebo Drug

Oral semaglutide placebo administered once-daily for 52 weeks as an add-on to the subjects' pre-trial insulin treatment

Main thing measured	Change in HbA1c (Week 26)
Sponsor	Novo Nordisk A/S
Conditions studied	Diabetes, Diabetes Mellitus, Type 2
GLP-1 drugs	semaglutide

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT03021187 ↗