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Completed Phase 3 Interventional Results available

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

ClinicalTrials.gov ID: NCT03021187

Public ClinicalTrials.gov record NCT03021187. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 2, 2026, 5:42 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Efficacy and Safety of Oral Semaglutide Versus Placebo in Subjects With Type 2 Diabetes Mellitus Treated With Insulin. A 52-week, Randomised, Double-blind, Placebo-controlled Trial (PIONEER 8 - Insulin add-on)

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT03021187
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Novo Nordisk A/S
Industry
Enrollment
731 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Feb 1, 2017
Primary completion
Jan 17, 2018
Completion
Aug 21, 2018
Last update posted
Mar 1, 2020

2017 – 2018

United States locations

U.S. sites
50
U.S. states
23
U.S. cities
47
Facility City State ZIP Site status
Novo Nordisk Investigational Site Anniston Alabama 36207
Novo Nordisk Investigational Site Birmingham Alabama 35211
Novo Nordisk Investigational Site Fountain Hills Arizona 85268
Novo Nordisk Investigational Site Glendale Arizona 85308
Novo Nordisk Investigational Site Mesa Arizona 85213
Novo Nordisk Investigational Site Phoenix Arizona 85037
Novo Nordisk Investigational Site Tucson Arizona 85723-0001
Novo Nordisk Investigational Site Tucson Arizona 85741
Novo Nordisk Investigational Site Anaheim California 92801
Novo Nordisk Investigational Site Fresno California 93720
Novo Nordisk Investigational Site Los Angeles California 90017
Novo Nordisk Investigational Site Los Angeles California 90057
Novo Nordisk Investigational Site Riverside California 92506
Novo Nordisk Investigational Site Van Nuys California 91405
Novo Nordisk Investigational Site Vista California 92083
Novo Nordisk Investigational Site Colorado Springs Colorado 80904
Novo Nordisk Investigational Site Denver Colorado 80246
Novo Nordisk Investigational Site Hialeah Florida 33016
Novo Nordisk Investigational Site Atlanta Georgia 30342
Novo Nordisk Investigational Site Chicago Illinois 60607
Novo Nordisk Investigational Site Franklin Indiana 46131
Novo Nordisk Investigational Site Lexington Kentucky 40503
Novo Nordisk Investigational Site Paducah Kentucky 42003
Novo Nordisk Investigational Site Metairie Louisiana 70002
Novo Nordisk Investigational Site Natchitoches Louisiana 71457-5881
Novo Nordisk Investigational Site Hyattsville Maryland 20782
Novo Nordisk Investigational Site Rockville Maryland 20852
Novo Nordisk Investigational Site Boston Massachusetts 02215
Novo Nordisk Investigational Site Troy Michigan 48098
Novo Nordisk Investigational Site Henderson Nevada 89052-2649
Novo Nordisk Investigational Site Las Vegas Nevada 89148
Novo Nordisk Investigational Site West Seneca New York 14224
Novo Nordisk Investigational Site Asheville North Carolina 28803
Novo Nordisk Investigational Site Chapel Hill North Carolina 27517
Novo Nordisk Investigational Site Cincinnati Ohio 45245
Novo Nordisk Investigational Site Dayton Ohio 45439
Novo Nordisk Investigational Site Beaver Pennsylvania 15009
Novo Nordisk Investigational Site Lansdale Pennsylvania 19446-1002
Novo Nordisk Investigational Site Summerville South Carolina 29485
Novo Nordisk Investigational Site Chattanooga Tennessee 37411
Novo Nordisk Investigational Site Kingsport Tennessee 37660-4652
Novo Nordisk Investigational Site Austin Texas 78731
Novo Nordisk Investigational Site Dallas Texas 75251
Novo Nordisk Investigational Site Dallas Texas 75390-9302
Novo Nordisk Investigational Site Houston Texas 77090
Novo Nordisk Investigational Site Mesquite Texas 75149
Novo Nordisk Investigational Site Midland Texas 79707
Novo Nordisk Investigational Site Round Rock Texas 78681
Novo Nordisk Investigational Site Murray Utah 84123
Novo Nordisk Investigational Site Winchester Virginia 22601

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 68 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT03021187, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Mar 1, 2020 · Synced Sep 2, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT03021187 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →