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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)
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Novo Nordisk Investigational Site
Anniston, Alabama, United States
Novo Nordisk Investigational Site
Birmingham, Alabama, United States
Novo Nordisk Investigational Site
Fountain Hills, Arizona, United States
Novo Nordisk Investigational Site
Glendale, Arizona, United States
Novo Nordisk Investigational Site
Mesa, Arizona, United States
Novo Nordisk Investigational Site
Phoenix, Arizona, United States
Novo Nordisk Investigational Site
Tucson, Arizona, United States
Novo Nordisk Investigational Site
Tucson, Arizona, United States
Novo Nordisk Investigational Site
Anaheim, California, United States
Novo Nordisk Investigational Site
Fresno, California, United States
Start Date
February 2, 2017
Primary Completion Date
January 18, 2018
Completion Date
August 22, 2018
Last Updated
March 2, 2020
731
ACTUAL participants
semaglutide
DRUG
semaglutide
DRUG
semaglutide
DRUG
placebo
DRUG
Lead Sponsor
Novo Nordisk A/S
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT07296484