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NCT03021187Completed

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

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)
Novo Nordisk A/SPhase 3ClinicalTrials.govdrug
Study focus
Drug/Device/Intervention
semaglutide
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Novo Nordisk A/S
Location
Anniston,Birmingham,Fountain Hills,Glendale,Mesa,Phoenix,Tucson,Tucson,Anaheim,Fresno,Los Angeles,Los Angeles,Riverside,Van Nuys,Vista,Colorado Springs,Denver,Hialeah,Atlanta,Chicago,Franklin,Lexingto, Canada,France,Greece,India,Japan,Mexico,Poland,Puerto Rico,Russian Federation,United States of Ameri
Timeline & enrollment
Phase
Phase 3
Start date
Feb 02, 2017
End date
Aug 22, 2018
Enrollment
731 participants
Primary outcome

Change in HbA1c (Week 26)

Summary

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.

ICD-10 classifications
Type 2 diabetes mellitusType 2 diabetes mellitus with other specified complicationsType 2 diabetes mellitus with unspecified complicationsType 2 diabetes mellitus without complicationsType 2 diabetes mellitus with multiple complications
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT03021187
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT03021187 through Pure Global AI's free database. This Phase 3 trial is sponsored by Novo Nordisk A/S and is currently Completed. The study focuses on Diabetes,Diabetes Mellitus, Type 2. Target enrollment is 731 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.