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Efficacy and Safety of Oral Semaglutide Versus Placebo in Subjects With Type 2 Diabetes Mellitus Treated With Insulin - Trial NCT03021187

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.

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NCT03021187
Phase 3
Completed
drug
Trial Details
ClinicalTrials.gov • NCT03021187
View on ClinicalTrials.gov
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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)

Study Focus

semaglutide

Interventional

drug

Sponsor & Location

Novo Nordisk A/S

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 3

Feb 02, 2017

Aug 22, 2018

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 mellitus
Type 2 diabetes mellitus with other specified complications
Type 2 diabetes mellitus with unspecified complications
Type 2 diabetes mellitus without complications
Type 2 diabetes mellitus with multiple complications

Data Source

ClinicalTrials.gov

NCT03021187

Non-Device Trial