Protocol Section

Protocol Section

The Protocol Section is one of the main sections in ClinicalTrials.gov data structure. It contains protocol-related information for clinical trials, including identification, status, design, eligibility, and other key details about how the trial is structured and conducted.

Protocol Section path is as follows:

Study -> Protocol Section -> Protocol Modules (Identification, Status, Design, Eligibility, etc.)

Protocol Section


Ignite Creation Date: 2025-12-24 @ 10:47 PM
Ignite Modification Date: 2025-12-24 @ 10:47 PM
NCT ID: NCT03703869
Description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
Study: NCT03703869
Study Brief: Twelve -Month Study Observing How Insulin-naïve Patients With Type 2 Diabetes Mellitus Manage Diabetes Using Toujeo® After Oral Antidiabetic Drug Failure, the Side Effect of Toujeo®, and The Cost.