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Remote And Decentralised Innovative Approaches to Clinical Trials (RADIAL)

NCT05780151 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 107

Last updated 2025-05-29

No results posted yet for this study

Summary

Pan-European proof-of-concept study comparing Decentralised Clinical Trial (DCT) and hybrid approaches to conventional clinical trial approaches in patients with Type 2 diabetes mellitus treated with Toujeo®.

Conditions

  • Diabetes Mellitus, Type 2

Interventions

OTHER

Methodological intervention

All three arms will receive the same clinical intervention but will differ in their level of decentralisation, the methodological intervention.

DRUG

Toujeo

All participants in the study will receive Toujeo® (insulin glargine 300 U/mL). During the treatment period, Toujeo® injection will be administered once daily at the same time as the participant's previous basal insulin was injected, for participant previously treated with once daily injection. In case of previous insulin treatment administered twice a day, the time of injection of Toujeo® will have to be agreed between the physician and the participant before first administration.

Sponsors & Collaborators

  • IMI Trials@Home consortium

    collaborator UNKNOWN

  • Innovative Medicines Initiative

    collaborator OTHER

  • Sanofi

    collaborator INDUSTRY

  • Mira Zuidgeest

    lead OTHER

Principal Investigators

  • Mira GP Zuidgeest, PhD · UMC Utrecht

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-10
Primary Completion
2025-01-21
Completion
2025-01-21

Countries

  • Denmark
  • Germany
  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05780151 on ClinicalTrials.gov