At a glance
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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®
In Brief
A Phase 4 clinical trial evaluating Methodological intervention and Toujeo for Diabetes Mellitus, Type 2. Completed, enrolled 107 participants across 9 sites in 3 countries.
Detailed 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®.
Study Details
Timeline
Interventions
All three arms will receive the same clinical intervention but will differ in their level of decentralisation, the methodological intervention.
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.