Diabetes Mellitus, Type 2 Clinical Trial
Official title:
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®
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®.
The proposed study has been designed to compare the scientific and operational quality of fully decentralised and hybrid approaches to a conventional clinical trial approach and evaluate the feasibility of such approaches. The primary study objectives are to (1) assess potential benefits of a DCT approach on participant recruitment, retention, diversity, site and participant satisfaction, and cost and (2) to determine acceptability of a DCT approach by measuring variables related to safety oversight, treatment adherence and data quality (missing data and query rate) within the arms that have a different degree of decentralisation. The secondary study objective is to determine whether the efficacy of treatment with Toujeo® (insulin glargine 300 U/mL) is within the accepted range within the arms with different degree of decentralisation. The design is a parallel-group, open-label, multi-centre study in Europe for patients with Type 2 diabetes mellitus ( T2DM) with glycated haemoglobin (HbA1c) between 7% and 10% and treated with basal insulin as part of their glucose-lowering treatment. The study consists of 2 parts with 3 different arms. Part A has site-based recruitment followed by a 1:1 randomization into a conventional arm and a hybrid arm. Part B has decentralised recruitment, no randomization and consists of a fully remote arm. The study will enrol approximately 150 adults in each site-based arm (conventional and hybrid) and approximately 300 in the remote arm, for a total of 600 participants in approximately 5-6 countries. Both Part A and Part B will consist of a screening period (3-6 weeks), a treatment period with open-label Toujeo® (24 weeks) and a follow-up period (2-4 days after end of treatment [EOT]). ;
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