DIABETES Mellitus Type 2 Not Well Controlled Clinical Trial
Official title:
Differences in Endothelial Function Amongst Sitagliptin and Liraglutide Users: A Randomized, Open-label, Parallel-group and Active Controlled Trial
Differences in endothelial function amongst Sitagliptin and Liraglutide Users. A randomized, open-label, parallel-group and active controlled trial
Randomized, open-label, parallel-group, active controlled, phase IV study to assess the
efficacy and safety of a 3 month treatment period with Liraglutide to Sitagliptin in type 2
diabetes patients not well controlled at the maximum tolerated dose of metformin.The study
has been designed with a random design as it is one of the most important techniques for
avoiding bias in clinical trials. The study will follow a parallel group, open-label design
as liraglutide is administered by subcutaneous injection and sitagliptin orally in tablets.
A double-dummy design has been rejected because it is highly complicated in a phase IV
study, and any bias of an open-label design has a lower impact on objective variables (as it
is our primary endpoint) and it could be compensated with the proposed random
design.Sitagliptin has been selected as the active control as it is one of the prescribed
treatments for type 2 diabetes patients not well controlled at the maximum tolerated dose of
metformin.
The study objectives will be assessed after 3 months of therapy as it is considered a
suitable timing for identifying short-term changes on flow-mediated vasodilation
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment