Dulaglutide vs conventional treatment. Efficacy of dulaglutide to improve Vascular Health indexes in subjects with Type 2 Diabetes: A Randomized Trial
A randomized trial to once-weekly dulaglutide (1.5 mg) added to traditional antidiabetic treatment compared to traditional treatment alone to evaluate some metabolic efficacy endpoints and surrogate vascular efficacy endpoints such as endothelial function and arterial stiffness indexes.
Methods: Men and women (aged ≥50 years) with established or newly detected type 2 diabetes whose HbA1c was 9.5% or less on stable doses of up to two oral glucoselowering drugs with or without basal insulin therapy were eligible. Subcutaneous dulaglutide was initiated at the full dose (1.5 mg/day weekly). Arterial stiffness indexes ( PWV: pulse wave velocity and augmentation index) and endothelial function index ( RHI : reactive hyperemia index) were evaluated at baseline and at a three-month and nine-month examination visit. At each visit ( at 3 and 9 month follow-up) were also evaluated glycemic variables such as fasting plasma glucose (FPG), HbA1c and lipid variables such as total cholesterol, LDL cholesterol, HDL cholesterol and triglyceride.
Results: at a three month follow up subjects treated with dulaglutide in comparison with subjects treated with conventional therapy showed significantly lower serum levels of FPG and significantly lower percentage of HbA1c. At a 9 month follow up subjects treated with dulaglutide in comparison with control subjects treated with conventional therapy showed significant lower values of mean diastolic blood pressure, BMI, total serum cholesterol, LDL cholesterol, FPG, HbA1c and PWV and higher mean RHI values.
Conclusions: Our randomized trial showed that diabetic subjects treated with conventional therapy plus 1.5 mg subcutaneous dulaglutide in comparison with subjects treated with conventional therapy alone showed favorable metabolic effects that are associated with positive effects on vascular health markers such as arterial stiffness and endothelial function markers. These findings are consistent with previous studies indicating the strict relationship between cardiovascular risk factors such as systolic blood pressure, total serum cholesterol and LDL levels and cardiovascular events and vascular health surrogate markers.