Participants must also have cardiovascular risk factors and moderately impaired kidney function.
The SCORED Trial is a phase III clinical trial designed to show if the study drug does not increase the risk of having a cardiovascular event, such as heart attack or stroke, in patients with Type 2 Diabetes and kidney disease.
The trial will also study if the study drug can instead decrease the risk of these events. Eligible patients must also have cardiovascular risk factors and moderately impaired kidney function. Patients will be randomly selected to receive the study drug or placebo, which is a tablet that looks like the study drug, but does not contain the active drug ingredient.
Additional requirements will be discussed with a study representative. Qualified patients will receive study-related care at no cost.
Participation in the SCORED Trial consists of three periods:
SCREENING - to determine eligibility to participate
TREATMENT - receive either the study drug or placebo
FOLLOW-UP - final procedures/assessments
The duration of treatment (investigational drug or placebo) will be approximately 27-51 months and will include a follow-up time period. There will be 6 on-site visits within the first six months and then one on-site visit every 26 weeks until the completion of the study.