drugset / Trial / NCT04369664

CHOlesterol Lowering and Residual Risk in Type 2 Diabetes

NCT04369664

Phase 4 Completed 151 enrolled NYU Langone Health
Non-randomizedSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to investigate why individuals with type 2 diabetes are at increased risk for heart disease and stroke. This study will investigate risk factors for heart disease and stroke, including platelet (involved in clotting) activity, inflammation, blood vessel wall function, and genetic information (blueprints of your cells), in participants with type 2 diabetes and elevated cholesterol. This study will also include a control group - subjects with elevated cholesterol who do not have diabetes. All participants will be given cholesterol-lowering medicines (PCSK9 inhibitor and statin or ezetimibe) for 1 month with the same risk factors being measured following cholesterol reduction. This study will help understand why individuals with type 2 diabetes are at higher risk for heart disease and stroke before and even after cholesterol reduction.

Timeline

Start
2020-08-12
Primary completion
2023-09-25
Completion
2023-10-19

Drugs

EvaluationDrugModalityDoseRoute
Subject Atorvastatin Small molecule 80 mg Oral
Subject Evolocumab Monoclonal antibody 140 mg
Subject Ezetimibe Unknown 10 mg Oral