Clinical trial

CHOlesterol Lowering and Residual Risk in Type 2 Diabetes

Name

19-01964

Description

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.

Trial arms

Trial start

2020-08-12

Estimated PCD

2023-09-25

Trial end

2023-10-19

Status

Completed

Phase

Early phase I

Treatment

Statin

Participants will be given up to 80 mg oral tablets daily for the entire study period preferably at the same time each day.

Arms:

Control group, Type 2 Diabetes group

Other names:

Atorvastatin

PCSK9 inhibitor

Participants will receive 2 injections of 140 mg of PCSK9 inhibitor, one will be administered at baseline visit and the other will be self-administered 2 weeks later at home.

Arms:

Control group, Type 2 Diabetes group

Other names:

Evolocumab, Repatha

Ezetimibe 10mg

Participants who are not able to or not willing to take atorvastatin will be given 10 mg ezetimibe oral tablets daily for the entire study period preferably at the same time each day.

Arms:

Control group, Type 2 Diabetes group

Other names:

Zetia

Size

151

Primary endpoint

Change in platelet activity (MPA) before and after cholesterol reduction

Baseline visit, Follow up visit (4 weeks)

Change in platelet activity (LTA) before and after cholesterol reduction

Follow up visit (4 weeks)

Eligibility criteria

Inclusion Criteria: Subjects with type 2 diabetes: * Age ≥ 18 \& \< 90 * LDL-C \>100mg/dl * Able and willing to provide written informed consent for the study Control subjects without known diabetes: * Age ≥ 18 \& \< 90 * LDL-C \>100mg/dl or lp(a) \>50 mg/dl * Able and willing to provide written informed consent for the study Exclusion Criteria: Subjects with type 2 diabetes: * Established cardiovascular disease on antithrombotic therapy * Triglycerides \>250mg/dl * Use of a PCSK9 inhibitor * HbA1c \>10% * Recent infection in the past 30 days * Any hospitalization in the past 30 days * Use of Immunosuppressive therapy * Use of any antithrombotic therapy * Use of aspirin * Use of NSAID within the past 72 hours * Pregnancy * Anemia (hemoglobin \< 9 g/dl) or thrombocytopenia (Platelet count \<75), or thrombocytosis (Platelet count \>600) * A history of severe bleeding or bleeding disorders * Chronic kidney disease (CrCl \< 30ml/min) Control subjects without known diabetes: * Diabetes (type 1 or type 2) * All other exclusions are identical to the type 2 diabetes group.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 151, 'type': 'ACTUAL'}}

Updated at

2023-10-26

1 organization

3 products

1 indication

Organization

Product

Indication

Product

Product