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Effect of Alirocumab on Postprandial Hyperlipemia in Patients With Type 2 Diabetes

NCT03344692 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2022-09-27

No results posted yet for this study

Summary

Proprotein convertase subtilisin/kexin type 9 (PCSK9) has emerged over the past decade as a post-transcriptional regulator of the LDL receptor (LDL-R). PCSK9 acts as an endogenous natural inhibitor of the LDL-R pathway. Monoclonal antibodies (mAb) directed against PCSK9, such as Alirocumab, are the most common method of PCSK9 inhibition.

The goal of the present study is to assess, in the context of type 2 diabetes, a situation associated with an increased post-prandial hyperlipemia, whether PCSK9 inhibition with Alirocumab affects postprandial intestinal lipoprotein metabolism.

Conditions

  • Type2 Diabetes

Interventions

DRUG

Alirocumab

prefilled pen containing 75 mg of Praluent (Alirocumab) in 1 ml of solution

OTHER

Placebo

prefilled pen containing 1 ml of solution without Praluent

Sponsors & Collaborators

Principal Investigators

  • Bertrand CARIOU · Nantes University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-12
Primary Completion
2022-04-28
Completion
2022-04-28

Countries

  • France

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03344692 on ClinicalTrials.gov