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

Sponsor
Nantes University Hospital
Study ID
NCT03344692
Phase
PHASE3
Status
Completed

Conditions

  • Type2 Diabetes

Eligibility Criteria

Sex
MALE
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Alirocumab — DRUG
    prefilled pen containing 75 mg of Praluent (Alirocumab) in 1 ml of solution
  • Placebo — OTHER
    prefilled pen containing 1 ml of solution without Praluent

Study Details

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.

Key Dates

Start date
Feb 12, 2019
Status verified
Sep 2022
Primary completion
Apr 28, 2022
Completion
Apr 28, 2022

Study Design

Enrollment
22 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Alirocumab
    Alirocumab 75 mg for subcutaneous injection via a pre-filled pen. One injection every 2 weeks during a 10-weeks period (5 injections in total)
  • Placebo Comparator: Placebo
    Placebo matching alirocumab is prepared in the same formulation as alirocumab, without the addition of protein, for subcutaneous injection via a pre-filled pen. One injection every 2 weeks during a 10-weeks period (5 injections in total)

Primary Outcome Measure

Total area under the post-prandial triglycerides concentration-time curve from meal-time until 8h (AUC0-8h) after standardized high fat meal. [ Time Frame: During 8 hours at week 10 after first treatment injection ]

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