Diabetes mellitus type 2
Conditions
Interventions
Trade Name: Praluent
Pharmaceutical Form: Solution for injection in pre-filled pen
Pharmaceutical form of the placebo: Solution for injection in pre-filled pen
Route of administration of the placebo:
Sponsors
Franciscus Gasthui
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: - Age of 18 years or older - Male - Fasting triglycerides levels between 1.8 mmol/L and 7.0 mmol/L - Diabetes mellitus type 2 on intensive insulin treatment (three times short acting and one daily long acting) (unchanges for >10 weeks prior to consent) - Stable glucose regulation last 6 months (HbA1c >6.5% - =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Current smoking - Impaired renalfunction (MDRD 20 mmol/L requiring hospital admittance) - Recent or current use of pcsk9 antibodies
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To explore the inflammatory changes of a PCSK-9 inhibitor compared with placebo on postprandial leukocyte activationin men with type 2 diabetes mellitus.;Secondary Objective: To explore the inflammatory changes of a PCSK-9 inhibitor compared with placebo on postprandial lipemia , oxidative stress and endothelial function in men with type 2 diabetes mellitus;Primary end point(s): Primary end point will be the effect of alirocumab on postprandial leukocyte activation makers (CD11b, CD66b, CD35 and CD36). ;Timepoint(s) of evaluation of this end point: After six weeks of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary endpoints will be the effect of alirocumab on postprandial lipemie (plasme apo B, plasma total apo B, HDL-c and triglycerides), oxidative stress and vascular function.;Timepoint(s) of evaluation of this end point: After six weeks of treatment | — |
Countries
Netherlands
Contacts
Public ContactB. Burggraaf
Franciscus Gasthuis
Outcome results
None listed