Influence of a new medicine on cholesterol and other factors after intake of a meal in patients with diabetes

Phase 1

Conditions: Diabetes mellitus type 2
Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Registration Number: EUCTR2016-003253-15-NL

Lead Sponsor: Franciscus Gasthui

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: Male

Target Recruitment: Not specified

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% - < <9.0%)
- Stable lipid lowering therapy last 2 months (no changes in regiments or dose)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Current smoking
- Impaired renalfunction (MDRD <60 ml/min/1.73 m2)
- Recent cardiovascular event (<6 months) (myocardial infarction, coronary artery bypass grafting, stroke)
- Severe hyperglycemic events in the past 6 months (hyperglycemia >20 mmol/L requiring hospital admittance)
- Recent or current use of pcsk9 antibodies

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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). <br>;Timepoint(s) of evaluation of this end point: After six weeks of treatment

Secondary Outcome Measures

Name	Time	Method
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