Effect of Alirocumab on Postprandial Hyperlipemia in Patients With Type 2 Diabetes (NCT03344692) | Clinical Trial Compass
CompletedPhase 3
Effect of Alirocumab on Postprandial Hyperlipemia in Patients With Type 2 Diabetes
France22 participantsStarted 2019-02-12
Plain-language 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.
Who can participate
Age range
18 Years – 75 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Men with type 2 diabetes diagnosed since ≥ 6 months
* HbA1C \<9.0%
* Men with primary hypercholesterolemia and/or mixed dyslipidemia
* Aged 18-75 years (limits inclusive)
* Patient could be treated for type 2 diabetes when diet and physical activity are not sufficient to restore glycemic control. The treatment must be stable 1 month before the inclusion and have to remain unchanged all along the study. The only authorized treatments are:
* Metformin
* And/or Sulphonylureas (SUs)
* And/or Repaglinide
* And/or DPP-4 inhibitors
* And/or GLP1 receptor agonists: exenatide, liraglutide, dulaglutide
* Fasting serum TG ≥ 150 mg/dl and \< 500 mg/dl
* BMI: 20-45 kg/m2
* Use of statins or ezetimibe is allowed if treatment is stable for ≥ 1 month before the screening
Exclusion Criteria:
* Any secondary causes of hypercholesterolemia or of mixed dyslipidemia (nephrotic syndrome, hypothyroidism…)
* impaired liver function (AST and/or ALT ≥ 3ULN)
* impaired renal function (eGFR with CKD-EPI formula \< 30 ml/min)
* Alcohol abuse (\> 2 standard alcoholic drink per day; 1 standard alcoholic drink is the equivalent of 10g of alcohol)
* History of myocardial infarction, acute coronary syndrome, unstable angina pectoris, stroke, transient ischemic attack, or cardiac revascularization within the 6 months before the screening visit.
* History of PCSK9 mAb use
* Known sensitivity to monoclonal antibody therapeutics or to their excipients
* Lipid lowering therapies (other tha…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Total area under the post-prandial triglycerides concentration-time curve from meal-time until 8h (AUC0-8h) after standardized high fat meal.
Timeframe: During 8 hours at week 10 after first treatment injection