Status:
COMPLETED
Effect of Alirocumab on Postprandial Hyperlipemia in Patients With Type 2 Diabetes
Lead Sponsor:
Nantes University Hospital
Collaborating Sponsors:
Regeneron Pharmaceuticals
Conditions:
Type2 Diabetes
Eligibility:
MALE
18-75 years
Phase:
PHASE3
Brief 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...
Detailed Description
Recently, human monoclonal antibodies directed against PCSK9 have been shown to be effective in reducing LDL cholesterol. Besides the liver, little is known about the role of PCSK9 in the small intest...
Eligibility Criteria
Inclusion
- 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
- 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 than statins), including fibrates, omega-3 fatty acids, bile acid sequestrants, niacin.
- Insulin-treated patients
- History of bariatric surgery
- Inflammatory bowel diseases and gastrointestinal malabsorption diseases
- Uncontrolled hypothyroidism (TSH \> ULN and Free T4 \< ULN) or hyperthyroidism (TSH \< ULN)
- Active cancer: progressive cancer or remission ≤ 3 years, except for basal or squamous cell carcinoma of the skin that has been successfully treated
- Known history of positive test for HIV, hepatitis C or chronic hepatitis B
- Corticosteroids therapy
- Minors
- Adults under guardianship or trusteeship
Key Trial Info
Start Date :
February 12 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 28 2022
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT03344692
Start Date
February 12 2019
End Date
April 28 2022
Last Update
September 27 2022
Active Locations (1)
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1
University Hospital of Nantes
Nantes, France, 44093