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Clinical Trial Details

Trial ID: L2617
Source ID: NCT03344692
Associated Drug: Alirocumab
Title: Effect of Alirocumab on Postprandial Hyperlipemia in Patients With Type 2 Diabetes
Acronym: EUTERPE
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type2 Diabetes
Interventions: DRUG: Alirocumab|OTHER: Placebo
Outcome Measures: Primary: Total area under the post-prandial triglycerides concentration-time curve from meal-time until 8h (AUC0-8h) after standardized high fat meal., Fifteenth days after the fifth injection of treatment (thus 10 weeks after first injection of treatment), subjects will be reported to investigational site (after a 12 hours overnight fast). Subjects must consume the test meal within 15 min. Upon completion of the meal (T0), sequential postprandial measurements of triglycerides concentrations will be taken. Blood samples will be collected at T-15, every 30 min for the first two hours after meal consumption, thereafter in 60 min intervals from T120 until 240 min and thereafter in 120 min intervals from T240 until 480 min., During 8 hours at week 10 after first treatment injection | Secondary: Effect of treatment with alirocumab versus placebo following a standardized high-fat meal on post-prandial lipid metabolism (plasma lipoproteins, apolipoproteins, ...), Fifteenth days after the fifth injection of treatment (thus 10 weeks after first injection of treatment), subjects will be reported to investigational site (after a 12 hours overnight fast). Subjects must consume the test meal within 15 min. Upon completion of the meal (T0), sequential postprandial measurements of triglycerides concentrations will be taken. Bleed samples will be collected at T-15, every 30 min for the first two hours after meal consumption, thereafter in 60 min intervals from T120 until 240 min and thereafter in 120 min intervals from T240 until 480 min., During 8 hours at week 10 after first treatment injection|Effect of treatment with alirocumab versus placebo on fasting lipid metabolism following a standardized high fat meal, using the same biomarkers than those used in the post-prandial state, plus indirect markers of cholesterol absorption and synthesis, Fifteenth days after the fifth injection of treatment (thus 10 weeks after first injection of treatment), subjects will be reported to investigational site after a 12 hours overnight fast. Before ingestion of the high fat meal, blood sample will be removed to perform the analysis., 10 weeks after treatment first injection|Effect of treatment with alirocumab versus placebo on fasting and post-prandial and glucose homeostasis following a standardized high-fat meal, Fasting self-monitored blood glucose test will be obtained before starting the meal and every hour during 8 hours ., Before and during 8 hours after high fat meal at week 10 after first treatment injection
Sponsor/Collaborators: Sponsor: Nantes University Hospital | Collaborators: Regeneron Pharmaceuticals
Gender: MALE
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 22
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2019-02-12
Completion Date: 2022-04-28
Results First Posted:
Last Update Posted: 2022-09-27
Locations: University Hospital of Nantes, Nantes, 44093, France
URL: https://clinicaltrials.gov/show/NCT03344692