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Effects of ezetimibe in association with statins on postprandial lipemia in type 2 diabetic patients - Ezetimibe effects on postprandial lipemia

Effects of ezetimibe in association with statins on postprandial lipemia in type 2 diabetic patients - Ezetimibe effects on postprandial lipemia

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2008-000824-20-IT
Enrollment
Unknown
Registered
2009-05-25
Start date
2008-06-15
Completion date
Unknown
Last updated
2012-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 diabetes mellitus MedDRA version: 9.1 Level: SOC Classification code 10027433 MedDRA version: 9.1 Level: HLGT Classification code 10013317 MedDRA version: 9.1 Level: PT Classification code 10062060 MedDRA version: 9.1 Level: LLT Classification code 10020661

Interventions

Pharmaceutical Form: Tablet INN or Proposed INN: Simvastatin and ezetimibe Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 10- Pharmaceutical Form: Tablet INN or P

Sponsors

UNIVERSITA` DEGLI STUDI DI NAPOLI FEDERICO II
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: - Type 2 diabetes since at least two years - Stable metabolic control (HbA1c130 mg/dl, plasma triglycerides =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - Patient with renal (serum creatinine >1.5 mg/dl) or hepatic (serum transaminases >three times upper normal values) impairment. - Patients with history of cardiovascular disease. - Pre-menopausal women. - Any other acute or chronic degenerative disease. - Anemia (Hb<12 g/dl). - Uncontrolled blood pressure. - Use of any drugs able to interfere with the study medications.

Design outcomes

Primary

MeasureTime frame
Main Objective: The aims of this protocol are to evaluate the effects of ezetimibe - in association with a statin vs. a statin alone - on postprandial lipemia, in particular on the number and composition of either intestinally derived and hepatic derived lipoprotein particles, in type 2 diabetic patients.;Secondary Objective: to evaluate the effects of ezetimibe - in association with a statin vs. a statin alone - on: - Fasting LDL cholesterol concentration. - Cholesterol/triglyceride ratio in postprandial chylomicrons and VLDL fractions. - Postprandial LDL size. - Concentration and Composition of different lipoprotein subclasses in the fasting condition.;Primary end point(s): Incremental AUC after a fat-rich meal of cholesterol concentration in chylomicron and VLDL fractions.—

Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026