NCT01384058

Effect of Ezetimibe or Simvastatin or Both on Low Densitiy Lipoprotein -Subfractions in Patients With Type 2 Diabetes

The Effect of Ezetimibe 10 mg, Simvastatin 20 mg and the Combination of Simvastatin 20 mg Plus 10 mg Ezetimibe on Low Density Lipoprotein (LDL)-Subfractions in Patients With Type 2 Diabetes

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: University Hospital Freiburg · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

It is of interest how ezetimibe alone or in combination with statin may influence atherogenic dense Low Density Lipoprotein (dLDL) in patients with type 2 diabetes mellitus. The primary objective of this study will be whether there is a change of the concentrations of Apolipoprotein B (ApoB) in dLDL from baseline in each of the 3 treatment groups.

Detailed description

The selective cholesterol resorption inhibitor ezetimibe belongs to a new class of cholesterol lowering drugs. It is of interest how ezetimibe alone or in combination with statin may influence atherogenic dense Low Density Lipoprotein (dLDL) in patients with type 2 diabetes mellitus. The primary objective of this study will be whether there is a change of the concentrations of Apolipoprotein B (ApoB) in dLDL from baseline in each of the 3 treatment groups. The comparison between treatment groups is exploratory due to insufficient power to detect any change between treatments.

Conditions

• Diabetes Mellitus Type 2
• Hypercholesterolemia

Interventions

Type	Name	Description
DRUG	ezetimibe	ezetimibe 10 mg per day for six weeks
DRUG	simvastatin	Simvastatin 20 mg per day for six weeks
DRUG	Ezetimibe 10/Simvastatin 20	Ezetimibe 10mg/Simvastatin 20mg per day for six weeks

Timeline

• Start date: 2007-11-01
• Primary completion: 2010-05-01
• Completion: 2010-06-01
• First posted: 2011-06-28
• Last updated: 2012-06-19

Locations

2 sites across 1 country: Germany