diabetes mellitus type 2 MedDRA version: 9.1 Level: LLT Classification code 10012601 Term: Diabetes mellitus
Conditions
Interventions
Product Name: simvastatine
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: simvastatine
CAS Number: 79902-63-9
Concentration unit: g gram(s)
Concentration type: equal
Concentration number
Sponsors
LUMC
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: diabetes mellitus type 2 treated with metformin alone or in combination with SU-derivate HbA1c20 kg/m2 and =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: use of insulin or thiazolidinediones use of fibrates or statins one year prior to the study hereditary lipoprotein disease renal disease: creatinine clearance100 micromol/l allergy to intravenous contrast metal implants, claustrophobia or other contraindications for MRI any significant chronic disease, hepatic disease or other endocrine disease pregnancy/lactation psychiatric disorders and/or use of antipsychotic or antidepressant drugs recent participation in other research projects in the last 3 months or participation in 2 or more projects in one year
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To study the effect of simvastatin on myocardial triglyceride accumulation and cardiac function in diabetes mellitus type 2 using MRI and MR spectroscopy;Secondary Objective: To study the effect of simvastatin on: - total vessel wall area and thickness - liver triglyceride content ;Primary end point(s): Difference in the following end-points after placebo or simvastatine in: myocardial triglyceride content heart dimensions systoloic and diastolic heart function | — |
Countries
Netherlands
Outcome results
None listed