Cardiovascular Disease, Diabetes Mellitus, Type 2, Kidney Disease
Conditions
Keywords
Microalbuminuria
Brief summary
This is a study in diabetic patients with at least one additional cardiovascular risk factor and normoalbuminuria prior to randomization.
Interventions
DRUGOlmesartan medoxomil
tablets
DRUGPlacebo Tablets
Tablets
Sponsors
Sankyo Pharma Gmbh
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Diabetes mellitus type 2, defined as fasting blood glucose of greater than or equal to 126 mg/dL; * Presence of at least one of the following cardiovascular risk factors: 1. total cholesterol greater than 200 mg/dL or statin treatment, 2. High density lipoprotein (HDL) less than 40 mg/dL, 3. triglycerides greater than 150 mg/dL and less than 400 mg/dL, 4. blood pressure greater than or equal to 130/80 mmHg, 5. Body mass index (BMI) greater than 28 kg/m2, 6. waist circumference greater than 102 cm for men and greater than 88 cm for women, 7. smoking of more than 5 cigarettes a day; * Normoalbuminuria at screening
Exclusion criteria
* Severe uncontrolled hyperlipidemia; * Documented renal and/or renal-vascular disease; * Myocardial infarction, stroke or myocardial revascularization within the last 6 months; * History of alcohol and/or drug abuse; * Allergic reaction, lack of response or contraindication to angiotensin receptor blockers (ARBs); * Current treatment with an ARB or angiotensin converting enzyme (ACE) inhibitor
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to the first occurrence of microalbuminuria defined as excretion of greater than 35 mg albumin/g urine creatinine for women and greater than 25 mg albumin/g urine creatinine for men in morning spot urine | Time to the first occurrence |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of cardiovascular mortality and morbidity | Time to occurence |
| Incidence of renal disease, such as worsening of renal function as well as end-stage (dialysis) | Time to occurrence |
| Occurrence and progression of retinopathy | Time to occurence |
| Treatment effects on a combined endpoint of cardiovascular mortality and morbidity and renal disease | Time to occurrence |
| Safety and tolerability | Throughout entire study |
Countries
Germany
Outcome results
None listed