Olmesartan Medoxomil in Diabetes Mellitus

Sankyo Pharma Gmbh4,449 enrolled

Overview

This is a study in diabetic patients with at least one additional cardiovascular risk factor and normoalbuminuria prior to randomization.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

4,449

Conditions

Diabetes Mellitus, Type 2 Cardiovascular Disease Kidney Disease

Interventions

Olmesartan medoxomilDRUG

tablets

Placebo TabletsDRUG

Tablets

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Unnamed facility

Darmstadt, Germany

Outcomes

Primary Outcomes

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 frame: Time to the first occurrence

Secondary Outcomes

Incidence of cardiovascular mortality and morbidity

Time frame: Time to occurence

Incidence of renal disease, such as worsening of renal function as well as end-stage (dialysis)

Time frame: Time to occurrence

Occurrence and progression of retinopathy

Time frame: Time to occurence

Treatment effects on a combined endpoint of cardiovascular mortality and morbidity and renal disease

Time frame: Time to occurrence

Safety and tolerability

Time frame: Throughout entire study

Data from ClinicalTrials.gov

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