Olmesartan Medoxomil in Diabetes Mellitus

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

Official Title
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Randomized Olmesartan and Diabetes Microalbuminuria Prevention Study (ROADMAP)

Conditions
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Diabetes Mellitus, Type 2, Cardiovascular Disease, Kidney Disease

Intervention / Treatment
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* Drug: Olmesartan medoxomil
* Drug: Placebo Tablets


Participation Criteria
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Eligibility Criteria
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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: total cholesterol greater than 200 mg/dL or statin treatment, High density lipoprotein (HDL) less than 40 mg/dL, triglycerides greater than 150 mg/dL and less than 400 mg/dL, blood pressure greater than or equal to 130/80 mmHg, Body mass index (BMI) greater than 28 kg/m2, waist circumference greater than 102 cm for men and greater than 88 cm for women, 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>olmesartan medoxomil | Drug: Olmesartan medoxomil<br>* tablets<br>|
| Placebo Comparator: 2<br>placebo | Drug: Placebo Tablets<br>* Tablets<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Microalbuminuria