Olmesartan Medoxomil in Diabetes Mellitus

Daiichi Sankyo

Status and phase

Completed

Phase 3

Conditions

Diabetes Mellitus, Type 2

Kidney Disease

Cardiovascular Disease

Treatments

Drug: Olmesartan medoxomil

Drug: Placebo Tablets

Study type

Interventional

Funder types

Industry

Identifiers

SE-866/44

Details and patient eligibility

About

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

Enrollment

4,449 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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