Olmesartan Medoxomil in Diabetes Mellitus

Phase 3

Completed

• Conditions: Diabetes Mellitus, Type 2; Cardiovascular Disease; Kidney Disease
• Interventions: Drug: Placebo Tablets; Drug: Olmesartan medoxomil

• Registration Number: NCT00185159
• Lead Sponsor: Sankyo Pharma Gmbh

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2004-10
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-16
• Primary Completion: 2009-07
• Study Completion: 2009-07
• Status Verified: 2010-01
• Last Update Submitted: 2010-01-19
• Last Update Posted: 2010-01-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4449

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Placebo Tablets	placebo
1	Olmesartan medoxomil	olmesartan medoxomil

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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