Vascular Effects of Carvedilol Versus Metoprolol in Hypertensive Patients With Type 2 Diabetes

• Status: Completed
• Trial end date: 2006-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to compare the vascular effects of two commonly used blood pressure medications, carvedilol and metoprolol in hypertensive patients with type 2 diabetes.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: St. Paul Heart Clinic
• Collaborator: GlaxoSmithKline
• Treatments: Carvedilol; Metoprolol

Criteria

Inclusion Criteria:

• Age 30-80 years old

• Documented history of type 2 diabetes

• Stable angiotensin converting enzyme/angiotensin receptor blocker (ACE/ARB) regimen 30 days before and throughout the study period

• Stable anti-diabetic regimen throughout the study period

• Body mass index (BMI) between 22-45 kg/m2

• HbA1c between 6-9% for patients on anti-diabetic treatment regimen and HbA1c between 6-8% for patients who are being controlled by diet alone

• Screening blood pressure (BP) > 130/80 (average of 3 sitting measurements), with current medications

Exclusion Criteria:

• Uncontrollable or symptomatic arrhythmias

• Unstable angina

• Sick sinus syndrome or second or third degree heart block

• Decompensated heart failure

• Myocardial infarction (MI) or stroke within 3 months of screening

• Bradycardia

• Chronic obstructive pulmonary disease (COPD) with required inhaled or oral bronchodilators or corticosteroids

• Bronchial asthma or related bronchospastic conditions

• New onset/diagnosed type 2 diabetes (<3 months)

• Clinically significant renal or liver disease (creatinine >2.5 mg/dL)

• Endocrine disorders

• Use of anorectic or other diet drugs inconsistent with recommendations for type 2 diabetics

• Use of beta-blockers within 3 months of screening

• Use of corticosteroids

• Systemic disease, including cancer, with reduced life expectancy (<12 months)

• Psychological illness/condition that interferes with comprehension of study requirements

• Use of an investigational drug within 30 days of entry into study