Phase 4
N=36
Vascular Effects of Carvedilol Versus Metoprolol in Hypertensive Patients With Type 2 Diabetes
Hypertension · Type 2 Diabetes Mellitus
Bottom Line
View on ClinicalTrials.gov: NCT00123604 ↗Enrolled (actual)
36
Serious AEs
0.0%
Results posted
Nov 2014
Primary outcome: Primary: Flow Mediated Dilation — 6.2; 4.1 percentage of change in dilation
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Carvedilol (Drug); Metoprolol (Drug)
- Age
- Adult, Older Adult · 30+ yrs
- Sex
- All
- Sponsor
- St. Paul Heart Clinic
- Primary completion
- Jun 2006
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Flow Mediated Dilation |
6.2; 4.1 | — |
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.
Eligibility 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 ( 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
Data sourced from ClinicalTrials.gov (NCT00123604). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.