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Phase 4 Completed N=36 Randomized Quadruple-blind Prevention

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

Source: ClinicalTrials.gov NCT00123604 ↗
Enrolled (actual)
36
Serious AEs
0.0%
Results posted
Nov 2014
Primary outcomePrimary: Flow Mediated Dilation — 6.2; 4.1 percentage of change in dilation

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.

Outcome Measures

OutcomeResultp-value
PRIMARY
Flow Mediated Dilation
6.2; 4.1

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
View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.

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