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

NCT ID: NCT00123604

Last Updated: 2014-11-18

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-06-30

Study Completion Date

2006-06-30

Brief Summary

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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.

Detailed Description

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Carvedilol and metoprolol are two commonly used blood pressure medications that have both been shown to be effective in controlling hypertension. Although in the same drug class, preliminary data have shown that these medications may have different vascular effects. This study will assess which medication is better at improving artery health independent of their blood pressure lowering effects. Artery health will be assessed non-invasively by ultrasound. Certain markers of atherosclerosis found in the blood will also be measured.

Conditions

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Hypertension Type 2 Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Carvedilol

Carvedilol, orally, 25 mg, twice daily for five months

Group Type EXPERIMENTAL

Carvedilol

Intervention Type DRUG

25 mg twice daily for five months.

Metoprolol

Metoprolol, orally, 200 mg, twice daily for five months.

Group Type ACTIVE_COMPARATOR

Metoprolol

Intervention Type DRUG

200 mg twice daily for five months.

Interventions

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Carvedilol

25 mg twice daily for five months.

Intervention Type DRUG

Metoprolol

200 mg twice daily for five months.

Intervention Type DRUG

Other Intervention Names

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Coreg Lopressor

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role collaborator

St. Paul Heart Clinic

OTHER

Sponsor Role lead

Responsible Party

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Aaron S. Kelly, Ph.D.

Senior Research Scientist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Alan J Bank, M.D.

Role: PRINCIPAL_INVESTIGATOR

St. Paul Heart Clinic

Locations

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St. Paul Heart Clinic

Saint Paul, Minnesota, United States

Site Status

Countries

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United States

References

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Bank AJ, Kelly AS, Thelen AM, Kaiser DR, Gonzalez-Campoy JM. Effects of carvedilol versus metoprolol on endothelial function and oxidative stress in patients with type 2 diabetes mellitus. Am J Hypertens. 2007 Jul;20(7):777-83. doi: 10.1016/j.amjhyper.2007.01.019.

Reference Type DERIVED
PMID: 17586413 (View on PubMed)

Other Identifiers

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GSK101598

Identifier Type: -

Identifier Source: org_study_id