Glycemic Control Of Carvedilol Versus Metoprolol In Patients With Type II Diabetes Mellitus And Hypertension

April 14, 2015 updated by: GlaxoSmithKline

A Randomized, Double-Blind, Multicenter Study Comparing the Glycemic Control Characteristics of Carvedilol and Metoprolol in Hypertensive Patients With Type II Diabetes Mellitus.

To evaluate the effects of two different antihypertensive medications in the drug class of beta-blockers on control of glucose in Type II diabetic patients with high blood pressure.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

1210

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Glendale, Arizona, United States, 85306
        • GSK Investigational Site
      • Phoenix, Arizona, United States, 85050
        • GSK Investigational Site
      • Phoenix, Arizona, United States, 85016
        • GSK Investigational Site
      • Tucson, Arizona, United States, 85724
        • GSK Investigational Site
    • California
      • Burlingame, California, United States, 94010
        • GSK Investigational Site
      • Concord, California, United States, 94520
        • GSK Investigational Site
      • Encinitas, California, United States, 92024
        • GSK Investigational Site
      • Hemet, California, United States, 92543
        • GSK Investigational Site
      • Long Beach, California, United States, 90806
        • GSK Investigational Site
      • Orange, California, United States, 92868
        • GSK Investigational Site
      • Pasadena, California, United States, 91105
        • GSK Investigational Site
      • Riverside, California, United States, 92501
        • GSK Investigational Site
      • San Diego, California, United States, 92102
        • GSK Investigational Site
      • San Luis Obispo, California, United States, 93405
        • GSK Investigational Site
      • Spring Valley, California, United States, 91978
        • GSK Investigational Site
    • Colorado
      • Aurora, Colorado, United States, 80045
        • GSK Investigational Site
      • Denver, Colorado, United States, 80220
        • GSK Investigational Site
      • Golden, Colorado, United States, 80401
        • GSK Investigational Site
    • Florida
      • Panama City, Florida, United States, 32401
        • GSK Investigational Site
      • St. Petersburg, Florida, United States, 33701
        • GSK Investigational Site
    • Hawaii
      • Honolulu, Hawaii, United States, 96813
        • GSK Investigational Site
    • Idaho
      • Idaho Falls, Idaho, United States, 83404
        • GSK Investigational Site
    • Illinois
      • Chicago, Illinois, United States, 60612
        • GSK Investigational Site
      • O'Fallon, Illinois, United States, 62269
        • GSK Investigational Site
    • Indiana
      • Elkhart, Indiana, United States, 46515
        • GSK Investigational Site
      • Indianapolis, Indiana, United States, 46260
        • GSK Investigational Site
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • GSK Investigational Site
    • Michigan
      • Kalamazoo, Michigan, United States, 49009
        • GSK Investigational Site
      • Oak Park, Michigan, United States, 48237
        • GSK Investigational Site
    • Minnesota
      • Minneapolis, Minnesota, United States, 55417
        • GSK Investigational Site
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • GSK Investigational Site
      • Kansas City, Missouri, United States, 64106
        • GSK Investigational Site
      • St. Louis, Missouri, United States, 63110
        • GSK Investigational Site
      • St. Louis, Missouri, United States, 63128
        • GSK Investigational Site
    • Nevada
      • Las Vegas, Nevada, United States, 89103
        • GSK Investigational Site
    • New Mexico
      • Albuquerque, New Mexico, United States, 87131
        • GSK Investigational Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
        • GSK Investigational Site
    • Oregon
      • Bend, Oregon, United States, 97701
        • GSK Investigational Site
      • Oregon City, Oregon, United States, 97045
        • GSK Investigational Site
    • Texas
      • Dallas, Texas, United States, 75390
        • GSK Investigational Site
      • Fort Worth, Texas, United States, 76104
        • GSK Investigational Site
      • Georgetown, Texas, United States, 78626
        • GSK Investigational Site
      • Midland, Texas, United States, 79705
        • GSK Investigational Site
      • San Antonio, Texas, United States, 78299
        • GSK Investigational Site
      • San Antonio, Texas, United States, 78259
        • GSK Investigational Site
      • The Colony, Texas, United States, 75056
        • GSK Investigational Site
    • Utah
      • Ogden, Utah, United States, 84401
        • GSK Investigational Site
    • Washington
      • Renton, Washington, United States, 98055
        • GSK Investigational Site
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • GSK Investigational Site
      • Milwaukee, Wisconsin, United States, 53151
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria:

  • Patients at screening must be insulin producing Type II diabetics (C peptide positive).
  • Must have a history of mild to moderate hypertension (140-179 systolic; 90-1-9 diastolic).
  • Must be on stable regimen of ACE (angiotensin converting enzyme) / ARB (angiotensin receptor blocker) treatment alone or in combination with other treatments.
  • Patient''s laboratory result for HbA1c must be 6.5 - 8.5 (drug treated) or 6.5 - 7.5 (diet alone).
  • Must be on a stable antidiabetic regimen (drug treated or diet alone).

Exclusion criteria:

  • Patients using beta-blocker therapy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in HbA1c at 5 months
Time Frame: 5 months
5 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Blood pressure at 3 and 5 months. Body weight at 3 and 5 months. Lab values (glucose, insulin, triglycerides, cholesterol, and albumin:creatinine ratio) at 3 and 5 months.
Time Frame: 5 months
5 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2001

Primary Completion (Actual)

April 1, 2004

Study Completion (Actual)

April 1, 2004

Study Registration Dates

First Submitted

May 15, 2003

First Submitted That Met QC Criteria

May 15, 2003

First Posted (Estimate)

May 16, 2003

Study Record Updates

Last Update Posted (Estimate)

April 15, 2015

Last Update Submitted That Met QC Criteria

April 14, 2015

Last Verified

June 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 105517/346

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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