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

April 13, 2015 updated by: GlaxoSmithKline

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

Evaluation of the effect of two different antihypertensive treatments on control of glucose in Type II diabetic patients with high blood pressure

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

501

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
    • Alabama
      • Birmingham, Alabama, United States, 35211
        • GSK Investigational Site
      • Birmingham, Alabama, United States, 35294-0012
        • GSK Investigational Site
      • Birmingham, Alabama, United States, 35294-2041
        • GSK Investigational Site
      • Columbia, Alabama, United States, 35051
        • GSK Investigational Site
      • Mobile, Alabama, United States, 36608
        • GSK Investigational Site
    • Connecticut
      • Derby, Connecticut, United States, 06418
        • GSK Investigational Site
      • Farmington, Connecticut, United States, 06030 - 1410
        • GSK Investigational Site
      • Hartford, Connecticut, United States, 06106
        • GSK Investigational Site
      • New Britain, Connecticut, United States, 06050
        • GSK Investigational Site
    • Delaware
      • Newark, Delaware, United States, 19713
        • GSK Investigational Site
    • District of Columbia
      • Washington, District of Columbia, United States, 20037
        • GSK Investigational Site
      • Washington, District of Columbia, United States, 20422
        • GSK Investigational Site
    • Florida
      • Coral Gables, Florida, United States, 33134
        • GSK Investigational Site
      • Fort Lauderdale, Florida, United States, 33316
        • GSK Investigational Site
      • Fort Lauderdale, Florida, United States, 33308
        • GSK Investigational Site
      • Fort Meyers, Florida, United States, 33907
        • GSK Investigational Site
      • Gainesville, Florida, United States, 32605
        • GSK Investigational Site
      • Hollywood, Florida, United States, 33021
        • GSK Investigational Site
      • Hollywood, Florida, United States, 33023
        • GSK Investigational Site
      • Inverness, Florida, United States, 34452
        • GSK Investigational Site
      • Jacksonville, Florida, United States, 32216
        • GSK Investigational Site
      • Jacksonville, Florida, United States, 32205
        • GSK Investigational Site
      • Melbourne, Florida, United States, 32901
        • GSK Investigational Site
      • Miami, Florida, United States, 33136
        • GSK Investigational Site
      • Miami, Florida, United States, 33156
        • GSK Investigational Site
      • Miami, Florida, United States, 33176
        • GSK Investigational Site
      • Miami, Florida, United States, 33133
        • GSK Investigational Site
      • Ocala, Florida, United States, 34471
        • GSK Investigational Site
      • Ocala, Florida, United States, 34474
        • GSK Investigational Site
      • Pembroke Pines, Florida, United States, 33024
        • GSK Investigational Site
      • Saint Petersberg, Florida, United States, 33705
        • GSK Investigational Site
      • Sarasota, Florida, United States, 34239
        • GSK Investigational Site
      • Tamarac, Florida, United States, 33321
        • GSK Investigational Site
      • Tampa, Florida, United States, 33614
        • GSK Investigational Site
    • Georgia
      • Augusta, Georgia, United States, 30901
        • GSK Investigational Site
      • Fayetteville, Georgia, United States, 30214
        • GSK Investigational Site
      • Lawrenceville, Georgia, United States, 30045
        • GSK Investigational Site
      • Savannah, Georgia, United States, 31406
        • GSK Investigational Site
    • Illinois
      • Chicago, Illinois, United States, 60616
        • GSK Investigational Site
      • West Evanston, Illinois, United States, 60202
        • GSK Investigational Site
    • Indiana
      • Newburgh, Indiana, United States, 47630
        • GSK Investigational Site
      • Wabash, Indiana, United States, 46992
        • GSK Investigational Site
    • Kentucky
      • Lexington, Kentucky, United States, 40508
        • GSK Investigational Site
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • GSK Investigational Site
      • New Orleans, Louisiana, United States, 70121
        • GSK Investigational Site
    • Maine
      • Auburn, Maine, United States, 04210
        • GSK Investigational Site
      • Bangor, Maine, United States, 04401
        • GSK Investigational Site
    • Maryland
      • Baltimore, Maryland, United States, 21208
        • GSK Investigational Site
      • Baltimore, Maryland, United States, 21204
        • GSK Investigational Site
    • Massachusetts
      • Ayer, Massachusetts, United States, 01432
        • GSK Investigational Site
      • Boston, Massachusetts, United States, 02115
        • GSK Investigational Site
      • Haverhill, Massachusetts, United States, 01831-2451
        • GSK Investigational Site
      • Springfield, Massachusetts, United States, 01107
        • GSK Investigational Site
      • Waltham, Massachusetts, United States, 02453
        • GSK Investigational Site
      • Worcester, Massachusetts, United States, 01605
        • GSK Investigational Site
      • Worcester, Massachusetts, United States, 01610
        • GSK Investigational Site
    • Michigan
      • Waterford, Michigan, United States, 48328
        • GSK Investigational Site
    • Mississippi
      • Gulfport, Mississippi, United States, 39501
        • GSK Investigational Site
    • New Jersey
      • Camden, New Jersey, United States, 08103
        • GSK Investigational Site
      • Hackensack, New Jersey, United States, 07601
        • GSK Investigational Site
      • Linwood, New Jersey, United States, 08221
        • GSK Investigational Site
      • Margate, New Jersey, United States, 08402
        • GSK Investigational Site
      • Sea Girt, New Jersey, United States, 08750
        • GSK Investigational Site
      • Voorhees, New Jersey, United States, 08043
        • GSK Investigational Site
    • New York
      • Bronx, New York, United States, 10461
        • GSK Investigational Site
      • Bronx, New York, United States, 10467
        • GSK Investigational Site
      • Buffalo, New York, United States, 14209
        • GSK Investigational Site
      • Flushing, New York, United States, 11365
        • GSK Investigational Site
      • Fulton, New York, United States, 13069
        • GSK Investigational Site
      • Kingston, New York, United States, 12401
        • GSK Investigational Site
      • Lancaster, New York, United States, 14043
        • GSK Investigational Site
      • Liverpool, New York, United States, 13088
        • GSK Investigational Site
      • New Hyde Park, New York, United States, 11040
        • GSK Investigational Site
      • New York, New York, United States, 10032
        • GSK Investigational Site
      • New York, New York, United States, 10021
        • GSK Investigational Site
      • New York, New York, United States, 10028
        • GSK Investigational Site
      • Rochester, New York, United States, 14609
        • GSK Investigational Site
      • Scarsdale, New York, United States, 10583
        • GSK Investigational Site
      • Syracuse, New York, United States, 13202
        • GSK Investigational Site
      • Tonawanda, New York, United States, 14150
        • GSK Investigational Site
      • Williamsville, New York, United States, 14221
        • GSK Investigational Site
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • GSK Investigational Site
      • Hickory, North Carolina, United States, 28601
        • GSK Investigational Site
      • Raleigh, North Carolina, United States, 27609
        • GSK Investigational Site
      • Statesville, North Carolina, United States, 28677
        • GSK Investigational Site
      • Wilmington, North Carolina, United States, 28412
        • GSK Investigational Site
      • Winston-Salem, North Carolina, United States, 27103
        • GSK Investigational Site
    • Ohio
      • Canton, Ohio, United States, 44708
        • GSK Investigational Site
      • Cincinnati, Ohio, United States, 45246
        • GSK Investigational Site
      • Cleveland, Ohio, United States, 44106
        • GSK Investigational Site
      • Columbus, Ohio, United States, 43212
        • GSK Investigational Site
      • Zanesville, Ohio, United States, 43701
        • GSK Investigational Site
    • Pennsylvania
      • Camp Hill, Pennsylvania, United States, 17011
        • GSK Investigational Site
      • Connellsville, Pennsylvania, United States, 15425
        • GSK Investigational Site
      • Downington, Pennsylvania, United States, 19335
        • GSK Investigational Site
      • Erie, Pennsylvania, United States, 16505
        • GSK Investigational Site
      • Fleetwood, Pennsylvania, United States, 19522
        • GSK Investigational Site
      • Morrisville, Pennsylvania, United States, 19067
        • GSK Investigational Site
      • Philadelphia, Pennsylvania, United States, 19107
        • GSK Investigational Site
      • Philadelphia, Pennsylvania, United States, 19104
        • GSK Investigational Site
      • Philipsburgh, Pennsylvania, United States, 16966
        • GSK Investigational Site
      • Pittsburgh, Pennsylvania, United States, 15241
        • GSK Investigational Site
      • Pittsburgh, Pennsylvania, United States, 15206
        • GSK Investigational Site
      • West Grove, Pennsylvania, United States, 19390
        • GSK Investigational Site
    • South Carolina
      • Columbia, South Carolina, United States, 29201
        • GSK Investigational Site
      • Greer, South Carolina, United States, 29651
        • GSK Investigational Site
      • Summerville, South Carolina, United States, 29485
        • GSK Investigational Site
    • Tennessee
      • Bristol, Tennessee, United States, 37620
        • GSK Investigational Site
      • Jackson, Tennessee, United States, 38301
        • GSK Investigational Site
      • Memphis, Tennessee, United States, 38163
        • GSK Investigational Site
      • Nashville, Tennessee, United States, 37212
        • GSK Investigational Site
    • Utah
      • White River Junction, Utah, United States, 05009
        • GSK Investigational Site
    • Virginia
      • Christiansburg, Virginia, United States, 24073
        • GSK Investigational Site
      • Falls Church, Virginia, United States, 22044
        • GSK Investigational Site
      • Fredericksburg, Virginia, United States, 20401
        • GSK Investigational Site
      • Richmond, Virginia, United States, 23294
        • GSK Investigational Site
      • Richmond, Virginia, United States, 23220
        • GSK Investigational Site
      • Salem, Virginia, United States, 24153
        • GSK Investigational Site
      • Springfield, Virginia, United States, 22151
        • 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

26 years to 76 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).
  • Patients must have a history of mild to moderate hypertension (140-179 systolic blood pressure; 90-1-9 diastolic blood pressure)
  • Patients must be on a stable regimen of ACE (angiotensin converting enzyme) / ARB (angiotensin receptor blocker) treatment alone or in combination with other treatments.
  • Patients must be on stable antidiabetic regimen (drug treated or diet alone).
  • Patient''s laboratory result for HbA1c must be 6.5 - 8.5 (drug treated) or 6.5 - 7.5 (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 levels (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 14, 2015

Last Update Submitted That Met QC Criteria

April 13, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 105517/347

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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