Effect Of Carvedilol Versus Metoprolol On Glycemic Control In Patients With Type II Diabetes And Hypertension
A Randomized, Double-Blind, Multicenter Study Comparing the Effects of Carvedilol and Metoprolol on Glycemic Control in Hypertensive Patients With Type II Diabetes Mellitus.
1 other identifier
interventional
501
1 country
119
Brief Summary
Evaluation of the effect of two different antihypertensive treatments on control of glucose in Type II diabetic patients with high blood pressure
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 hypertension
Started Jun 2001
Typical duration for phase_4 hypertension
119 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2001
CompletedFirst Submitted
Initial submission to the registry
May 15, 2003
CompletedFirst Posted
Study publicly available on registry
May 16, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2004
CompletedApril 14, 2015
April 1, 2015
2.8 years
May 15, 2003
April 13, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from baseline in HbA1c at 5 months
5 months
Secondary Outcomes (1)
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.
5 months
Interventions
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- Patients using beta-blocker therapy.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (119)
GSK Investigational Site
Birmingham, Alabama, 35211, United States
GSK Investigational Site
Birmingham, Alabama, 35294-0012, United States
GSK Investigational Site
Birmingham, Alabama, 35294-2041, United States
GSK Investigational Site
Columbia, Alabama, 35051, United States
GSK Investigational Site
Mobile, Alabama, 36608, United States
GSK Investigational Site
Derby, Connecticut, 06418, United States
GSK Investigational Site
Farmington, Connecticut, 06030 - 1410, United States
GSK Investigational Site
Hartford, Connecticut, 06106, United States
GSK Investigational Site
New Britain, Connecticut, 06050, United States
GSK Investigational Site
Newark, Delaware, 19713, United States
GSK Investigational Site
Washington D.C., District of Columbia, 20037, United States
GSK Investigational Site
Washington D.C., District of Columbia, 20422, United States
GSK Investigational Site
Coral Gables, Florida, 33134, United States
GSK Investigational Site
Fort Lauderdale, Florida, 33308, United States
GSK Investigational Site
Fort Lauderdale, Florida, 33316, United States
GSK Investigational Site
Fort Meyers, Florida, 33907, United States
GSK Investigational Site
Gainesville, Florida, 32605, United States
GSK Investigational Site
Hollywood, Florida, 33021, United States
GSK Investigational Site
Hollywood, Florida, 33023, United States
GSK Investigational Site
Inverness, Florida, 34452, United States
GSK Investigational Site
Jacksonville, Florida, 32205, United States
GSK Investigational Site
Jacksonville, Florida, 32216, United States
GSK Investigational Site
Melbourne, Florida, 32901, United States
GSK Investigational Site
Miami, Florida, 33133, United States
GSK Investigational Site
Miami, Florida, 33136, United States
GSK Investigational Site
Miami, Florida, 33156, United States
GSK Investigational Site
Miami, Florida, 33176, United States
GSK Investigational Site
Ocala, Florida, 34471, United States
GSK Investigational Site
Ocala, Florida, 34474, United States
GSK Investigational Site
Pembroke Pines, Florida, 33024, United States
GSK Investigational Site
Saint Petersberg, Florida, 33705, United States
GSK Investigational Site
Sarasota, Florida, 34239, United States
GSK Investigational Site
Tamarac, Florida, 33321, United States
GSK Investigational Site
Tampa, Florida, 33614, United States
GSK Investigational Site
Augusta, Georgia, 30901, United States
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Fayetteville, Georgia, 30214, United States
GSK Investigational Site
Lawrenceville, Georgia, 30045, United States
GSK Investigational Site
Savannah, Georgia, 31406, United States
GSK Investigational Site
Chicago, Illinois, 60616, United States
GSK Investigational Site
West Evanston, Illinois, 60202, United States
GSK Investigational Site
Newburgh, Indiana, 47630, United States
GSK Investigational Site
Wabash, Indiana, 46992, United States
GSK Investigational Site
Lexington, Kentucky, 40508, United States
GSK Investigational Site
New Orleans, Louisiana, 70112, United States
GSK Investigational Site
New Orleans, Louisiana, 70121, United States
GSK Investigational Site
Auburn, Maine, 04210, United States
GSK Investigational Site
Bangor, Maine, 04401, United States
GSK Investigational Site
Baltimore, Maryland, 21204, United States
GSK Investigational Site
Baltimore, Maryland, 21208, United States
GSK Investigational Site
Ayer, Massachusetts, 01432, United States
GSK Investigational Site
Boston, Massachusetts, 02115, United States
GSK Investigational Site
Haverhill, Massachusetts, 01831-2451, United States
GSK Investigational Site
Springfield, Massachusetts, 01107, United States
GSK Investigational Site
Waltham, Massachusetts, 02453, United States
GSK Investigational Site
Worcester, Massachusetts, 01605, United States
GSK Investigational Site
Worcester, Massachusetts, 01610, United States
GSK Investigational Site
Waterford, Michigan, 48328, United States
GSK Investigational Site
Gulfport, Mississippi, 39501, United States
GSK Investigational Site
Camden, New Jersey, 08103, United States
GSK Investigational Site
Hackensack, New Jersey, 07601, United States
GSK Investigational Site
Linwood, New Jersey, 08221, United States
GSK Investigational Site
Margate City, New Jersey, 08402, United States
GSK Investigational Site
Sea Girt, New Jersey, 08750, United States
GSK Investigational Site
Voorhees Township, New Jersey, 08043, United States
GSK Investigational Site
Buffalo, New York, 14209, United States
GSK Investigational Site
Flushing, New York, 11365, United States
GSK Investigational Site
Fulton, New York, 13069, United States
GSK Investigational Site
Kingston, New York, 12401, United States
GSK Investigational Site
Lancaster, New York, 14043, United States
GSK Investigational Site
Liverpool, New York, 13088, United States
GSK Investigational Site
New Hyde Park, New York, 11040, United States
GSK Investigational Site
New York, New York, 10021, United States
GSK Investigational Site
New York, New York, 10028, United States
GSK Investigational Site
New York, New York, 10032, United States
GSK Investigational Site
Rochester, New York, 14609, United States
GSK Investigational Site
Scarsdale, New York, 10583, United States
GSK Investigational Site
Syracuse, New York, 13202, United States
GSK Investigational Site
The Bronx, New York, 10461, United States
GSK Investigational Site
The Bronx, New York, 10467, United States
GSK Investigational Site
Tonawanda, New York, 14150, United States
GSK Investigational Site
Williamsville, New York, 14221, United States
GSK Investigational Site
Durham, North Carolina, 27710, United States
GSK Investigational Site
Hickory, North Carolina, 28601, United States
GSK Investigational Site
Raleigh, North Carolina, 27609, United States
GSK Investigational Site
Statesville, North Carolina, 28677, United States
GSK Investigational Site
Wilmington, North Carolina, 28412, United States
GSK Investigational Site
Winston-Salem, North Carolina, 27103, United States
GSK Investigational Site
Canton, Ohio, 44708, United States
GSK Investigational Site
Cincinnati, Ohio, 45246, United States
GSK Investigational Site
Cleveland, Ohio, 44106, United States
GSK Investigational Site
Columbus, Ohio, 43212, United States
GSK Investigational Site
Zanesville, Ohio, 43701, United States
GSK Investigational Site
Camp Hill, Pennsylvania, 17011, United States
GSK Investigational Site
Connellsville, Pennsylvania, 15425, United States
GSK Investigational Site
Downington, Pennsylvania, 19335, United States
GSK Investigational Site
Erie, Pennsylvania, 16505, United States
GSK Investigational Site
Fleetwood, Pennsylvania, 19522, United States
GSK Investigational Site
Morrisville, Pennsylvania, 19067, United States
GSK Investigational Site
Philadelphia, Pennsylvania, 19104, United States
GSK Investigational Site
Philadelphia, Pennsylvania, 19107, United States
GSK Investigational Site
Philipsburg, Pennsylvania, 16966, United States
GSK Investigational Site
Pittsburgh, Pennsylvania, 15206, United States
GSK Investigational Site
Pittsburgh, Pennsylvania, 15241, United States
GSK Investigational Site
West Grove, Pennsylvania, 19390, United States
GSK Investigational Site
Columbia, South Carolina, 29201, United States
GSK Investigational Site
Greer, South Carolina, 29651, United States
GSK Investigational Site
Summerville, South Carolina, 29485, United States
GSK Investigational Site
Bristol, Tennessee, 37620, United States
GSK Investigational Site
Jackson, Tennessee, 38301, United States
GSK Investigational Site
Memphis, Tennessee, 38163, United States
GSK Investigational Site
Nashville, Tennessee, 37212, United States
GSK Investigational Site
White River Junction, Utah, 05009, United States
GSK Investigational Site
Christiansburg, Virginia, 24073, United States
GSK Investigational Site
Falls Church, Virginia, 22044, United States
GSK Investigational Site
Fredericksburg, Virginia, 20401, United States
GSK Investigational Site
Richmond, Virginia, 23220, United States
GSK Investigational Site
Richmond, Virginia, 23294, United States
GSK Investigational Site
Salem, Virginia, 24153, United States
GSK Investigational Site
Springfield, Virginia, 22151, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 15, 2003
First Posted
May 16, 2003
Study Start
June 1, 2001
Primary Completion
April 1, 2004
Study Completion
April 1, 2004
Last Updated
April 14, 2015
Record last verified: 2015-04