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Effect Of Carvedilol Versus Metoprolol On Glycemic Control In Patients With Type II Diabetes And Hypertension
This study has been completed.
First Received: May 15, 2003   Last Updated: May 21, 2009   History of Changes
Sponsor: GlaxoSmithKline
Information provided by: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00060931
  Purpose

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


Condition Intervention Phase
Non-Insulin-Dependent Diabetes Mellitus
Hypertension
 Drug: carvedilol
Drug: metoprolol
 Phase IV

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study
Official Title: A Randomized, Double-Blind, Multicenter Study Comparing the Effects of Carvedilol and Metoprolol on Glycemic Control in Hypertensive Patients With Type II Diabetes Mellitus.

Resource links provided by NLM:

MedlinePlus related topics: Diabetes High Blood Pressure
Drug Information available for: Metoprolol Metoprolol Tartrate Carvedilol Metoprolol succinate Metoprolol fumarate
U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Change from baseline in HbA1c at 5 months [ Time Frame: 5 months ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 1210
Study Start Date: June 2001
  Eligibility

Ages Eligible for Study:   30 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00060931

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

No publications provided

Responsible Party: GSK ( Study Director )
Study ID Numbers: 105517/347
Study First Received: May 15, 2003
Last Updated: May 21, 2009
ClinicalTrials.gov Identifier: NCT00060931     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
Type 2 diabetes
hypertension
beta-blockers

Additional relevant MeSH terms:
Vasodilator Agents
Neurotransmitter Agents
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Therapeutic Uses
Adrenergic beta-Antagonists
Cardiovascular Diseases
Anti-Arrhythmia Agents
Carvedilol
Sympatholytics
Metabolic Diseases
Vascular Diseases
Diabetes Mellitus
 Endocrine System Diseases
Adrenergic alpha-Antagonists
Cardiovascular Agents
Metoprolol
Antihypertensive Agents
Pharmacologic Actions
Autonomic Agents
Metoprolol succinate
Diabetes Mellitus, Type 2
Adrenergic Antagonists
Peripheral Nervous System Agents
Glucose Metabolism Disorders
Hypertension

ClinicalTrials.gov processed this record on November 22, 2009



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