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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.
Sponsored by: 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

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

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

  Hide Study Locations
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
GSK Investigational Site
Coral Gables, Florida, United States, 33134
GSK Investigational Site
Hollywood, Florida, United States, 33023
GSK Investigational Site
Inverness, Florida, United States, 34452
GSK Investigational Site
Gainesville, Florida, United States, 32605
GSK Investigational Site
Sarasota, Florida, United States, 34239
GSK Investigational Site
Pembroke Pines, Florida, United States, 33024
GSK Investigational Site
Fort Lauderdale, Florida, United States, 33316
GSK Investigational Site
Hollywood, Florida, United States, 33021
United States, Georgia
GSK Investigational Site
Augusta, Georgia, United States, 30901
GSK Investigational Site
Savannah, Georgia, United States, 31406
GSK Investigational Site
Fayetteville, Georgia, United States, 30214
GSK Investigational Site
Lawrenceville, Georgia, United States, 30045
United States, Illinois
GSK Investigational Site
West Evanston, Illinois, United States, 60202
GSK Investigational Site
Chicago, Illinois, United States, 60616
United States, Indiana
GSK Investigational Site
Wabash, Indiana, United States, 46992
GSK Investigational Site
Newburgh, Indiana, United States, 47630
United States, Kentucky
GSK Investigational Site
Lexington, Kentucky, United States, 40508
United States, Louisiana
GSK Investigational Site
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
GSK Investigational Site
Baltimore, Maryland, United States, 21208
GSK Investigational Site
Baltimore, Maryland, United States, 21204
United States, Massachusetts
GSK Investigational Site
Worcester, Massachusetts, United States, 01610
GSK Investigational Site
Boston, Massachusetts, United States, 02115
GSK Investigational Site
Springfield, Massachusetts, United States, 01107
GSK Investigational Site
Ayer, Massachusetts, United States, 01432
GSK Investigational Site
Worcester, Massachusetts, United States, 01605
GSK Investigational Site
Haverhill, Massachusetts, United States, 01831-2451
United States, Michigan
GSK Investigational Site
Waterford, Michigan, United States, 48328
United States, Mississippi
GSK Investigational Site
Gulfport, Mississippi, United States, 39501
United States, New Jersey
GSK Investigational Site
Hackensack, New Jersey, United States, 07601
GSK Investigational Site
Voorhees, New Jersey, United States, 08043
GSK Investigational Site
Margate, New Jersey, United States, 08402
GSK Investigational Site
Linwood, New Jersey, United States, 08221
GSK Investigational Site
Sea Girt, New Jersey, United States, 08750
United States, New York
GSK Investigational Site
Rochester, New York, United States, 14609
GSK Investigational Site
Liverpool, New York, United States, 13088
GSK Investigational Site
Scarsdale, New York, United States, 10583
GSK Investigational Site
Williamsville, New York, United States, 14221
GSK Investigational Site
Bronx, New York, United States, 10461
GSK Investigational Site
Kingston, New York, United States, 12401
GSK Investigational Site
Lancaster, New York, United States, 14043
GSK Investigational Site
Tonawanda, New York, United States, 14150
GSK Investigational Site
Buffalo, New York, United States, 14209
GSK Investigational Site
Fulton, New York, United States, 13069
GSK Investigational Site
New York, New York, United States, 10028
GSK Investigational Site
Flushing, New York, United States, 11365
GSK Investigational Site
Syracuse, New York, United States, 13202
GSK Investigational Site
New Hyde Park, New York, United States, 11040
GSK Investigational Site
New York, New York, United States, 10021
GSK Investigational Site
Bronx, New York, United States, 10467
United States, North Carolina
GSK Investigational Site
Winston-Salem, North Carolina, United States, 27103
GSK Investigational Site
Statesville, North Carolina, United States, 28677
GSK Investigational Site
Raleigh, North Carolina, United States, 27609
GSK Investigational Site
Hickory, North Carolina, United States, 28601
GSK Investigational Site
Wilmington, North Carolina, United States, 28412
United States, Ohio
GSK Investigational Site
Cleveland, Ohio, United States, 44106
GSK Investigational Site
Zanesville, Ohio, United States, 43701
GSK Investigational Site
Canton, Ohio, United States, 44708
GSK Investigational Site
Cincinnati, Ohio, United States, 45246
GSK Investigational Site
Columbus, Ohio, United States, 43212
United States, Pennsylvania
GSK Investigational Site
Morrisville, Pennsylvania, United States, 19067
GSK Investigational Site
Erie, Pennsylvania, United States, 16505
GSK Investigational Site
Connellsville, Pennsylvania, United States, 15425
GSK Investigational Site
Philadelphia, Pennsylvania, United States, 19107
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
Downington, Pennsylvania, United States, 19335
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
GSK Investigational Site
Memphis, Tennessee, United States, 38163
GSK Investigational Site
Nashville, Tennessee, United States, 37212
GSK Investigational Site
Bristol, Tennessee, United States, 37620
United States, Utah
GSK Investigational Site
White River Junction, Utah, United States, 05009
United States, Virginia
GSK Investigational Site
Christiansburg, Virginia, United States, 24073
GSK Investigational Site
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

Responsible Party: GSK ( Study Director )
Study ID Numbers: 105517/347
Study First Received: May 15, 2003
Last Updated: October 15, 2008
ClinicalTrials.gov Identifier: NCT00060931  
Health Authority: United States: Food and Drug Administration

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

Study placed in the following topic categories:
Metabolic Diseases
Metoprolol succinate
Diabetes Mellitus, Type 2
Vascular Diseases
Diabetes Mellitus
Endocrine System Diseases
 Endocrinopathy
Metoprolol
Metabolic disorder
Glucose Metabolism Disorders
Carvedilol
Hypertension

Additional relevant MeSH terms:
Vasodilator Agents
Neurotransmitter Agents
Sympatholytics
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Adrenergic alpha-Antagonists
Cardiovascular Agents
Antihypertensive Agents
 Pharmacologic Actions
Autonomic Agents
Therapeutic Uses
Adrenergic beta-Antagonists
Cardiovascular Diseases
Adrenergic Antagonists
Peripheral Nervous System Agents
Anti-Arrhythmia Agents

ClinicalTrials.gov processed this record on January 16, 2009



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