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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00060918
Recruitment Status : Completed
First Posted : May 16, 2003
Last Update Posted : April 15, 2015
Information provided by (Responsible Party):

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Hypertension Drug: carvedilol Drug: metoprolol Phase 4

Study Type : Interventional  (Clinical Trial)
Enrollment : 1210 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Multicenter Study Comparing the Glycemic Control Characteristics of Carvedilol and Metoprolol in Hypertensive Patients With Type II Diabetes Mellitus.
Study Start Date : June 2001
Actual Primary Completion Date : April 2004
Actual Study Completion Date : April 2004

Intervention Details:
    Drug: carvedilol Drug: metoprolol
    Other Name: carvedilol

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

Secondary Outcome Measures :
  1. 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 ]

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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00060918

  Hide Study Locations
United States, Arizona
GSK Investigational Site
Glendale, Arizona, United States, 85306
GSK Investigational Site
Phoenix, Arizona, United States, 85016
GSK Investigational Site
Phoenix, Arizona, United States, 85050
GSK Investigational Site
Tucson, Arizona, United States, 85724
United States, California
GSK Investigational Site
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
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Pasadena, California, United States, 91105
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Riverside, California, United States, 92501
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San Diego, California, United States, 92102
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San Luis Obispo, California, United States, 93405
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Spring Valley, California, United States, 91978
United States, Colorado
GSK Investigational Site
Aurora, Colorado, United States, 80045
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Denver, Colorado, United States, 80220
GSK Investigational Site
Golden, Colorado, United States, 80401
United States, Florida
GSK Investigational Site
Panama City, Florida, United States, 32401
GSK Investigational Site
St. Petersburg, Florida, United States, 33701
United States, Hawaii
GSK Investigational Site
Honolulu, Hawaii, United States, 96813
United States, Idaho
GSK Investigational Site
Idaho Falls, Idaho, United States, 83404
United States, Illinois
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Chicago, Illinois, United States, 60612
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O'Fallon, Illinois, United States, 62269
United States, Indiana
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Elkhart, Indiana, United States, 46515
GSK Investigational Site
Indianapolis, Indiana, United States, 46260
United States, Iowa
GSK Investigational Site
Iowa City, Iowa, United States, 52242
United States, Michigan
GSK Investigational Site
Kalamazoo, Michigan, United States, 49009
GSK Investigational Site
Oak Park, Michigan, United States, 48237
United States, Minnesota
GSK Investigational Site
Minneapolis, Minnesota, United States, 55417
United States, Missouri
GSK Investigational Site
Kansas City, Missouri, United States, 64106
GSK Investigational Site
Kansas City, Missouri, United States, 64111
GSK Investigational Site
St. Louis, Missouri, United States, 63110
GSK Investigational Site
St. Louis, Missouri, United States, 63128
United States, Nevada
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Las Vegas, Nevada, United States, 89103
United States, New Mexico
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Albuquerque, New Mexico, United States, 87131
United States, Oklahoma
GSK Investigational Site
Oklahoma City, Oklahoma, United States, 73112
United States, Oregon
GSK Investigational Site
Bend, Oregon, United States, 97701
GSK Investigational Site
Oregon City, Oregon, United States, 97045
United States, Texas
GSK Investigational Site
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, 78259
GSK Investigational Site
San Antonio, Texas, United States, 78299
GSK Investigational Site
The Colony, Texas, United States, 75056
United States, Utah
GSK Investigational Site
Ogden, Utah, United States, 84401
United States, Washington
GSK Investigational Site
Renton, Washington, United States, 98055
United States, Wisconsin
GSK Investigational Site
Madison, Wisconsin, United States, 53792
GSK Investigational Site
Milwaukee, Wisconsin, United States, 53151
Sponsors and Collaborators
Study Director: GSK Clinical Trials GlaxoSmithKline

Responsible Party: GlaxoSmithKline Identifier: NCT00060918     History of Changes
Other Study ID Numbers: 105517/346
First Posted: May 16, 2003    Key Record Dates
Last Update Posted: April 15, 2015
Last Verified: June 2012

Keywords provided by GlaxoSmithKline:
Type 2 diabetes

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Vascular Diseases
Cardiovascular Diseases
Anti-Arrhythmia Agents
Antihypertensive Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists