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Glycemic Control Of Carvedilol Versus Metoprolol In Patients With Type II Diabetes Mellitus 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: NCT00060918
  Purpose

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 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 Glycemic Control Characteristics of Carvedilol and Metoprolol 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 values (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).
  • 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00060918

  Hide Study Locations
Locations
United States, Arizona
GSK Investigational Site
Scottsdale, Arizona, United States, 85251
GSK Investigational Site
Phoenix, Arizona, United States, 85016
GSK Investigational Site
Phoenix, Arizona, United States, 85006
GSK Investigational Site
Tucson, Arizona, United States, 85724
GSK Investigational Site
Phoenix, Arizona, United States, 85012
GSK Investigational Site
Phoenix, Arizona, United States, 85050
GSK Investigational Site
Tucson, Arizona, United States, 85704
GSK Investigational Site
Phoenix, Arizona, United States, 85048
GSK Investigational Site
Phoenix, Arizona, United States, 85006
GSK Investigational Site
Phoenix, Arizona, United States, 85014
GSK Investigational Site
Phoenix, Arizona, United States, 85013
United States, California
GSK Investigational Site
Irvine, California, United States, 92618
GSK Investigational Site
Concord, California, United States, 94520
GSK Investigational Site
Orange, California, United States, 92868
GSK Investigational Site
Carmichael, California, United States, 95608
GSK Investigational Site
Los Angeles, California, United States, 90024
GSK Investigational Site
San Luis Obispo, California, United States, 93405
GSK Investigational Site
Spring Valley, California, United States, 91978
GSK Investigational Site
Stanford, California, United States, 94305
GSK Investigational Site
Long Beach, California, United States, 90806
GSK Investigational Site
Hemet, California, United States, 92543
GSK Investigational Site
Riverside, California, United States, 92501
GSK Investigational Site
Encinitas, California, United States, 92024
GSK Investigational Site
Santa Rosa, California, United States, 95405
GSK Investigational Site
Los Angeles, California, United States, 90057
GSK Investigational Site
Walnut Creek, California, United States, 94598
GSK Investigational Site
Burlingame, California, United States, 94010
GSK Investigational Site
Escondido, California, United States, 92021
GSK Investigational Site
San Diego, California, United States, 92102
United States, Colorado
GSK Investigational Site
Loveland, Colorado, United States, 80538
GSK Investigational Site
Denver, Colorado, United States, 80220
GSK Investigational Site
Aurora, Colorado, United States, 80045
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
GSK Investigational Site
Miami, Florida, United States, 33173
United States, Hawaii
GSK Investigational Site
Honolulu, Hawaii, United States, 96814
GSK Investigational Site
Honolulu, Hawaii, United States, 96813
United States, Idaho
GSK Investigational Site
Hayden Lake, Idaho, United States, 83835
GSK Investigational Site
IDAHO FALLS, Idaho, United States, 83404
United States, Illinois
GSK Investigational Site
Chicago, Illinois, United States, 60611
GSK Investigational Site
Chicago, Illinois, United States, 60612
GSK Investigational Site
O'Fallon, Illinois, United States, 62269
GSK Investigational Site
Aurora, Illinois, United States, 60506
GSK Investigational Site
Chicago, Illinois, United States, 60607
GSK Investigational Site
Melrose Park, Illinois, United States, 60160
GSK Investigational Site
Elk Grove Village, Illinois, United States, 60007
United States, Indiana
GSK Investigational Site
Elkhart, Indiana, United States, 46515
GSK Investigational Site
Evansville, Indiana, United States, 47713
GSK Investigational Site
Indianapolis, Indiana, United States, 46260
United States, Iowa
GSK Investigational Site
Des Moines, Iowa, United States, 50325-7046
GSK Investigational Site
Des Moines, Iowa, United States, 50314
GSK Investigational Site
Iowa City, Iowa, United States, 52242
United States, Louisiana
GSK Investigational Site
Morgan City, Louisiana, United States, 70380
United States, Michigan
GSK Investigational Site
Ann Arbor, Michigan, United States, 48106
GSK Investigational Site
Kalamazoo, Michigan, United States, 49009
GSK Investigational Site
Oak Park, Michigan, United States, 48237
United States, Minnesota
GSK Investigational Site
Brooklyn Center, Minnesota, United States, 55430
GSK Investigational Site
St. Paul, Minnesota, United States, 55102
GSK Investigational Site
Minneapolis, Minnesota, United States, 55417
GSK Investigational Site
Chaska, Minnesota, United States, 55318
GSK Investigational Site
Minneapolis, Minnesota, United States, 55416
United States, Missouri
GSK Investigational Site
St. Louis, Missouri, United States, 63104
GSK Investigational Site
St. Louis, Missouri, United States, 63110
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, 63128
GSK Investigational Site
Springfield, Missouri, United States, 65807
GSK Investigational Site
St. Louis, Missouri, United States, 63131
United States, Nebraska
GSK Investigational Site
Omaha, Nebraska, United States, 68105
United States, Nevada
GSK Investigational Site
Las Vegas, Nevada, United States, 89103
GSK Investigational Site
Henderson, Nevada, United States, 89014
United States, New Mexico
GSK Investigational Site
Albuquerque, New Mexico, United States, 87131
GSK Investigational Site
Albuquerque, New Mexico, United States, 87112
United States, North Dakota
GSK Investigational Site
Wishek, North Dakota, United States, 58495
United States, Oklahoma
GSK Investigational Site
Oklahoma City, Oklahoma, United States, 73112
GSK Investigational Site
Tulsa, Oklahoma, United States, 74136
United States, Oregon
GSK Investigational Site
Portland, Oregon, United States, 97219
GSK Investigational Site
Oregon City, Oregon, United States, 97045
GSK Investigational Site
Eugene, Oregon, United States, 97401
GSK Investigational Site
Bend, Oregon, United States, 97701
United States, South Carolina
GSK Investigational Site
Bamberg, South Carolina, United States, 29003
United States, Texas
GSK Investigational Site
North Richland Hills, Texas, United States, 76180
GSK Investigational Site
Georgetown, Texas, United States, 78626
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
GSK Investigational Site
Midland, Texas, United States, 79705
GSK Investigational Site
Houston, Texas, United States, 77030
GSK Investigational Site
Dallas, Texas, United States, 75231
GSK Investigational Site
San Antonio, Texas, United States, 78237
GSK Investigational Site
Houston, Texas, United States, 77055
GSK Investigational Site
Austin, Texas, United States, 78746
GSK Investigational Site
Dallas, Texas, United States, 75230
GSK Investigational Site
Arlington, Texas, United States, 76017
GSK Investigational Site
Austin, Texas, United States, 78750
GSK Investigational Site
Galveston, Texas, United States, 77555
GSK Investigational Site
Fort Worth, Texas, United States, 76104
GSK Investigational Site
Dallas, Texas, United States, 75235
GSK Investigational Site
San Antonio, Texas, United States, 78221
United States, Utah
GSK Investigational Site
Ogden, Utah, United States, 84401
United States, Washington
GSK Investigational Site
Olympia, Washington, United States, 98502
GSK Investigational Site
Burien, Washington, United States, 98166
GSK Investigational Site
Renton, Washington, United States, 98055
GSK Investigational Site
Tacoma, Washington, United States, 98499
GSK Investigational Site
Kirkland, Washington, United States, 98034
United States, Wisconsin
GSK Investigational Site
Oregon, Wisconsin, United States, 53575
GSK Investigational Site
Madison, Wisconsin, United States, 53792
GSK Investigational Site
Milwaukee, Wisconsin, United States, 53209-0996
GSK Investigational Site
Milwaukee, Wisconsin, United States, 53151
Canada, British Columbia
GSK Investigational Site
Vancouver, British Columbia, Canada, V6T 2B5
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: 105517/346
Study First Received: May 15, 2003
Last Updated: May 21, 2009
ClinicalTrials.gov Identifier: NCT00060918     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 30, 2009



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