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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00060918
First received: May 15, 2003
Last updated: April 11, 2013
Last verified: June 2012
  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
Hypertension
Drug: carvedilol
Drug: metoprolol
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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.

Resource links provided by NLM:


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
Intervention Details:
    Drug: carvedilol Drug: metoprolol
    Other Names:
    • metoprolol
    • carvedilol
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00060918

  Hide Study Locations
Locations
United States, Arizona
GSK Investigational Site
Glendale, Arizona, United States, 85306
GSK Investigational Site
Phoenix, Arizona, United States, 85050
GSK Investigational Site
Phoenix, Arizona, United States, 85016
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
GSK Investigational Site
Pasadena, California, United States, 91105
GSK Investigational Site
Riverside, California, United States, 92501
GSK Investigational Site
San Diego, California, United States, 92102
GSK Investigational Site
San Luis Obispo, California, United States, 93405
GSK Investigational Site
Spring Valley, California, United States, 91978
United States, Colorado
GSK Investigational Site
Aurora, Colorado, United States, 80045
GSK Investigational Site
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
GSK Investigational Site
Chicago, Illinois, United States, 60612
GSK Investigational Site
O'Fallon, Illinois, United States, 62269
United States, Indiana
GSK Investigational Site
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, 64111
GSK Investigational Site
Kansas City, Missouri, United States, 64106
GSK Investigational Site
St. Louis, Missouri, United States, 63110
GSK Investigational Site
St. Louis, Missouri, United States, 63128
United States, Nevada
GSK Investigational Site
Las Vegas, Nevada, United States, 89103
United States, New Mexico
GSK Investigational Site
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, 78299
GSK Investigational Site
San Antonio, Texas, United States, 78259
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
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00060918     History of Changes
Other Study ID Numbers: 105517/346
Study First Received: May 15, 2003
Last Updated: April 11, 2013
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Hypertension
Diabetes Mellitus
Diabetes Mellitus, Type 2
Vascular Diseases
Cardiovascular Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Metoprolol
Carvedilol
Metoprolol succinate
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Antihypertensive Agents
Sympatholytics
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

ClinicalTrials.gov processed this record on September 30, 2014