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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.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00060931
First received: May 15, 2003
Last updated: April 11, 2013
Last verified: August 2012
  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
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 Effects of Carvedilol and Metoprolol on Glycemic Control 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 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
Intervention Details:
    Drug: carvedilol Drug: metoprolol
    Other Names:
    • carvedilol
    • metoprolol
  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
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: NCT00060931

  Hide Study Locations
Locations
United States, Alabama
GSK Investigational Site
Birmingham, Alabama, United States, 35294-0012
GSK Investigational Site
Birmingham, Alabama, United States, 35294-2041
GSK Investigational Site
Columbia, Alabama, United States, 35051
GSK Investigational Site
Mobile, Alabama, United States, 36608
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, 20422
GSK Investigational Site
Washington, District of Columbia, United States, 20037
United States, Florida
GSK Investigational Site
Coral Gables, Florida, United States, 33134
GSK Investigational Site
Fort Lauderdale, Florida, United States, 33316
GSK Investigational Site
Gainesville, Florida, United States, 32605
GSK Investigational Site
Hollywood, Florida, United States, 33021
GSK Investigational Site
Hollywood, Florida, United States, 33023
GSK Investigational Site
Melbourne, Florida, United States, 32901
GSK Investigational Site
Miami, Florida, United States, 33133
GSK Investigational Site
Miami, Florida, United States, 33136
GSK Investigational Site
Ocala, Florida, United States, 34474
GSK Investigational Site
Saint Petersberg, Florida, United States, 33705
GSK Investigational Site
Sarasota, Florida, United States, 34239
GSK Investigational Site
Tamarac, Florida, United States, 33321
GSK Investigational Site
Tampa, Florida, United States, 33614
United States, Georgia
GSK Investigational Site
Fayetteville, Georgia, United States, 30214
GSK Investigational Site
Savannah, Georgia, United States, 31406
United States, Illinois
GSK Investigational Site
Chicago, Illinois, United States, 60616
United States, Indiana
GSK Investigational Site
Newburgh, Indiana, United States, 47630
GSK Investigational Site
Wabash, Indiana, United States, 46992
United States, Louisiana
GSK Investigational Site
New Orleans, Louisiana, United States, 70112
United States, Maine
GSK Investigational Site
Auburn, Maine, United States, 04210
United States, Massachusetts
GSK Investigational Site
Ayer, Massachusetts, United States, 01432
GSK Investigational Site
Waltham, Massachusetts, United States, 02453
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 York
GSK Investigational Site
Flushing, New York, United States, 11365
GSK Investigational Site
Kingston, New York, United States, 12401
GSK Investigational Site
New York, New York, United States, 10021
GSK Investigational Site
New York, New York, United States, 10032
GSK Investigational Site
Tonawanda, New York, United States, 14150
GSK Investigational Site
Williamsville, New York, United States, 14221
United States, North Carolina
GSK Investigational Site
Wilmington, North Carolina, United States, 28412
United States, Ohio
GSK Investigational Site
Canton, Ohio, United States, 44708
GSK Investigational Site
Cincinnati, Ohio, United States, 45246
GSK Investigational Site
Cleveland, Ohio, United States, 44106
GSK Investigational Site
Columbus, Ohio, United States, 43212
United States, Pennsylvania
GSK Investigational Site
Camp Hill, Pennsylvania, United States, 17011
GSK Investigational Site
Connellsville, Pennsylvania, United States, 15425
GSK Investigational Site
Erie, Pennsylvania, United States, 16505
GSK Investigational Site
Morrisville, Pennsylvania, United States, 19067
GSK Investigational Site
Philadelphia, Pennsylvania, United States, 19107
United States, Tennessee
GSK Investigational Site
Bristol, Tennessee, United States, 37620
GSK Investigational Site
Jackson, Tennessee, United States, 38301
GSK Investigational Site
Nashville, Tennessee, United States, 37212
United States, Utah
GSK Investigational Site
White River Junction, Utah, United States, 05009
United States, Virginia
GSK Investigational Site
Salem, Virginia, United States, 24153
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00060931     History of Changes
Other Study ID Numbers: 105517/347
Study First Received: May 15, 2003
Last Updated: April 11, 2013
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on November 23, 2014