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 13, 2015
Last verified: April 2015
  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 ]

Enrollment: 501
Study Start Date: June 2001
Study Completion Date: April 2004
Primary Completion Date: April 2004 (Final data collection date for primary outcome measure)
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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00060931

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Locations
United States, Alabama
GSK Investigational Site
Birmingham, Alabama, United States, 35211
GSK Investigational Site
Birmingham, Alabama, United States, 35294-0012
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Birmingham, Alabama, United States, 35294-2041
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Columbia, Alabama, United States, 35051
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Mobile, Alabama, United States, 36608
United States, Connecticut
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Derby, Connecticut, United States, 06418
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Farmington, Connecticut, United States, 06030 - 1410
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Hartford, Connecticut, United States, 06106
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New Britain, Connecticut, United States, 06050
United States, Delaware
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Newark, Delaware, United States, 19713
United States, District of Columbia
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Washington, District of Columbia, United States, 20422
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Washington, District of Columbia, United States, 20037
United States, Florida
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Coral Gables, Florida, United States, 33134
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Fort Lauderdale, Florida, United States, 33308
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Fort Lauderdale, Florida, United States, 33316
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Fort Meyers, Florida, United States, 33907
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Gainesville, Florida, United States, 32605
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Hollywood, Florida, United States, 33021
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Hollywood, Florida, United States, 33023
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Inverness, Florida, United States, 34452
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Jacksonville, Florida, United States, 32205
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Jacksonville, Florida, United States, 32216
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Melbourne, Florida, United States, 32901
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Miami, Florida, United States, 33133
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Miami, Florida, United States, 33136
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Miami, Florida, United States, 33156
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Miami, Florida, United States, 33176
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Ocala, Florida, United States, 34471
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Saint Petersberg, Florida, United States, 33705
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Lexington, Kentucky, United States, 40508
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New Orleans, Louisiana, United States, 70112
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New Orleans, Louisiana, United States, 70121
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Bangor, Maine, United States, 04401
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Baltimore, Maryland, United States, 21208
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Baltimore, Maryland, United States, 21204
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Ayer, Massachusetts, United States, 01432
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Columbus, Ohio, United States, 43212
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Zanesville, Ohio, United States, 43701
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Camp Hill, Pennsylvania, United States, 17011
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Connellsville, Pennsylvania, United States, 15425
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Downington, Pennsylvania, United States, 19335
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Erie, Pennsylvania, United States, 16505
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Fleetwood, Pennsylvania, United States, 19522
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Morrisville, Pennsylvania, United States, 19067
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Philadelphia, Pennsylvania, United States, 19107
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Philadelphia, Pennsylvania, United States, 19104
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Philipsburgh, Pennsylvania, United States, 16966
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Fredericksburg, Virginia, United States, 20401
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Richmond, Virginia, United States, 23220
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Richmond, Virginia, United States, 23294
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Salem, Virginia, United States, 24153
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Springfield, Virginia, United States, 22151
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 13, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
hypertension
beta-blockers
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 July 29, 2015