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

Overview[ - collapse ][ - ]

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.
ConditionHypertension
InterventionDrug: carvedilol
Drug: metoprolol
PhasePhase 4
SponsorGlaxoSmithKline
Responsible PartyGlaxoSmithKline
ClinicalTrials.gov IdentifierNCT00060918
First ReceivedMay 15, 2003
Last UpdatedApril 11, 2013
Last verifiedJune 2012

Tracking Information[ + expand ][ + ]

First Received DateMay 15, 2003
Last Updated DateApril 11, 2013
Start DateJune 2001
Estimated Primary Completion DateNot Provided
Current Primary Outcome MeasuresChange from baseline in HbA1c at 5 months [Time Frame: 5 months]
Current Secondary Outcome MeasuresBlood 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]

Descriptive Information[ + expand ][ + ]

Brief TitleGlycemic Control Of Carvedilol Versus Metoprolol In Patients With Type II Diabetes Mellitus And Hypertension
Official TitleA Randomized, Double-Blind, Multicenter Study Comparing the Glycemic Control Characteristics of Carvedilol and Metoprolol in Hypertensive Patients With Type II Diabetes Mellitus.
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.
Detailed DescriptionNot Provided
Study TypeInterventional
Study PhasePhase 4
Study DesignAllocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
ConditionHypertension
InterventionDrug: carvedilol
Drug: metoprolol
Other Names:
  • metoprolol
  • carvedilol
Study Arm (s)Not Provided

Recruitment Information[ + expand ][ + ]

Recruitment StatusCompleted
Estimated Enrollment1210
Estimated Completion DateNot Provided
Estimated Primary Completion DateNot Provided
Eligibility 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.
GenderBoth
Ages30 Years
Accepts Healthy VolunteersNo
ContactsNot Provided
Location CountriesUnited States

Administrative Information[ + expand ][ + ]

NCT Number NCT00060918
Other Study ID Numbers105517/346
Has Data Monitoring CommitteeNo
Information Provided ByGlaxoSmithKline
Study SponsorGlaxoSmithKline
CollaboratorsNot Provided
Investigators Study Director: GSK Clinical Trials GlaxoSmithKline
Verification DateJune 2012

Locations[ + expand ][ + ]

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
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
GSK Investigational Site
Aurora, Colorado, United States, 80045
GSK Investigational Site
Denver, Colorado, United States, 80220
GSK Investigational Site
Golden, Colorado, United States, 80401
GSK Investigational Site
Panama City, Florida, United States, 32401
GSK Investigational Site
St. Petersburg, Florida, United States, 33701
GSK Investigational Site
Honolulu, Hawaii, United States, 96813
GSK Investigational Site
Idaho Falls, Idaho, United States, 83404
GSK Investigational Site
Chicago, Illinois, United States, 60612
GSK Investigational Site
O'Fallon, Illinois, United States, 62269
GSK Investigational Site
Elkhart, Indiana, United States, 46515
GSK Investigational Site
Indianapolis, Indiana, United States, 46260
GSK Investigational Site
Iowa City, Iowa, United States, 52242
GSK Investigational Site
Kalamazoo, Michigan, United States, 49009
GSK Investigational Site
Oak Park, Michigan, United States, 48237
GSK Investigational Site
Minneapolis, Minnesota, United States, 55417
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
GSK Investigational Site
Las Vegas, Nevada, United States, 89103
GSK Investigational Site
Albuquerque, New Mexico, United States, 87131
GSK Investigational Site
Oklahoma City, Oklahoma, United States, 73112
GSK Investigational Site
Bend, Oregon, United States, 97701
GSK Investigational Site
Oregon City, Oregon, United States, 97045
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
GSK Investigational Site
Ogden, Utah, United States, 84401
GSK Investigational Site
Renton, Washington, United States, 98055
GSK Investigational Site
Madison, Wisconsin, United States, 53792
GSK Investigational Site
Milwaukee, Wisconsin, United States, 53151