Clinical trial NCT00060931: Effect Of Carvedilol Versus Metoprolol On Glycemic Control In Patients With Type II Diabetes And Hypertension
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypertension
Keywords: hypertension
beta-blockers
Type 2 diabetes
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2003-05-16
Enrollment: 501
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Evaluation of the effect of two different antihypertensive treatments on control of glucose in Type II diabetic patients with high blood pressure


Eligibility 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.

Primary outcomes:
measure: Change from baseline in HbA1c at 5 months
timeFrame: 5 months
Secondary outcomes:
measure: 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.
timeFrame: 5 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: GSK Investigational Site
state: Alabama
city: Birmingham
country: United States
facility: GSK Investigational Site
state: Alabama
city: Birmingham
country: United States
facility: GSK Investigational Site
state: Alabama
city: Columbia
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state: Alabama
city: Mobile
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state: Alabama
city: Derby
country: United States
facility: GSK Investigational Site
state: Connecticut
city: Farmington
country: United States
facility: GSK Investigational Site
state: Connecticut
city: Hartford
country: United States
facility: GSK Investigational Site
state: Connecticut
city: New Britain
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state: Connecticut
city: Newark
country: United States
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state: Delaware
city: Washington
country: United States
facility: GSK Investigational Site
state: District of Columbia
city: Washington
country: United States
facility: GSK Investigational Site
state: District of Columbia
city: Coral Gables
country: United States
facility: GSK Investigational Site
state: Florida
city: Fort Lauderdale
country: United States
facility: GSK Investigational Site
state: Florida
city: Fort Lauderdale
country: United States
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city: Fort Meyers
country: United States
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city: Gainesville
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city: Hollywood
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city: Jacksonville
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city: Jacksonville
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city: Miami
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city: Augusta
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facility: GSK Investigational Site
state: Georgia
city: Fayetteville
country: United States
facility: GSK Investigational Site
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city: Lawrenceville
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city: Boston
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city: Bronx
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city: Bronx
country: United States
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city: New Hyde Park
country: United States
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state: New York
city: New York
country: United States
facility: GSK Investigational Site
state: New York
city: New York
country: United States
facility: GSK Investigational Site
state: New York
city: New York
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state: New York
city: Rochester
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city: Scarsdale
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city: Tonawanda
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state: New York
city: Durham
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state: North Carolina
city: Hickory
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Raleigh
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state: North Carolina
city: Statesville
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facility: GSK Investigational Site
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city: Wilmington
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Winston-Salem
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facility: GSK Investigational Site
state: North Carolina
city: Canton
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facility: GSK Investigational Site
state: Ohio
city: Cincinnati
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city: Camp Hill
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state: Pennsylvania
city: Connellsville
country: United States
facility: GSK Investigational Site
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state: Pennsylvania
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state: Pennsylvania
city: Philadelphia
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facility: GSK Investigational Site
state: Pennsylvania
city: Philadelphia
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state: Pennsylvania
city: Philipsburgh
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Pittsburgh
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Pittsburgh
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: West Grove
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Columbia
country: United States
facility: GSK Investigational Site
state: South Carolina
city: Greer
country: United States
facility: GSK Investigational Site
state: South Carolina
city: Summerville
country: United States
facility: GSK Investigational Site
state: South Carolina
city: Bristol
country: United States
facility: GSK Investigational Site
state: Tennessee
city: Jackson
country: United States
facility: GSK Investigational Site
state: Tennessee
city: Memphis
country: United States
facility: GSK Investigational Site
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city: Nashville
country: United States
facility: GSK Investigational Site
state: Tennessee
city: White River Junction
country: United States
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state: Utah
city: Christiansburg
country: United States
facility: GSK Investigational Site
state: Virginia
city: Falls Church
country: United States
facility: GSK Investigational Site
state: Virginia
city: Fredericksburg
country: United States
facility: GSK Investigational Site
state: Virginia
city: Richmond
country: United States
facility: GSK Investigational Site
state: Virginia
city: Richmond
country: United States
facility: GSK Investigational Site
state: Virginia
city: Salem
country: United States
facility: GSK Investigational Site
state: Virginia
city: Springfield
country: United States
facility: GSK Investigational Site
state: Virginia
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: