Clinical trial NCT00060918: Glycemic Control Of Carvedilol Versus Metoprolol In Patients With Type II Diabetes Mellitus And Hypertension
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypertension
Keywords: Type 2 diabetes
hypertension
beta-blockers
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2003-05-16
Enrollment: 1210
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: 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.


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.

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 values (glucose, insulin, triglycerides, cholesterol, and albumin:creatinine ratio) at 3 and 5 months.
timeFrame: 5 months
Other outcomes:
Locations:
city: Glendale
country: United States
facility: GSK Investigational Site
state: Arizona
city: Phoenix
country: United States
facility: GSK Investigational Site
state: Arizona
city: Phoenix
country: United States
facility: GSK Investigational Site
state: Arizona
city: Tucson
country: United States
facility: GSK Investigational Site
state: Arizona
city: Burlingame
country: United States
facility: GSK Investigational Site
state: California
city: Concord
country: United States
facility: GSK Investigational Site
state: California
city: Encinitas
country: United States
facility: GSK Investigational Site
state: California
city: Hemet
country: United States
facility: GSK Investigational Site
state: California
city: Long Beach
country: United States
facility: GSK Investigational Site
state: California
city: Orange
country: United States
facility: GSK Investigational Site
state: California
city: Pasadena
country: United States
facility: GSK Investigational Site
state: California
city: Riverside
country: United States
facility: GSK Investigational Site
state: California
city: San Diego
country: United States
facility: GSK Investigational Site
state: California
city: San Luis Obispo
country: United States
facility: GSK Investigational Site
state: California
city: Spring Valley
country: United States
facility: GSK Investigational Site
state: California
city: Aurora
country: United States
facility: GSK Investigational Site
state: Colorado
city: Denver
country: United States
facility: GSK Investigational Site
state: Colorado
city: Golden
country: United States
facility: GSK Investigational Site
state: Colorado
city: Panama City
country: United States
facility: GSK Investigational Site
state: Florida
city: St. Petersburg
country: United States
facility: GSK Investigational Site
state: Florida
city: Honolulu
country: United States
facility: GSK Investigational Site
state: Hawaii
city: Idaho Falls
country: United States
facility: GSK Investigational Site
state: Idaho
city: Chicago
country: United States
facility: GSK Investigational Site
state: Illinois
city: O'Fallon
country: United States
facility: GSK Investigational Site
state: Illinois
city: Elkhart
country: United States
facility: GSK Investigational Site
state: Indiana
city: Indianapolis
country: United States
facility: GSK Investigational Site
state: Indiana
city: Iowa City
country: United States
facility: GSK Investigational Site
state: Iowa
city: Kalamazoo
country: United States
facility: GSK Investigational Site
state: Michigan
city: Oak Park
country: United States
facility: GSK Investigational Site
state: Michigan
city: Minneapolis
country: United States
facility: GSK Investigational Site
state: Minnesota
city: Kansas City
country: United States
facility: GSK Investigational Site
state: Missouri
city: Kansas City
country: United States
facility: GSK Investigational Site
state: Missouri
city: St. Louis
country: United States
facility: GSK Investigational Site
state: Missouri
city: St. Louis
country: United States
facility: GSK Investigational Site
state: Missouri
city: Las Vegas
country: United States
facility: GSK Investigational Site
state: Nevada
city: Albuquerque
country: United States
facility: GSK Investigational Site
state: New Mexico
city: Oklahoma City
country: United States
facility: GSK Investigational Site
state: Oklahoma
city: Bend
country: United States
facility: GSK Investigational Site
state: Oregon
city: Oregon City
country: United States
facility: GSK Investigational Site
state: Oregon
city: Dallas
country: United States
facility: GSK Investigational Site
state: Texas
city: Fort Worth
country: United States
facility: GSK Investigational Site
state: Texas
city: Georgetown
country: United States
facility: GSK Investigational Site
state: Texas
city: Midland
country: United States
facility: GSK Investigational Site
state: Texas
city: San Antonio
country: United States
facility: GSK Investigational Site
state: Texas
city: San Antonio
country: United States
facility: GSK Investigational Site
state: Texas
city: The Colony
country: United States
facility: GSK Investigational Site
state: Texas
city: Ogden
country: United States
facility: GSK Investigational Site
state: Utah
city: Renton
country: United States
facility: GSK Investigational Site
state: Washington
city: Madison
country: United States
facility: GSK Investigational Site
state: Wisconsin
city: Milwaukee
country: United States
facility: GSK Investigational Site
state: Wisconsin
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: