Glycemic Control Of Carvedilol Versus Metoprolol In Patients With Type II Diabetes Mellitus And Hypertension
A Randomized, Double-Blind, Multicenter Study Comparing the Glycemic Control Characteristics of Carvedilol and Metoprolol in Hypertensive Patients With Type II Diabetes Mellitus.
1 other identifier
interventional
1,210
1 country
50
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 hypertension
Started Jun 2001
Typical duration for phase_4 hypertension
50 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2001
CompletedFirst Submitted
Initial submission to the registry
May 15, 2003
CompletedFirst Posted
Study publicly available on registry
May 16, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2004
CompletedApril 15, 2015
June 1, 2012
2.8 years
May 15, 2003
April 14, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from baseline in HbA1c at 5 months
5 months
Secondary Outcomes (1)
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.
5 months
Interventions
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- Patients using beta-blocker therapy.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (50)
GSK Investigational Site
Glendale, Arizona, 85306, United States
GSK Investigational Site
Phoenix, Arizona, 85016, United States
GSK Investigational Site
Phoenix, Arizona, 85050, United States
GSK Investigational Site
Tucson, Arizona, 85724, United States
GSK Investigational Site
Burlingame, California, 94010, United States
GSK Investigational Site
Concord, California, 94520, United States
GSK Investigational Site
Encinitas, California, 92024, United States
GSK Investigational Site
Hemet, California, 92543, United States
GSK Investigational Site
Long Beach, California, 90806, United States
GSK Investigational Site
Orange, California, 92868, United States
GSK Investigational Site
Pasadena, California, 91105, United States
GSK Investigational Site
Riverside, California, 92501, United States
GSK Investigational Site
San Diego, California, 92102, United States
GSK Investigational Site
San Luis Obispo, California, 93405, United States
GSK Investigational Site
Spring Valley, California, 91978, United States
GSK Investigational Site
Aurora, Colorado, 80045, United States
GSK Investigational Site
Denver, Colorado, 80220, United States
GSK Investigational Site
Golden, Colorado, 80401, United States
GSK Investigational Site
Panama City, Florida, 32401, United States
GSK Investigational Site
St. Petersburg, Florida, 33701, United States
GSK Investigational Site
Honolulu, Hawaii, 96813, United States
GSK Investigational Site
Idaho Falls, Idaho, 83404, United States
GSK Investigational Site
Chicago, Illinois, 60612, United States
GSK Investigational Site
O'Fallon, Illinois, 62269, United States
GSK Investigational Site
Elkhart, Indiana, 46515, United States
GSK Investigational Site
Indianapolis, Indiana, 46260, United States
GSK Investigational Site
Iowa City, Iowa, 52242, United States
GSK Investigational Site
Kalamazoo, Michigan, 49009, United States
GSK Investigational Site
Oak Park, Michigan, 48237, United States
GSK Investigational Site
Minneapolis, Minnesota, 55417, United States
GSK Investigational Site
Kansas City, Missouri, 64106, United States
GSK Investigational Site
Kansas City, Missouri, 64111, United States
GSK Investigational Site
St Louis, Missouri, 63110, United States
GSK Investigational Site
St Louis, Missouri, 63128, United States
GSK Investigational Site
Las Vegas, Nevada, 89103, United States
GSK Investigational Site
Albuquerque, New Mexico, 87131, United States
GSK Investigational Site
Oklahoma City, Oklahoma, 73112, United States
GSK Investigational Site
Bend, Oregon, 97701, United States
GSK Investigational Site
Oregon City, Oregon, 97045, United States
GSK Investigational Site
Dallas, Texas, 75390, United States
GSK Investigational Site
Fort Worth, Texas, 76104, United States
GSK Investigational Site
Georgetown, Texas, 78626, United States
GSK Investigational Site
Midland, Texas, 79705, United States
GSK Investigational Site
San Antonio, Texas, 78259, United States
GSK Investigational Site
San Antonio, Texas, 78299, United States
GSK Investigational Site
The Colony, Texas, 75056, United States
GSK Investigational Site
Ogden, Utah, 84401, United States
GSK Investigational Site
Renton, Washington, 98055, United States
GSK Investigational Site
Madison, Wisconsin, 53792, United States
GSK Investigational Site
Milwaukee, Wisconsin, 53151, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 15, 2003
First Posted
May 16, 2003
Study Start
June 1, 2001
Primary Completion
April 1, 2004
Study Completion
April 1, 2004
Last Updated
April 15, 2015
Record last verified: 2012-06