HypertensionPhase 4NCT00060918
Glycemic Control Of Carvedilol Versus Metoprolol In Patients With Type II Diabetes Mellitus And Hypertension
A Phase 4 study testing carvedilol and metoprolol in people with Hypertension, run by GlaxoSmithKline at 50 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Hypertension
- What is being tested?
- carvedilol and metoprolol
- How many people
- 1,210 participants
- Where
- 50 sitesUnited States
- Study dates
- Jun 2001to Apr 2004
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- Patients using beta-blocker therapy.
Trial locations and contacts
50 sites in 1 country.
50 sites in 1 country
United States50 sites
GSK Investigational Site
Albuquerque, New Mexico, 87131
GSK Investigational Site
Aurora, Colorado, 80045
GSK Investigational Site
Bend, Oregon, 97701
GSK Investigational Site
Burlingame, California, 94010
GSK Investigational Site
Chicago, Illinois, 60612
GSK Investigational Site
Concord, California, 94520
GSK Investigational Site
Dallas, Texas, 75390
GSK Investigational Site
Denver, Colorado, 80220
GSK Investigational Site
Elkhart, Indiana, 46515
GSK Investigational Site
Encinitas, California, 92024
GSK Investigational Site
Fort Worth, Texas, 76104
GSK Investigational Site
Georgetown, Texas, 78626
GSK Investigational Site
Glendale, Arizona, 85306
GSK Investigational Site
Golden, Colorado, 80401
GSK Investigational Site
Hemet, California, 92543
GSK Investigational Site
Honolulu, Hawaii, 96813
GSK Investigational Site
Idaho Falls, Idaho, 83404
GSK Investigational Site
Indianapolis, Indiana, 46260
GSK Investigational Site
Iowa City, Iowa, 52242
GSK Investigational Site
Kalamazoo, Michigan, 49009
GSK Investigational Site
Kansas City, Missouri, 64106
GSK Investigational Site
Kansas City, Missouri, 64111
GSK Investigational Site
Las Vegas, Nevada, 89103
GSK Investigational Site
Long Beach, California, 90806
GSK Investigational Site
Madison, Wisconsin, 53792
GSK Investigational Site
Midland, Texas, 79705
GSK Investigational Site
Milwaukee, Wisconsin, 53151
GSK Investigational Site
Minneapolis, Minnesota, 55417
GSK Investigational Site
O'Fallon, Illinois, 62269
GSK Investigational Site
Oak Park, Michigan, 48237
GSK Investigational Site
Ogden, Utah, 84401
GSK Investigational Site
Oklahoma City, Oklahoma, 73112
GSK Investigational Site
Orange, California, 92868
GSK Investigational Site
Oregon City, Oregon, 97045
GSK Investigational Site
Panama City, Florida, 32401
GSK Investigational Site
Pasadena, California, 91105
GSK Investigational Site
Phoenix, Arizona, 85016
GSK Investigational Site
Phoenix, Arizona, 85050
GSK Investigational Site
Renton, Washington, 98055
GSK Investigational Site
Riverside, California, 92501
GSK Investigational Site
San Antonio, Texas, 78259
GSK Investigational Site
San Antonio, Texas, 78299
GSK Investigational Site
San Diego, California, 92102
GSK Investigational Site
San Luis Obispo, California, 93405
GSK Investigational Site
Spring Valley, California, 91978
GSK Investigational Site
St Louis, Missouri, 63110
GSK Investigational Site
St Louis, Missouri, 63128
GSK Investigational Site
St. Petersburg, Florida, 33701
GSK Investigational Site
The Colony, Texas, 75056
GSK Investigational Site
Tucson, Arizona, 85724
About this study
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.
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.
- Conditions
- Hypertension
- Being tested
- carvedilol, metoprolol
- Keywords
- Type 2 diabetes, hypertension, beta-blockers
- Medical subject headings
- Hypertension, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
carvedilolDrug
metoprololDrug
Also called carvedilol
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in HbA1c at 5 months
Measured: 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.
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2003 (estimated)
- Study startJun 2001
- Primary completionApr 2004
- Study completionApr 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 1,210 participants
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00060918
- Sponsor's protocol ID
- 105517/346
- Status last verified
- Jun 2012
- First submitted
- 15 May 2003
- Last updated
- 15 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00060918
- Acronym / sponsor ID
- 105517/346
- Conditions
- Hypertension
- Keywords
- Type 2 diabetes, hypertension, beta-blockers
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,210 participants
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Jun 2001
- Primary completion
- Apr 2004 (actual)
- Study completion
- Apr 2004 (actual)
- First posted
- 16 May 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (1 listed)
- Patients using beta-blocker therapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| carvedilol | Drug | – |
| metoprololAlso: carvedilol | Drug | – |
Primary outcome
Change from baseline in HbA1c at 5 months
Time frame: 5 months
1 secondary outcome
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.
Time frame: 5 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
50 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing carvedilol and metoprolol in people with Hypertension, run by GlaxoSmithKline at 50 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 50 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in HbA1c at 5 months (time frame: 5 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2015.