Angina PectorisPhase 4NCT00225342
Study Protocol for Rosiglitazone Versus Gliclazide in Diabetics With Angina
A Phase 4 study testing Rosiglitazone and Gliclazide (Comparison drug) in people with Angina Pectoris and Diabetes Mellitus, Type 2, run by University of Glasgow at 1 site in United Kingdom.
Trial summary
The principle objective of the trial is to compare rosiglitazone to gliclazide in patients with type 2 diabetes mellitus and chronic stable angina to see how the subjects' angina status changes. Angina status will be measured via exercise tolerance testing, 24-hour ECG testing and angina quality of life questionnaire. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Angina Pectoris, Diabetes Mellitus, Type 2
- What is being tested?
- Rosiglitazone and Gliclazide (Comparison drug)
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Start not givento not given
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic stable angina with ongoing symptoms. (The treatment goal being an improvement in symptoms)
- Participants will have uncontrolled diabetes (Hba1c>7.5) on metformin monotherapy (so the diabetes is not over treated)
- Participants will be diabetic for less than 8 years.
Who cannot join
- Renal impairment (creatinine >130mmol/l)
- Hepatic Impairment (ALT>70U/l, AST>80U/l)
- Any clinical signs of heart failure
- Physical disability precluding treadmill exercise tolerance testing
- Abnormal resting ECG (left or right bundle-branch block, left or right ventricular hypertrophy, ventricular preexcitation, Q-wave myocardial infarction, digitalis therapy)
- Women of childbearing potential
- Women who are breastfeeding
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Cardiology Department, Glasgow Royal Infirmary
Glasgow, G4 0SF
About this study
Official title: Effects of Rosiglitazone and Sulphonylureas on Ischaemic Burden, Blood Pressure and Novel Risk Markers Inclusive of Vascular Function in Patients With Chronic Stable Angina and Type 2 Diabetes Mellitus: A Randomised, Double-Blinded Study.
The principle objective of the trial is to compare rosiglitazone to gliclazide in patients with type 2 diabetes mellitus and chronic stable angina to see how the subjects' angina status changes.
Angina status will be measured via exercise tolerance testing, 24-hour ECG testing and angina quality of life questionnaire.
Read the detailed description
Ischaemic heart disease is one of the main complications of type 2 diabetes mellitus, both in terms of morbidity and mortality. Reducing plasma glucose with hypoglycaemic agents has not been shown to improve cardiovascular mortality or morbidity. Chronic stable angina is a common problem in patients with type 2 diabetes mellitus.
We postulate that in subjects with uncontrolled type 2 diabetes mellitus (Hba1c >7.5%), on metformin therapy, and chronic stable angina that the addition of the insulin sensitiser, rosiglitazone to control their diabetes will improve their angina when compared to the addition of the hypoglycaemic agent gliclazide. This hypothesis is based on the fact that insulin resistance is an upstream mechanism common to both conditions.
We will randomise such patients to 3 months therapy of rosiglitazone or gliclazide for 3 months, comparing angina status before and after by way of full Bruce protocol exercise testing, 24 hour ST segment analysis and angina questionnaire.
- Conditions
- Angina Pectoris, Diabetes Mellitus, Type 2
- Being tested
- Rosiglitazone, Gliclazide (Comparison drug)
- Keywords
- Angina, Ischaemic heart disease, Diabetes
- Medical subject headings
- Angina Pectoris, Diabetes Mellitus, Type 2, Coronary Artery Disease, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RosiglitazoneDrug
Gliclazide (Comparison drug)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Angina status at 3 months
Secondary outcomes (4)
Pulse wave velocity at 3 months
Small vessel function at 3 months
Haemostatic markers at 3 months
Biochemical markers of inflammation at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2005 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Angina PectorisStudies of the same condition, open and under way.
- 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
- 60 participants
Sponsor and investigators
- Lead sponsor
- University of Glasgow
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline
- Investigators
- Naveed Sattar, MBChB PhD, Principal investigator, University of GlasgowStuart M Cobbe, MBChB MD, Principal investigator, University of Glasgow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00225342
- Sponsor's protocol ID
- GlasUniRosiGlic
- Other IDs
- Eudract No. 2004-000943-40
- Status last verified
- Sep 2005
- First submitted
- 21 Sep 2005
- Last updated
- 8 Sep 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Rosiglitazone and Sulphonylureas on Ischaemic Burden, Blood Pressure and Novel Risk Markers Inclusive of Vascular Function in Patients With Chronic Stable Angina and Type 2 Diabetes Mellitus: A Randomised, Double-Blinded Study.
- ClinicalTrials.gov ID
- NCT00225342
- Acronym / sponsor ID
- GlasUniRosiGlic
- Conditions
- Angina Pectoris, Diabetes Mellitus, Type 2
- Keywords
- Angina, Ischaemic heart disease, Diabetes
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 60 participants
- Lead sponsor
- University of GlasgowUniversity, hospital or other
- Collaborators
- GlaxoSmithKline
- First posted
- 23 Sep 2005 (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.
The principle objective of the trial is to compare rosiglitazone to gliclazide in patients with type 2 diabetes mellitus and chronic stable angina to see how the subjects' angina status changes.
Angina status will be measured via exercise tolerance testing, 24-hour ECG testing and angina quality of life questionnaire.
Detailed description
Ischaemic heart disease is one of the main complications of type 2 diabetes mellitus, both in terms of morbidity and mortality. Reducing plasma glucose with hypoglycaemic agents has not been shown to improve cardiovascular mortality or morbidity. Chronic stable angina is a common problem in patients with type 2 diabetes mellitus.
We postulate that in subjects with uncontrolled type 2 diabetes mellitus (Hba1c >7.5%), on metformin therapy, and chronic stable angina that the addition of the insulin sensitiser, rosiglitazone to control their diabetes will improve their angina when compared to the addition of the hypoglycaemic agent gliclazide. This hypothesis is based on the fact that insulin resistance is an upstream mechanism common to both conditions.
We will randomise such patients to 3 months therapy of rosiglitazone or gliclazide for 3 months, comparing angina status before and after by way of full Bruce protocol exercise testing, 24 hour ST segment analysis and angina questionnaire.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Chronic stable angina with ongoing symptoms. (The treatment goal being an improvement in symptoms)
- Participants will have uncontrolled diabetes (Hba1c>7.5) on metformin monotherapy (so the diabetes is not over treated)
- Participants will be diabetic for less than 8 years.
Key exclusion criteria (7 listed)
- Renal impairment (creatinine >130mmol/l)
- Hepatic Impairment (ALT>70U/l, AST>80U/l)
- Any clinical signs of heart failure
- Physical disability precluding treadmill exercise tolerance testing
- Abnormal resting ECG (left or right bundle-branch block, left or right ventricular hypertrophy, ventricular preexcitation, Q-wave myocardial infarction, digitalis 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 |
|---|---|---|
| Rosiglitazone | Drug | – |
| Gliclazide (Comparison drug) | Drug | – |
Primary outcome
Angina status at 3 months
4 secondary outcomes
Pulse wave velocity at 3 months
Small vessel function at 3 months
Haemostatic markers at 3 months
Biochemical markers of inflammation at 3 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2006.
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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.
Naveed Sattar, MBChB PhD principal investigator
University of Glasgow
Stuart M Cobbe, MBChB MD principal investigator
University of Glasgow
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Rosiglitazone and Gliclazide (Comparison drug) in people with Angina Pectoris and Diabetes Mellitus, Type 2, run by University of Glasgow at 1 site in United Kingdom.
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 3 inclusion and 7 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: withdrawn, as of the sponsor's last update on 8 Sep 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. 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 was withdrawn before enrolling participants, so there are no results.
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?
Angina status at 3 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 8 Sep 2006.