Coronary Artery DiseasePhase 4CAMERANCT00723307
Carotid Atherosclerosis: MEtformin for Insulin ResistAnce Study
A Phase 4 study testing Metformin in people with Coronary Artery Disease, run by Professor Naveed Sattar at 1 site in United Kingdom.
Trial summary
Hypothesis: Treatment with metformin in overweight non-diabetic individuals with coronary heart disease and on standard cardiovascular risk reducing agents including statins will have a beneficial impact on carotid artery atherosclerosis compared to placebo. Read more about this study
- Who is it for?
- Ages 35 to 75 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Metformin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 173 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Feb 2009to Dec 2012
- 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 35 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Proven coronary heart disease (prior acute coronary syndrome, prior CABG or angiographically proven CHD)
- Aged 35-75 years
- Elevated waist circumference as per the International Diabetes Foundation criteria (94 cm in men and 80 cm in women)
- All patients will be on statin
Who cannot join
- Pregnancy and/or lactation at screening
- Premenopausal woman not on contraception
- Known or newly diagnosed diabetes mellitus on oral glucose tolerance testing (OGTT will be performed on subjects with HbA1C 6.0-6.9% and fasting plasma glucose [FPG] < 7.0 mmol/L at screening18)
- Screening results: HbA1C ≥ 7.0% and/or fasting plasma glucose ≥ 7.0 mmol/L
- Patients with Acute Coronary Syndrome within the last 3 months
- Clinically unstable heart failure
- Uncontrolled angina
- Contraindications to metformin
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Glasgow Clinical Research Facility, NHS Greater Glasgow and Clyde
Glasgow, G11 6NT
About this study
Official title: A Randomised Placebo-controlled Trial of Metformin on Progression of Carotid Atherosclerosis in Non-diabetic Patients With Cardiovascular Disease Treated With Conventional Risk Reducing Agents
Hypothesis: Treatment with metformin in overweight non-diabetic individuals with coronary heart disease and on standard cardiovascular risk reducing agents including statins will have a beneficial impact on carotid artery atherosclerosis compared to placebo.
Rationale: Once subjects have a heart attack, they remain at much higher than average risk of another heart attack and stroke, despite the best current therapies to lower their cholesterol and blood pressure and thin their blood. Many subjects with heart disease also have problems metabolising (i.e. processing) sugar even if they do not have diabetes. There is some evidence that metformin, a drug which improves sugar metabolism, decreases the risk of future heart attacks in diabetic patients. However, whether metformin further reduces the risk of heart disease beyond established treatments in people without diabetes is unknown.
Method: The investigators will test the ability metformin, a drug with proven safety, to slow the progression of furring up (known as atherosclerosis) of blood vessels in non-diabetic subjects with heart disease. This will be achieved by treating 2 groups of subjects with metformin and placebo pills respectively. To measure atherosclerosis, the investigators will carry out ultrasound scans of the big blood vessels in the neck at the start of the study, after 1 year and after 1.5 years of therapy.The investigators will then be able to assess whether metformin has had a beneficial impact.
- Conditions
- Coronary Artery Disease
- Being tested
- Metformin, Placebo
- Keywords
- No diabetes mellitus, Elevated waist circumference
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetforminDrug
Also called Glucophage, Glucophage SR, Bolamyn SR
White film-coated tablets, 850mg tablet twice daily, 1.5 years duration
PlaceboDrug
Also called Dummy pill
White coated tablet; one tablet twice daily; 1.5 years duration
| Study group | Role | What they receive |
|---|---|---|
| Metformin | Experimental | Not described Receives: Drug: Metformin |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in progression of carotid intima-media thickness (measured in millimetres) between groups treated with metformin and placebo
Measured: 1.5 years
Secondary outcomes (3)
Correlation of HbA1C, t-PA, CRP, IL-6, HOMA-IR and ICAM-1 with change in carotid IMT in metformin- and placebo-treated groups will be evaluated.
Measured: 1.5 years
Difference in progression of carotid total plaque area (measured in square millimetres) between groups treated with metformin and placebo
Measured: 1.5 years
Difference in progression of carotid total plaque volume (measured in cubic millimetres) between groups treated with metformin and placebo
Measured: 1.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2008 (estimated)
- Study startFeb 2009
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 173 participants (actual)
Sponsor and investigators
- Lead sponsor
- Professor Naveed Sattar
- Sponsor type
- University, hospital or other
- Collaborators
- NHS Greater Glasgow and Clyde, Chief Scientist Office of the Scottish Government
- Responsible party
- Sponsor-investigator, Professor Naveed Sattar, University of Glasgow
- Investigators
- Naveed Sattar, PhD, Principal investigator, University of Glasgow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00723307
- Sponsor's protocol ID
- Gla-Met-1 (version 5)
- Acronym
- CAMERA
- Status last verified
- Dec 2012
- First submitted
- 24 Jul 2008
- Last updated
- 11 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Preiss D, Welsh P, Sattar N. Metformin Therapy and Circulating NT-proBNP Levels: The CAMERA Trial. Diabetes Care. 2016 Aug;39(8):e114-5. doi: 10.2337/dc16-0887. Epub 2016 Jun 6. No abstract available.
PubMed 27271181Preiss D, Lloyd SM, Ford I, McMurray JJ, Holman RR, Welsh P, Fisher M, Packard CJ, Sattar N. Metformin for non-diabetic patients with coronary heart disease (the CAMERA study): a randomised controlled trial. Lancet Diabetes Endocrinol. 2014 Feb;2(2):116-24. doi: 10.1016/S2213-8587(13)70152-9. Epub 2013 Nov 7.
PubMed 24622715
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Placebo-controlled Trial of Metformin on Progression of Carotid Atherosclerosis in Non-diabetic Patients With Cardiovascular Disease Treated With Conventional Risk Reducing Agents
- ClinicalTrials.gov ID
- NCT00723307
- Acronym / sponsor ID
- CAMERA / Gla-Met-1 (version 5)
- Conditions
- Coronary Artery Disease
- Keywords
- No diabetes mellitus, Elevated waist circumference
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 173 participants (actual)
- Lead sponsor
- Professor Naveed SattarUniversity, hospital or other
- Collaborators
- NHS Greater Glasgow and Clyde, Chief Scientist Office of the Scottish Government
- Study start
- Feb 2009
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 28 Jul 2008 (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.
Hypothesis: Treatment with metformin in overweight non-diabetic individuals with coronary heart disease and on standard cardiovascular risk reducing agents including statins will have a beneficial impact on carotid artery atherosclerosis compared to placebo.
Rationale: Once subjects have a heart attack, they remain at much higher than average risk of another heart attack and stroke, despite the best current therapies to lower their cholesterol and blood pressure and thin their blood. Many subjects with heart disease also have problems metabolising (i.e. processing) sugar even if they do not have diabetes. There is some evidence that metformin, a drug which improves sugar metabolism, decreases the risk of future heart attacks in diabetic patients. However, whether metformin further reduces the risk of heart disease beyond established treatments in people without diabetes is unknown.
Method: The investigators will test the ability metformin, a drug with proven safety, to slow the progression of furring up (known as atherosclerosis) of blood vessels in non-diabetic subjects with heart disease. This will be achieved by treating 2 groups of subjects with metformin and placebo pills respectively. To measure atherosclerosis, the investigators will carry out ultrasound scans of the big blood vessels in the neck at the start of the study, after 1 year and after 1.5 years of therapy.The investigators will then be able to assess whether metformin has had a beneficial impact.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Metformin | Experimental | Drug: Metformin |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Proven coronary heart disease (prior acute coronary syndrome, prior CABG or angiographically proven CHD)
- Aged 35-75 years
- Elevated waist circumference as per the International Diabetes Foundation criteria (94 cm in men and 80 cm in women)
- All patients will be on statin
Key exclusion criteria (8 listed)
- Pregnancy and/or lactation at screening
- Premenopausal woman not on contraception
- Known or newly diagnosed diabetes mellitus on oral glucose tolerance testing (OGTT will be performed on subjects with HbA1C 6.0-6.9% and fasting plasma glucose [FPG] < 7.0 mmol/L at screening18)
- Screening results: HbA1C ≥ 7.0% and/or fasting plasma glucose ≥ 7.0 mmol/L
- Patients with Acute Coronary Syndrome within the last 3 months
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 |
|---|---|---|
| MetforminAlso: Glucophage, Glucophage SR, Bolamyn SRWhite film-coated tablets, 850mg tablet twice daily, 1.5 years duration | Drug | Metformin |
| PlaceboAlso: Dummy pillWhite coated tablet; one tablet twice daily; 1.5 years duration | Drug | Placebo |
Primary outcome
Difference in progression of carotid intima-media thickness (measured in millimetres) between groups treated with metformin and placebo
Time frame: 1.5 years
3 secondary outcomes
Correlation of HbA1C, t-PA, CRP, IL-6, HOMA-IR and ICAM-1 with change in carotid IMT in metformin- and placebo-treated groups will be evaluated.
Time frame: 1.5 years
Difference in progression of carotid total plaque area (measured in square millimetres) between groups treated with metformin and placebo
Time frame: 1.5 years
Difference in progression of carotid total plaque volume (measured in cubic millimetres) between groups treated with metformin and placebo
Time frame: 1.5 years
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 11 Dec 2012.
- Derived from this study: PubMed 27271181Preiss D, Welsh P, Sattar N. Metformin Therapy and Circulating NT-proBNP Levels: The CAMERA Trial. Diabetes Care. 2016 Aug;39(8):e114-5. doi: 10.2337/dc16-0887. Epub 2016 Jun 6. No abstract available.
- Derived from this study: PubMed 24622715Preiss D, Lloyd SM, Ford I, McMurray JJ, Holman RR, Welsh P, Fisher M, Packard CJ, Sattar N. Metformin for non-diabetic patients with coronary heart disease (the CAMERA study): a randomised controlled trial. Lancet Diabetes Endocrinol. 2014 Feb;2(2):116-24. doi: 10.1016/S2213-8587(13)70152-9. Epub 2013 Nov 7.
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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, PhD 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 Metformin in people with Coronary Artery Disease, run by Professor Naveed Sattar 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 4 inclusion and 8 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 11 Dec 2012. 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. Some participants in this study may receive a placebo. 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?
Difference in progression of carotid intima-media thickness (measured in millimetres) between groups treated with metformin and placebo (time frame: 1.5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00723307, which also lists 2 linked publications.
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 11 Dec 2012.