Carotid Atherosclerosis: MEtformin for Insulin ResistAnce Study | RxWiki

Carotid Atherosclerosis: MEtformin for Insulin ResistAnce Study

Overview[ - collapse ][ - ]

Purpose	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.
Condition	Coronary Artery Disease
Intervention	Drug: Metformin Drug: Placebo
Phase	Phase 4
Sponsor	Professor Naveed Sattar
Responsible Party	University of Glasgow
ClinicalTrials.gov Identifier	NCT00723307
First Received	July 24, 2008
Last Updated	December 7, 2012
Last verified	December 2012

Tracking Information[ + expand ][ + ]

First Received Date	July 24, 2008
Last Updated Date	December 7, 2012
Start Date	February 2009
Estimated Primary Completion Date	December 2012
Current Primary Outcome Measures	Difference in progression of carotid intima-media thickness (measured in millimetres) between groups treated with metformin and placebo [Time Frame: 1.5 years] [Designated as safety issue: No]
Current Secondary Outcome Measures	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] [Designated as safety issue: No] Difference in progression of carotid total plaque area (measured in square millimetres) between groups treated with metformin and placebo [Time Frame: 1.5 years] [Designated as safety issue: No] Difference in progression of carotid total plaque volume (measured in cubic millimetres) between groups treated with metformin and placebo [Time Frame: 1.5 years] [Designated as safety issue: No]

Descriptive Information[ + expand ][ + ]

Brief Title	Carotid Atherosclerosis: MEtformin for Insulin ResistAnce 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
Brief 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. 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.
Detailed Description	Not Provided
Study Type	Interventional
Study Phase	Phase 4
Study Design	Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Condition	Coronary Artery Disease
Intervention	Drug: Metformin White film-coated tablets, 850mg tablet twice daily, 1.5 years duration Other Names: Glucophage Glucophage SR Bolamyn SR Drug: Placebo White coated tablet; one tablet twice daily; 1.5 years duration Other Names: Dummy pill
Study Arm (s)	Experimental: Metformin Placebo Comparator: Placebo

Recruitment Information[ + expand ][ + ]

Recruitment Status	Completed
Estimated Enrollment	173
Estimated Completion Date	December 2012
Estimated Primary Completion Date	December 2012
Eligibility Criteria	Inclusion Criteria: - 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 Exclusion Criteria: - 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
Gender	Both
Ages	35 Years
Accepts Healthy Volunteers	No
Contacts	Not Provided
Location Countries	United Kingdom

Administrative Information[ + expand ][ + ]

NCT Number	NCT00723307
Other Study ID Numbers	Gla-Met-1 (version 5)
Has Data Monitoring Committee	No
Information Provided By	University of Glasgow
Study Sponsor	Professor Naveed Sattar
Collaborators	NHS Greater Glasgow and Clyde Chief Scientist Office of the Scottish Government
Investigators	Principal Investigator: Naveed Sattar, PhD University of Glasgow
Verification Date	December 2012

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