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Carotid Atherosclerosis: MEtformin for Insulin ResistAnce Study (CAMERA)

This study has been completed.
Sponsor:
Collaborators:
NHS Greater Glasgow and Clyde
Chief Scientist Office of the Scottish Government
Information provided by (Responsible Party):
Professor Naveed Sattar, University of Glasgow
ClinicalTrials.gov Identifier:
NCT00723307
First received: July 24, 2008
Last updated: December 7, 2012
Last verified: December 2012

July 24, 2008
December 7, 2012
February 2009
December 2012   (final data collection date for 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 ] [ Designated as safety issue: No ]
Difference in progression of carotid intima-media thickness (measured in millimetres) between groups treated with metformin and placebo [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00723307 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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: 2 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: 2 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: 2 years ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Carotid Atherosclerosis: MEtformin for Insulin ResistAnce Study
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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Coronary Artery Disease
  • 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 Name: Dummy pill
  • Experimental: Metformin
    Intervention: Drug: Metformin
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Preiss 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
173
December 2012
December 2012   (final data collection date for primary outcome measure)

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
Both
35 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00723307
Gla-Met-1 (version 5)
No
Professor Naveed Sattar, University of Glasgow
Professor Naveed Sattar
  • NHS Greater Glasgow and Clyde
  • Chief Scientist Office of the Scottish Government
Principal Investigator: Naveed Sattar, PhD University of Glasgow
University of Glasgow
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP