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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT01552018 |
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Date of registration:
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22/02/2012 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Saxagliptin and Atherosclerosis
SAXATH |
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Scientific title:
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Saxagliptin and Atherosclerosis. A Possible Role for Saxagliptin in the Prevention of Atherosclerosis Beyond Glucose Metabolism. |
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Date of first enrolment:
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March 2012 |
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Target sample size:
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12 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01552018 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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Phase:
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Phase 4
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Countries of recruitment
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Norway
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Contacts
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Name:
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Ida U Njerve, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Center for Clinical Heart Research, Dept. of Cardiology, Oslo University Hospital Ullevaal, Norway |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Patients > 18, < 80 years old, with type 2 diabetes mellitus and angiographically
proven coronary artery disease.
- HbA1c > 6.5% and under treatment with either metformin and/or glimepiride.
Exclusion Criteria:
- Allergy or hypersensitivity to any of the drug's components.
- Heart failure in NYHA class III or IV.
- Severe liver failure, moderate or severe kidney failure
- Malignant disease.
- Active infectious disease.
- Acute coronary syndrome in the last 3 months.
- Pregnancy or breastfeeding.
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Diabetes Mellitus Type 2
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Coronary Artery Disease
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Intervention(s)
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Drug: Placebo
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Drug: Saxagliptin
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Primary Outcome(s)
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Inflammatory biomarkers
[Time Frame: Changes in biomarkers from baseline to 3 months]
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Secondary Outcome(s)
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Gene expression of DPP-4 in adipose tissue and leukocytes
[Time Frame: Change in expression level of DPP-4 from baseline to 3 months]
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Secondary ID(s)
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2011/773b (REK)
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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