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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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12 December 2020 |
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Main ID: |
NCT02350478 |
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Date of registration:
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26/01/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Effects of Linagliptin on Endothelial Function
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Scientific title:
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Effects of Linagliptin on Endothelial Function and Global Arginine Bioavailability Ratio in Coronary Artery Disease Patients With Early Diabetes |
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Date of first enrolment:
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July 2013 |
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Target sample size:
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49 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02350478 |
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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. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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Phase 4
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Countries of recruitment
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Austria
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Contacts
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Name:
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Harald Sourij, Assoc.-Prof. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Medical University of Graz |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Age: 40 to 80 years
- Early diabetes (postchallenge diabetes (2h glucose >200 mg/dl or type 2 diabetes
treated with diet only or on a stable dose of metformin monotherapy)
- Coronary atherosclerosis (diagnosed via coronary angiography or coronary computer
tomography)
Exclusion Criteria:
- Acute coronary syndrome or cerebrovascular event within the previous 4 weeks
- Body Mass Index (BMI) > 35 kg/m2
- HbA1c <6.0% (42 mmol/mol)
- Serum creatinine > 2.5 mg/dl
- Aspartate Transaminase (AST)/Alanine Transaminase (ALT)>3x upper limit of normal
- HbA1c >9.0% (>75 mmol/mol)
- Heart failure > New York Heart Association (NYHA) class II
- Uncontrolled hypertension (blood pressure > 165 / 100 mmHg)
- Treatment with orally administered steroids
- New onset statin or Angiotensin Converting Enzym- (ACE-) inhibitor within the previous
6 weeks
- Known Malignancy
- Pregnancy or breast feeding women.
Age minimum:
40 Years
Age maximum:
80 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Coronary Artery Disease
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Type 2 Diabetes
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Intervention(s)
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Drug: Linagliptin
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Drug: Placebo
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Primary Outcome(s)
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Changes in Endothelial Function (FMD - Flow Mediated Dilatation) From Baseline to 12 Weeks
[Time Frame: 12 weeks]
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Secondary Outcome(s)
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Changes in the Area Under Curve (AUC) of Free Fatty Acids During the Meal Tolerance Test From Baseline to 12 Weeks
[Time Frame: 12 weeks]
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Changes in Biochemical Markers (sICAM-1)
[Time Frame: 12 weeks]
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Changes in the Area Under Curve (AUC) of Glucose, Insulin and C-peptide During the Meal Tolerance Test From Baseline to 12 Weeks
[Time Frame: 12 weeks]
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Changes in Biochemical Markers (svCAM-1)
[Time Frame: 12 weeks]
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Changes in Global Arginine Bioavailability Ratio (Ratio of Arginine to [Ornithine + Citrulline]) and Arginine to Ornithine Ratio From Baseline to 12 Weeks
[Time Frame: 12 weeks]
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Secondary ID(s)
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HS-2012-01
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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