EUCTR2012-003859-12-DE
Active, not recruiting
Not Applicable
inagliptin as a modulator of vascular inflammation in patients with type 2 diabetes mellitus - Lina-Plaque
RWTH Aachen University for the Medical Faculty, represented by Clinical Trial Center Aachen (CTC-A)0 sites60 target enrollmentApril 22, 2013
Conditionspatients with type 2 diabetes mellitus and vascular inflammationMedDRA version: 17.0Level: PTClassification code 10061218Term: InflammationSystem Organ Class: 10018065 - General disorders and administration site conditionsMedDRA version: 17.0Level: PTClassification code 10012601Term: Diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disordersTherapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- patients with type 2 diabetes mellitus and vascular inflammation
- Sponsor
- RWTH Aachen University for the Medical Faculty, represented by Clinical Trial Center Aachen (CTC-A)
- Enrollment
- 60
- Status
- Active, not recruiting
- Last Updated
- 10 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\- Diabetes mellitus Type 2
- •\- HbA1c \> 7%
- •\- Age \> 50 years
- •\- Coronary artery disease or carotid artery disease
- •\- 18F\-FDG uptake of the carotid arterial wall to background (blood) ratio \> 1\.8
- •\- Written informed consent prior to study participation
- •\- Stable cholesterol lowering medication for the last 3 month
- •\- Stable anti\-diabetic medication for the last 6 weeks which should include a maximal tolerated dose of metformin (unless contraindication or intolerance to metformin does exist)
- •\- Indication to increase anti\-diabetic medication as judged by the investigator
- •Are the trial subjects under 18? no
Exclusion Criteria
- •\- Diabetes mellitus type 1
- •\- Use of DPP\-4 Inhibitor and GLP\-1 agonists
- •\- Liver disease (GPT or GOT \> 3 times the upper limit of norm) or known liver cirrhosis
- •\- Any reason for not being able to sustain the imaging studies
- •\- Pacemaker/ICD/metallic clips in close relation to vessels in the brain
- •\- Uncontrolled thyroid disease
- •\- Active malignant disease of any kind with the exception of basalioma
- •\- Chronic inflammatory disease
- •\- Chronic use of NSAR or cortisone
- •\- HbA1c \> 10%
Outcomes
Primary Outcomes
Not specified
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