patients with type 2 diabetes mellitus and vascular inflammation MedDRA version: 17.0 Level: PT Classification code 10061218 Term: Inflammation System Organ Class: 10018065 - General disorders and administration site conditions MedDRA version: 17.0 Level: PT Classification code 10012601 Term: Diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders
Conditions
Interventions
Trade Name: Trajenta 5 mg Filmtabletten
Product Name: Trajenta 5 mg coated tablets
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Linagliptin
CAS Number: 668270-12-0
Concentration unit:
Sponsors
RWTH Aachen University for the Medical Faculty, represented by Clinical Trial Center Aachen (CTC-A)
Eligibility
Sex/Gender
All
Inclusion 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 Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 40
Exclusion criteria
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% - Patients with a history of pancreatitis - Recent (< 6 weeks) clinically significant coronary or cerebral vascular event - Indication for coronary artery or cerebral vascular intervention in the next 6 month - Pregnant females as determined by positive [serum or urine] hCG test at Screening or prior to dosing - Lactating females - The subject has a history of any other illness, which, in the opinion of the Investigator, might pose an unacceptable risk by administering study medication. - The subject received an investigational drug within 30 days prior to inclusion into this study - The subject has any current or past medical condition and/or required medication to treat a condition that could affect the evaluation of the study - The subject is unwilling or unable to follow the procedures outlined in the protocol - The subject is mentally or legally incapacitated
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Main objective of the present study is to examine the preventative effect of linagliptin 5 mg qd versus placebo on vascular inflammation of the carotic artery by FDG-PET in patients with type 2 diabetes mellitus;Secondary Objective: Secondary objectives of the present study are to examine the preventative effect of linagliptin 5 mg qd versus placebo on vessel wall volume of the carotic artery by MRI scan and biomarkers of vascular inflammation.;Primary end point(s): Effect of linagliptin on 18F-fluorodeoxyglucose (FDG) uptake of the carotid arterial wall by positron emission tomography (PET) as depicted by the target-to-background ratio after 6 month of treatment.;Timepoint(s) of evaluation of this end point: 6 month | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Effect of linagliptin on magnetic resonance imaging (MRI) plaque burden specified as: - wall area - wall thickness - total vessel area - wall area/total vessel area ratio - plaque morphology (fibrous cap status, presence of ulcerations, necrotic core volume) - plaque perfusion based on the average of the right and left carotids after 6 month of treatment • Effects of linagliptin on vascular biomarker (high-sensitivity C-reactive protein, interleukin-6, soluble platelet-selectin, soluble E-selectin, soluble intercellular adhesion molecule, vascular cell adhesion molecule (VCAM), endothelin-1, phospholipase A2 (PLA2), matrix metalloproteinase (MMP)-3, MMP-9, adiponectin, myeloperoxidase (MPO), tissue plasminogen activator (TPA), plasminogen activator inhibitor-1 (PAI-1), total GLP-1, active GLP-1 after 3 and 6 month of treatment. • Effects of linagliptin on adipose tissue inflammation by 18F-fluorodeoxyglucose (FDG) uptake to the subcutaneous and visceral adipose tissue in addition to expression of inflammatory biomarkers (CD3, CD68, TNFa, IFNg, MCP-1, Adiponectin) in subcutaneous adipose tissue biopsies. ;Timepoint(s) of evaluation of this end point: after 3 and 6 months of treatment | — |
Countries
Germany, Netherlands
Contacts
Public ContactClinical Trial Center
Clinical Trial Center Aachen (CTC-A)
Outcome results
None listed