Effect of Linagliptin on vascular inflammation in patients with type 2 diabetes mellitus

• Conditions: patients with type 2 diabetes mellitus and vascular inflammation; MedDRA version: 17.0Level: PTClassification code 10061218Term: InflammationSystem Organ Class: 10018065 - General disorders and administration site conditions; MedDRA version: 17.0Level: PTClassification code 10012601Term: Diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2012-003859-12-DE
• Lead Sponsor: RWTH Aachen University for the Medical Faculty, represented by Clinical Trial Center Aachen (CTC-A)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-04-22
• Last Update Posted: 7 December 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 60

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

- 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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