Effect of Linagliptin on Vascular Inflammation in Patients With Type 2 Diabetes Mellitus

Vascular Inflammation Clinical Trial

— Lina-Plaque  

Official title:

Linagliptin as a Modulator of Vascular Inflammation in Patients With Type 2 Diabetes Mellitus

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02077309
• Other study ID #: 12-027
• Secondary ID: 111/132012-00385
• Status: Terminated
• Phase: Phase 3
• First received: February 28, 2014
• Last updated: April 10, 2017
• Start date: August 2014
• Est. completion date: November 2015

Study information

• Verified date: December 2015
• Source: RWTH Aachen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Examination of the effect of Linagliptin versus placebo for 6 months on vascular inflammation of the carotic artery and on abdominal adipose tissue inflammation in patients with diabetes mellitus type 2. The effect will be assessed by FDG-PET scan.

Furthermore the effect of Linagliptin on the vessel wall volume of the carotid artery will be assessed by MRI scan and biomarkers of vascular inflammation will be analyzed in blood samples.

Description:

As part of the screening a PET-CT scan is executed to examine baseline vascular inflammation of the carotid artery and to evaluate abdominal adipose tissues inflammation.

Patients who are eligible to participate in the study according to the in- and exclusion criteria will be randomised in one of the two study arms.

According to the randomisation the patients will receive 5 mg Linagliptin or placebo per day for a period of 6 months.

To evaluate the effect of Linagliptin versus placebo the vessel wall volume of the artery will be assessed by MRI scan and the vascular inflammation of the carotid artery by FDG-PET, furthermore the vascular inflammation will be analyzed by biomarkers in blood samples and the abdominal adipose tissue inflammation will investigated by subcutaneous adipose tissue biopsies.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: November 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

1. Diabetes mellitus Type 2

2. HbA1c > 7%

3. Age > 50 years

4. Coronary artery disease or carotid artery disease

5. 18F-FDG uptake of the carotid arterial wall to background (blood) ratio > 1.8

6. Written informed consent prior to study participation

7. Stable anti-diabetic and cholesterol lowering medication for the last 3 month

8. 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);

9. Indication to increase anti-diabetic medication as judged by the investigator

Exclusion Criteria:

1. Diabetes mellitus type 1

2. Use of DPP-4 Inhibitor, GLP-1 agonists, Thiazolindinedione

3. Kidney disease CKD 4 and more (GFR < 30 ml/min/1.73)

4. Liver disease (ALT or AST > 3 times the upper limit of norm) or known liver cirrhosis

5. Any reason for not being able to sustain the imaging studies

6. Pacemaker/ICD/metallic clips in close relation to vessels in the brain

7. Uncontrolled thyroid disease

8. Active malignant disease

9. Chronic inflammatory disease

10. Chronic use of NSAR or cortison

11. HbA1c > 8.5%

12. Recent (<3 months) clinically significant coronary or cerebral vascular event

13. Pregnant females as determined by positive [serum or urine] HCG test at Screening or prior to dosing

14. Lactating females

15. 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

16. The subject received an investigational drug within 30 days prior to inclusion into this study

17. 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

18. The subject is unwilling or unable to follow the procedures outlined in the protocol

19. The subject is mentally or legally incapacitated

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus Type 2 (T2DM)
• Diabetes Mellitus, Type 2
• Inflammation
• Plaque Morphology
• Vascular Inflammation

Intervention

Drug:
• Linagliptin

• Placebo

Locations

Country	Name	City	State
Germany	Department of Internal Medicine I, University Hospital	Aachen
Netherlands	Cardiovascular Research Institute Maastricht (CARIM)	Maastricht

Sponsors (1)

Lead Sponsor	Collaborator
RWTH Aachen University

Countries where clinical trial is conducted

Germany,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect of linagliptin on vascular inflammation of the carotic artery	Examination of the effect of 5 mg linagliptin qd versus placebo on vascular inflammation of the carotic artery by FDG-PET in patients with diabetes mellitus within 6 months.	up to 6 months
Secondary	Effect of linagliptin on vessel wall volume of the carotid artery	Examination of the effect of 5mg linagliptin qd versus placebo on vessel wall volume of the carotid artery by MRI scan.	baseline and 6 months
Secondary	Effect of linagliptin on abdominal adipose tissue inflammation	Evaluation of the effect of 5mg linagliptin qd versus placebo on abdominal adipose tissue inflammation by FDG-PET in addition to adipose tissue biopsies.	baseline and 6 months
Secondary	Effect of linagliptin on biomarkers of vascular inflammation	Blood analysis to examine the effect of linagliptin on biomarkers of vascular inflammation.	baseline and 6 months