Back to resultsEffect of Linagliptin on Vascular Inflammation in Patients With Type 2 Diabetes Mellitus (Lina-Plaque)
Primary Purpose
Diabetes Mellitus Type 2 (T2DM), Vascular Inflammation, Plaque Morphology
Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Linagliptin
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus Type 2 (T2DM) focused on measuring T2DM,, vascular inflammation,, 18-FDG-PET,, plaque morphology,, MRI,, DPP-4 Inhibition
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 anti-diabetic and 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
Exclusion Criteria:
- Diabetes mellitus type 1
- Use of DPP-4 Inhibitor, GLP-1 agonists, Thiazolindinedione
- Kidney disease CKD 4 and more (GFR < 30 ml/min/1.73)
- Liver disease (ALT or AST > 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
- Chronic inflammatory disease
- Chronic use of NSAR or cortison
- HbA1c > 8.5%
- Recent (<3 months) clinically significant coronary or cerebral vascular event
- 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
Sites / Locations
- Department of Internal Medicine I, University Hospital
- Cardiovascular Research Institute Maastricht (CARIM)
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Linagliptin
Placebo
Arm Description
Patients will receive 5 mg linagliptin once daily for a period of 6 months.
Patients will take placebo tablets once daily for a period of 6 months.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
Effect of linagliptin on biomarkers of vascular inflammation
Blood analysis to examine the effect of linagliptin on biomarkers of vascular inflammation.
Full Information
NCT ID
NCT02077309
First Posted
February 28, 2014
Last Updated
April 10, 2017
Sponsor
RWTH Aachen University
1. Study Identification
Unique Protocol Identification Number
NCT02077309
Brief Title
Effect of Linagliptin on Vascular Inflammation in Patients With Type 2 Diabetes Mellitus
Acronym
Lina-Plaque
Official Title
Linagliptin as a Modulator of Vascular Inflammation in Patients With Type 2 Diabetes Mellitus
Study Type
Interventional
2. Study Status
Record Verification Date
December 2015
Overall Recruitment Status
Terminated
Why Stopped
bad recruitment of suitable participants, just 4 patients in one year
Study Start Date
August 2014 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
November 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
RWTH Aachen University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus Type 2 (T2DM), Vascular Inflammation, Plaque Morphology
Keywords
T2DM,, vascular inflammation,, 18-FDG-PET,, plaque morphology,, MRI,, DPP-4 Inhibition
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
4 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Linagliptin
Arm Type
Active Comparator
Arm Description
Patients will receive 5 mg linagliptin once daily for a period of 6 months.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Patients will take placebo tablets once daily for a period of 6 months.
Intervention Type
Drug
Intervention Name(s)
Linagliptin
Other Intervention Name(s)
Trade name Trajenta® by Boehringer Ingelheim (BI) Pharma GmbH & Co KG, Biberach, Germany
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Produced by Boehringer Ingelheim (BI) Pharma GmbH & Co KG, Biberach, Germany
Primary Outcome Measure Information:
Title
Effect of linagliptin on vascular inflammation of the carotic artery
Description
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.
Time Frame
up to 6 months
Secondary Outcome Measure Information:
Title
Effect of linagliptin on vessel wall volume of the carotid artery
Description
Examination of the effect of 5mg linagliptin qd versus placebo on vessel wall volume of the carotid artery by MRI scan.
Time Frame
baseline and 6 months
Title
Effect of linagliptin on abdominal adipose tissue inflammation
Description
Evaluation of the effect of 5mg linagliptin qd versus placebo on abdominal adipose tissue inflammation by FDG-PET in addition to adipose tissue biopsies.
Time Frame
baseline and 6 months
Title
Effect of linagliptin on biomarkers of vascular inflammation
Description
Blood analysis to examine the effect of linagliptin on biomarkers of vascular inflammation.
Time Frame
baseline and 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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 anti-diabetic and 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
Exclusion Criteria:
Diabetes mellitus type 1
Use of DPP-4 Inhibitor, GLP-1 agonists, Thiazolindinedione
Kidney disease CKD 4 and more (GFR < 30 ml/min/1.73)
Liver disease (ALT or AST > 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
Chronic inflammatory disease
Chronic use of NSAR or cortison
HbA1c > 8.5%
Recent (<3 months) clinically significant coronary or cerebral vascular event
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nikolaus Marx, Univ.-Prof.
Organizational Affiliation
Department of Internal Medicine I, RWTH Aachen University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Internal Medicine I, University Hospital
City
Aachen
ZIP/Postal Code
52074
Country
Germany
Facility Name
Cardiovascular Research Institute Maastricht (CARIM)
City
Maastricht
ZIP/Postal Code
6229
Country
Netherlands
12. IPD Sharing Statement
Learn more about this trial
Effect of Linagliptin on Vascular Inflammation in Patients With Type 2 Diabetes Mellitus
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