Diabetes Mellitus Type 2 (T2DM)Phase 3Lina-PlaqueNCT02077309
Effect of Linagliptin on Vascular Inflammation in Patients With Type 2 Diabetes Mellitus
A Phase 3 study testing Linagliptin in people with Diabetes Mellitus Type 2 (T2DM) and Vascular Inflammation, run by RWTH Aachen University at 2 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Diabetes Mellitus Type 2 (T2DM), Vascular Inflammation, Plaque Morphology
- What is being tested?
- Linagliptin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 4 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Aug 2014to Nov 2015
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Show all 19Show fewer
- 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
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Germany1 site
Department of Internal Medicine I, University Hospital
Aachen, 52074
Netherlands1 site
Cardiovascular Research Institute Maastricht (CARIM)
Maastricht, 6229
About this study
Official title: Linagliptin as a Modulator of Vascular Inflammation in Patients With Type 2 Diabetes Mellitus
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.
Read the 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.
- Being tested
- Linagliptin, Placebo
- Keywords
- T2DM,, vascular inflammation,, 18-FDG-PET,, plaque morphology,, MRI,, DPP-4 Inhibition
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LinagliptinDrug
Also called Trade name Trajenta® by Boehringer Ingelheim (BI) Pharma GmbH & Co KG, Biberach, Germany
PlaceboDrug
Also called Produced by Boehringer Ingelheim (BI) Pharma GmbH & Co KG, Biberach, Germany
| Study group | Role | What they receive |
|---|---|---|
| Linagliptin | Active comparator | Patients will receive 5 mg linagliptin once daily for a period of 6 months. Receives: Drug: Linagliptin |
| Placebo | Placebo comparator | Patients will take placebo tablets once daily for a period of 6 months. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 6 months
Secondary outcomes (3)
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.
Measured: baseline and 6 months
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.
Measured: baseline and 6 months
Effect of linagliptin on biomarkers of vascular inflammation
Blood analysis to examine the effect of linagliptin on biomarkers of vascular inflammation.
Measured: baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2014 (estimated)
- Study startAug 2014
- Primary completionSep 2015
- Study completionNov 2015
Why it stopped: bad recruitment of suitable participants, just 4 patients in one year
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus Type 2 (T2DM)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- RWTH Aachen University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nikolaus Marx, Univ.-Prof., Principal investigator, Department of Internal Medicine I, RWTH Aachen University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02077309
- Sponsor's protocol ID
- 12-027
- Other IDs
- 111/13, 2012-003859-12
- Acronym
- Lina-Plaque
- Status last verified
- Dec 2015
- First submitted
- 28 Feb 2014
- Last updated
- 12 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Linagliptin as a Modulator of Vascular Inflammation in Patients With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT02077309
- Acronym / sponsor ID
- Lina-Plaque / 12-027
- Keywords
- T2DM,, vascular inflammation,, 18-FDG-PET,, plaque morphology,, MRI,, DPP-4 Inhibition
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: bad recruitment of suitable participants, just 4 patients in one year
- Enrolment
- 4 participants (actual)
- Lead sponsor
- RWTH Aachen UniversityUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Sep 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 4 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Linagliptin | Active comparator | Drug: LinagliptinPatients will receive 5 mg linagliptin once daily for a period of 6 months. |
| Placebo | Placebo comparator | Drug: PlaceboPatients will take placebo tablets once daily for a period of 6 months. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LinagliptinAlso: Trade name Trajenta® by Boehringer Ingelheim (BI) Pharma GmbH & Co KG, Biberach, Germany | Drug | Linagliptin |
| PlaceboAlso: Produced by Boehringer Ingelheim (BI) Pharma GmbH & Co KG, Biberach, Germany | Drug | Placebo |
Primary outcome
Effect of linagliptin on vascular inflammation of the carotic artery
Time frame: up to 6 months
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.
3 secondary outcomes
Effect of linagliptin on vessel wall volume of the carotid artery
Time frame: baseline and 6 months
Effect of linagliptin on abdominal adipose tissue inflammation
Time frame: baseline and 6 months
Effect of linagliptin on biomarkers of vascular inflammation
Time frame: baseline and 6 months
Results and safety
The study was stopped early (reason given: bad recruitment of suitable participants, just 4 patients in one year). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2017.
Related trials for Diabetes Mellitus Type 2 (T2DM)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 2
A Phase 2 Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of SAL0150 Tablets in Subjects With Type 2 Diabetes Mellitus
Type 2 Diabetes Mellitus (T2DM), Type 2 Diabetes
RecruitingPhase 3
A Study to Evaluate the Effects of Enicepatide in Participants With Obesity or Overweight, With or Without Type 2 Diabetes
Obesity, Overweight
RecruitingObservational study
Chiglitazar Added to SGLT-2 Inhibitors for Type 2 Diabetes
T2DM (Type 2 Diabetes Mellitus)
Active, not recruitingObservational study
An Observational Study to Learn More About How Safe Finerenone is and How Well it Works in Indian People With Chronic Kidney Disease and Type 2 Diabetes in Routine Medical Practice
Chronic Kidney Disease, Type 2 Diabetes Mellitus
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nikolaus Marx, Univ.-Prof. principal investigator
Department of Internal Medicine I, RWTH Aachen University Hospital
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Linagliptin in people with Diabetes Mellitus Type 2 (T2DM) and Vascular Inflammation, run by RWTH Aachen University at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 12 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: bad recruitment of suitable participants, just 4 patients in one year). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of linagliptin on vascular inflammation of the carotic artery (time frame: up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2017.