NCT02077309

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.

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Aug 2014

Shorter than P25 for phase_3

Geographic Reach
2 countries

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 28, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 4, 2014

Completed
5 months until next milestone

Study Start

First participant enrolled

August 1, 2014

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
Last Updated

April 12, 2017

Status Verified

December 1, 2015

Enrollment Period

1.1 years

First QC Date

February 28, 2014

Last Update Submit

April 10, 2017

Conditions

Diabetes Mellitus Type 2 (T2DM)Vascular InflammationPlaque Morphology

Keywords

T2DM,vascular inflammation,18-FDG-PET,plaque morphology,MRI,DPP-4 Inhibition

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Effect of linagliptin on vessel wall volume of the carotid artery

    baseline and 6 months

  • Effect of linagliptin on abdominal adipose tissue inflammation

    baseline and 6 months

  • Effect of linagliptin on biomarkers of vascular inflammation

    baseline and 6 months

Study Arms (2)

Linagliptin

ACTIVE COMPARATOR

Patients will receive 5 mg linagliptin once daily for a period of 6 months.

Drug: Linagliptin

Placebo

PLACEBO COMPARATOR

Patients will take placebo tablets once daily for a period of 6 months.

Drug: Placebo

Interventions

LinagliptinDRUG
Also known as: Trade name Trajenta® by Boehringer Ingelheim (BI) Pharma GmbH & Co KG, Biberach, Germany
Linagliptin
PlaceboDRUG
Also known as: Produced by Boehringer Ingelheim (BI) Pharma GmbH & Co KG, Biberach, Germany
Placebo

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diabetes mellitus Type 2
  • HbA1c \> 7%
  • Age \> 50 years
  • Coronary artery disease or carotid artery disease
  • F-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

You may not qualify if:

  • 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
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Department of Internal Medicine I, University Hospital

Aachen, 52074, Germany

Location

Cardiovascular Research Institute Maastricht (CARIM)

Maastricht, 6229, Netherlands

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Linagliptin

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

PurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsQuinazolines

Study Officials

  • Nikolaus Marx, Univ.-Prof.

    Department of Internal Medicine I, RWTH Aachen University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 28, 2014

First Posted

March 4, 2014

Study Start

August 1, 2014

Primary Completion

September 1, 2015

Study Completion

November 1, 2015

Last Updated

April 12, 2017

Record last verified: 2015-12

Locations

NL(1)DE(1)