The impact on the blood sugar lowering drug Linagliptin and blood vessel function in patients with type 2 diabetes

Effects of Linagliptin on endothelial function and global arginine bioavailability ratio in coronary artery disease patients with early diabetes - Linagliptin and endothelial function

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-000330-35-AT

Enrollment

Registered

2013-04-23

Start date

2013-05-23

Completion date

Unknown

Last updated

2018-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes mellitus Type 2 MedDRA version: 14.1 Level: PT Classification code 10067585 Term: Type 2 diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders

Interventions

Trade Name: Trajenta (Linagliptin) Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Linagliptin CAS Number: 668270-12-0 Current Sponsor code: EU/1/11/707 Other descriptive name: LINAGLIPTI

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Age 40-75 - Early diabetes (postchallenge diabetes (2h glucose >200 mg/dl or type 2 diabetes treated with diet only or on a stable dose of metformin monotherapy) - Coronary atherosclerosis (diagnosed via coronary angiography or coronary computer tomography) 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 35 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 15

Exclusion criteria

Exclusion criteria: - Acute coronary syndrome or cerebrovascular event within the previous 4 weeks -BMI > 35 kg/m2 - Serum creatinine > 2.5 mg/dl - AST/ALT > 3x upper limit of normal - HbA1c >9.0% (>75 mmol/mol) - Heart failure > NYHA class II - Uncontrolled hypertension (blood pressure > 165 / 100 mmHg) - Treatment with orally administered steroids - New onset statin or ACE-inhibitor within the previous 6 weeks - Known Malignancy - Pregnancy or breast feeding women.

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective is to investigate the impact of a 12 week linagliptin treatment on endothelial function in patients with early type 2 diabetes. ;Secondary Objective: The secondary objective is to investigate the effect of a 12 week linagliptin treatment on: - arginine bioavailability ratios (global arginine bioavailability ratio and arginine to ornithine ratio) - biochemical markers of endothelial function (sVCAM-1, sICAM-1, vWF) - the AUC of glucose, insulin and free fatty acids during the meal tolerance test;Primary end point(s): Changes in endothelial function (assessed by flow mediated dilatation – FMD) from baseline to 12 week.;Timepoint(s) of evaluation of this end point: Baseline, 12 weeks	—

Measure

Time frame

Main Objective: The primary objective is to investigate the impact of a 12 week linagliptin treatment on endothelial function in patients with early type 2 diabetes. ;Secondary Objective: The secondary objective is to investigate the effect of a 12 week linagliptin treatment on: - arginine bioavailability ratios (global arginine bioavailability ratio and arginine to ornithine ratio) - biochemical markers of endothelial function (sVCAM-1, sICAM-1, vWF) - the AUC of glucose, insulin and free fatty acids during the meal tolerance test;Primary end point(s): Changes in endothelial function (assessed by flow mediated dilatation – FMD) from baseline to 12 week.;Timepoint(s) of evaluation of this end point: Baseline, 12 weeks

—

Secondary

Measure	Time frame
Secondary end point(s): Changes from Baseline to week 12 in: - the arginine bioavailability ratios (global arginine bioavailability ratio and arginine to ornithine ratio) - in biochemical markers of endothelial function (sVCAM-1, sICAM-1, vWF) - in the AUC of glucose, insulin and free fatty acids during the meal tolerance test;Timepoint(s) of evaluation of this end point: Baseline, 12 weeks	—

Countries

Austria

Contacts

Public ContactHarald Sourij

Medizinische Universität Graz

ha.sourij@medunigraz.at004331638581310

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026