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

Phase 1

Conditions: Diabetes mellitus Type 2
MedDRA version: 14.1Level: PTClassification code 10067585Term: Type 2 diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disorders
Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

Registration Number: EUCTR2013-000330-35-AT

Lead Sponsor: Medizinische Universität Graz

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 50

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

- 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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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:<br><br>- arginine bioavailability ratios (global arginine bioavailability ratio and arginine to ornithine ratio)<br>- biochemical markers of endothelial function (sVCAM-1, sICAM-1, vWF)<br>- 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 Outcome Measures

Name	Time	Method
Secondary end point(s): Changes from Baseline to week 12 in:<br>- the arginine bioavailability ratios (global arginine bioavailability ratio and arginine to ornithine ratio)<br>- in biochemical markers of endothelial function (sVCAM-1, sICAM-1, vWF)<br>- 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