Impact of Liraglutide on Endothelial Function and Microvascular Blood Flow in Type 2 Diabetes Mellitus - Lira-Vasc-001

• Conditions: Type 2 Diabetes Mellitus

• Registration Number: EUCTR2010-018619-14-DE
• Lead Sponsor: ikfe GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-02-16
• Last Update Posted: 19 November 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Diabetes Mellitus type 2
2. HbA1c = 5.5% and = 7.0%
3. Treatment with Metformin (daily dose 500 – 3000 mg monotherapy, the past 3 months)
4. Age 30 – 65 years

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
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Pre-treatment with PPAR gamma agonists or DPP IV inhibitors or GLP-1 analogues within the last three months
2. History of type 1 Diabetes Mellitus
3. No full legal mental and physical ability to give informed consent
4. Uncontrolled hypertension (systolic blood pressure > 160 mmHg and/or diastolic blood pressure > 90 mmHg)
5. Anamnestic acute and chronic infections
6. Anamnestic history of epilepsy
7. Anamnestic history of hypersensitivity to the study drugs or to drugs with similar chemical structures
8. History of severe or multiple allergies
9. Treatment with any other investigational drug within 3 months before trial entry
10. Progressive fatal disease
11. History of drug or alcohol abuse in the past 2 years
12. Liver disease with ASLT or ALT above 3 times the upper normal limit
13. Serum potassium > 5.5 mmol/L
14. Moderate to Servere Kidney disease with a GFR = 60 ml/min
15. Pregnancy or breast feeding
16. Sexually active woman of childbearing potential not practicing a highly effective method of birth control as defined as those which result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, hormonal IUDs, sexual abstinence or vasectomised partner
17. Have had more than one unexplained episode of severe hypoglycaemia (defined as requiring assistance of another person due to disabling hypoglycaemia) within 6 months prior to screening visit
18. History of dehydration, diabetic precoma, diabetic ketoacidosis or diabetic gastroparesis
19. Acute (within the previous 2 days) or scheduled investigation with iodine containing radiopaque material
20. Acute myocardial infarction, open heart surgery or cerebral event (stroke/TIA) within the previous 6 months
21. Anamnestic uncontrolled unstable angina pectoris, pericarditis, myocarditis, endocarditis, haemodynamic relevant aortic stenosis or aortic aneurysma
22. Anamnestic recent pulmonary embolism or pulmonary insufficiency
23. Smoking within the last 6 months (< 1 cigarette/day)
24. Planned change in antidiabetic, lipid lowering or blood pressure medication

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Investigate vascular and endothelial effects of Liraglutide treatment in type 2 diabetic patients previously being treated with Metformin only;Secondary Objective: 1.To assess the effect of Liraglutide on central arterial elasticity <br>2.To assess the effect of Liraglutide on skin endothelial function and skin oxygenation <br>3.To assess the effect of Liraglutide on blood glucose control<br>4.To assess the effect of Liraglutide on subclinical inflammation <br>5.To assess the effect of Liraglutide on markers for atherogenesis<br>6.To assess the effect of Liraglutide on ß cell function <br>7.To evaluate the collected safety data <br>;Primary end point(s): Difference in increase of retinal blood flow after flicker stimulation of retinal endothelial cells.