Type 2 Diabetes Mellitus
Conditions
Sponsors
ikfe GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 2. To assess the effect of Liraglutide on skin endothelial function and skin oxygenation 3. To assess the effect of Liraglutide on blood glucose control 4. To assess the effect of Liraglutide on subclinical inflammation 5. To assess the effect of Liraglutide on markers for atherogenesis 6. To assess the effect of Liraglutide on ß cell function 7. To evaluate the collected safety data ;Primary end point(s): Difference in increase of retinal blood flow after flicker stimulation of retinal endothelial cells. | — |
Countries
Germany
Outcome results
None listed