Status:
COMPLETED
Impact of Liraglutide on Endothelial Function and Microvascular Blood Flow in Type 2 Diabetes Mellitus
Lead Sponsor:
ikfe-CRO GmbH
Collaborating Sponsors:
Novo Nordisk A/S
IKFE Institute for Clinical Research and Development
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
30-65 years
Phase:
PHASE4
Brief Summary
The trial is a phase IV clinical trial investigating the impact of Liraglutide on endothelial function and microvascular blood flow in 44 patients with type 2 diabetes mellitus aged 30-65 and HbA1c ra...
Detailed Description
Type 2 Diabetes Mellitus (DM) is associated with increased cardiovascular risk and the majority of type 2 diabetic patients die due to the vascular complications of Diabetes Mellitus. In type 2 diabet...
Eligibility Criteria
Inclusion
- Diabetes Mellitus type 2
- HbA1c ≥ 5.5% and ≤ 7.0%
- Treatment with Metformin (daily dose 500 - 3000 mg monotherapy, the past 3 months)
- Age 30 - 65 years
Exclusion
- Pre-treatment with PPAR gamma agonists or DPP IV inhibitors or GLP-1 analogues within the last three months
- History of type 1 Diabetes Mellitus
- No full legal mental and physical ability to give informed consent
- Uncontrolled hypertension (systolic blood pressure \> 160 mmHg and/or diastolic blood pressure \> 90 mmHg)
- Anamnestic acute and chronic infections
- Inflammatory bowel disease and/or diabetic gastroparesis
- Anamnestic history of epilepsy
- Anamnestic history of hypersensitivity to the study drugs or to drugs with similar chemical structures
- History of severe or multiple allergies
- Treatment with any other investigational drug within 3 months before trial entry
- Progressive fatal disease
- History of drug or alcohol abuse in the past 2 years
- Liver disease with ASAT or ALAT above 3 times the upper normal limit
- Serum potassium \> 5.5 mmol/L
- Moderate to Severe Kidney disease with a GFR ≤ 60 ml/min
- Pregnancy or breast feeding
- 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
- 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
- History of dehydration, diabetic precoma, diabetic ketoacidosis or diabetic gastroparesis
- Acute (within the previous 2 days) or scheduled investigation with iodine containing radiopaque material
- Acute myocardial infarction, open heart surgery or cerebral event (stroke/TIA) within the previous 6 months
- Anamnestic uncontrolled unstable angina pectoris, pericarditis, myocarditis, endocarditis, haemodynamic relevant aortic stenosis, aortic aneurysma or heart insufficiency NYHA III or IV
- Anamnestic recent pulmonary embolism or pulmonary insufficiency
- Smoking within the last 6 months (\> 1 cigarette/day)
- Planned change in antidiabetic, lipid lowering or blood pressure medication
Key Trial Info
Start Date :
April 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2010
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT01208012
Start Date
April 1 2010
End Date
November 1 2010
Last Update
March 15 2011
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
IKFE Institute for Clinical Research and Development
Mainz, Germany, 55116