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Impact of Liraglutide on Endothelial Function and Microvascular Blood Flow in Type 2 Diabetes Mellitus
Lead sponsor
Asset
Liraglutide
Subcutaneous · GLP-1 agonist
Listed sites
1
Recruiting sites
—
Enrollment
44
actual
Study population
Type 2 diabetes
Key I/E criterion
•HbA1c 5.5-7%
Primary endpoint
•Increase of retinal blood flow after flicker stimulation of retinal endothelial
Footprint
Where this trial recruits
Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
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
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. Inflammatory bowel disease and/or diabetic gastroparesis
7. Anamnestic history of epilepsy
8. Anamnestic history of hypersensitivity to the study drugs or to drugs with similar chemical structures
9. History of severe or multiple allergies
10. Treatment with any other investigational drug within 3 months before trial entry
11. Progressive fatal disease
12. History of drug or alcohol abuse in the past 2 years
13. Liver disease with ASAT or ALAT above 3 times the upper normal limit
14. Serum potassium > 5.5 mmol/L
15. Moderate to Severe Kidney disease with a GFR ≤ 60 ml/min
16. Pregnancy or breast feeding
17. 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
18. 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
19. History of dehydration, diabetic precoma, diabetic ketoacidosis or diabetic gastroparesis
20. Acute (within the previous 2 days) or scheduled investigation with iodine containing radiopaque material
21. Acute myocardial infarction, open heart surgery or cerebral event (stroke/TIA) within the previous 6 months
22. Anamnestic uncontrolled unstable angina pectoris, pericarditis, myocarditis, endocarditis, haemodynamic relevant aortic stenosis, aortic aneurysma or heart insufficiency NYHA III or IV
23. Anamnestic recent pulmonary embolism or pulmonary insufficiency
24. Smoking within the last 6 months (> 1 cigarette/day)
25. Planned change in antidiabetic, lipid lowering or blood pressure medication
Endpoints (10)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Coverage by outcome category
Weight & body composition
1 endpointChange of body weight
Time frame:up to 2 weeks before baseline and after 6 and 12 weeks after baseline
Body weight, absolute change (kg)
change from baseline, improvement
Glycemic / diabetes
3 endpointsBlood glucose control
Time frame:timepoint 0 and after 6 and 12 weeks
Fasting glucose, change
change from baseline, improvement
LOINC 1558-6
Blood glucose control
Time frame:up to 2 weeks before baseline and after 6 and 12 weeks after baseline
HbA1c, change
change from baseline, improvement
LOINC 4548-4
Insulin/ intact Proinsulin ratio, C-peptide
Time frame:timepoint 0 and after 6 and 12 weeks
ratio, improvement
Heart failure
1 endpointChange of biomarker of heart failure
Time frame:timepoint 0 and after 6 and 12 weeks
NT-proBNP, change
change from baseline, improvement
Cardiometabolic biomarkers
2 endpointsCentral vascular elasticity
Time frame:timepoint 0 and after 6 and 12 weeks
change from baseline, improvement
Change of biomarkers of sub-clinical inflammation and cardiovascular risk
Time frame:timepoint 0 and after 6 and 12 weeks
hs-CRP, change
change from baseline, improvement
LOINC 30522-7
Safety / tolerability / PK
1 endpointSafety evaluation
Time frame:up to 2 weeks before baseline and after 12 weeks post baseline
descriptive
Other clinical outcomes
1 endpointThe difference in increase of retinal blood flow after flicker stimulation of retinal endothelial cells
Time frame:timepoint 0 and after 6 and 12 weeks
change from baseline, improvement
Other (unclassified)
1 endpointSkin endothelial function and Skin oxygenation
Time frame:timepoint 0 and after 6 and 12 weeks
change from baseline, descriptive
Publications (1)
Bibliography
Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.
Registry references + supporting bibliography
- Diabetic medicine : a journal of the British Diabetic Association2012 Sep (month)PMID22288732doi:10.1111/j.1464-5491.2012.03589.xvia clinicaltrials gov reference derived + pubmed nct search
Provenance
Sources
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.