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CompletedPhase 4

Impact of Liraglutide on Endothelial Function and Microvascular Blood Flow in Type 2 Diabetes Mellitus

Lead sponsor

ikfe-CRO GmbH

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

NCT IDNCT01208012
Org study IDLira-Vasc-001

Timeline

Milestones

Study first posted2010-09-23estimated
Last update posted2011-03-15estimated
Study start2010-04 (month precision)
Primary completion2010-11actual (month precision)
Study completion2010-11actual (month precision)

Assets

Investigational agents

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age30 Years
Maximum age65 Years
SexAll
Healthy volunteersNot accepted

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

Glycemic / diabetes
3
Cardiometabolic biomarkers
2
Weight & body composition
1
Heart failure
1
Safety / tolerability / PK
1
Other clinical outcomes
1
Other (unclassified)
1

Weight & body composition

1 endpoint
Secondary/protocol endpoint

Change 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 endpoints
Secondary/protocol endpoint

Blood glucose control

Time frame:timepoint 0 and after 6 and 12 weeks

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

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

Secondary/protocol endpoint/low confidence

Insulin/ intact Proinsulin ratio, C-peptide

Time frame:timepoint 0 and after 6 and 12 weeks

ratio, improvement

Heart failure

1 endpoint
Secondary/protocol endpoint

Change 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 endpoints
Secondary/protocol endpoint

Central vascular elasticity

Time frame:timepoint 0 and after 6 and 12 weeks

change from baseline, improvement

Secondary/protocol endpoint

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 endpoint
Secondary/protocol endpoint

Safety evaluation

Time frame:up to 2 weeks before baseline and after 12 weeks post baseline

descriptive

Other clinical outcomes

1 endpoint
Primary/protocol endpoint

The 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 endpoint
Secondary/protocol endpoint/low confidence

Skin 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

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

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.