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LAED001

CompletedPhase 4

Differences in Endothelial Function Amongst Sitagliptin and Liraglutide Users

Differences in Endothelial Function Amongst Sitagliptin and Liraglutide Users: A Randomized, Open-label, Parallel-group and Active Controlled Trial

Lead sponsor

Anna Cruceta

Asset

Liraglutide

Subcutaneous · GLP-1 agonist

Listed sites

1

Recruiting sites

Enrollment

13

actual

Study population

Dyslipidemia, Type 2 diabetes

Key I/E criterion

HbA1c 7-9.5%

Primary endpoint

Assess the effects on endothelial function of a three month treatment

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 IDNCT01785043
Org study IDLAED001

Timeline

Milestones

Study first posted2013-02-06estimated
Last update posted2015-09-15estimated
Study start2013-03 (month precision)
Primary completion2014-03actual (month precision)
Study completion2014-09actual (month precision)

Assets

Investigational agents

Study populations

Who this study enrolls

DyslipidemiaType 2 diabetes

Eligibility

Who can enroll

Minimum age45 Years
Maximum age65 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

1. Informed consent obtained before any trial-related activities. (Trial-related activities are any procedure that would not have been performed during normal management of the subject.)

2. Male or female patients between 45 and 65 years old

3. Pre-existing type 2 diabetes with HbA1c between 7.0 and 9.5%

4. Triglycerides >1.68 mmol/L

5. HDL cholesterol <1.29 mmol/L in women and <1.04 mmol/L in men

6. Systolic blood pressure (SBP) <130 mmHg and diastolic blood pressure (DBP) <85 mmHg or treatment with antihypertensive agents

Exclusion criteria

1. Known or suspected hypersensitivity to trial product(s) or related products

2. Previous participation in this trial. Participation is defined as being randomised.

3. Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive, or males who are sexually active and not surgically sterilised, who or whose partner are not using adequate contraception

4. Moderate or severe renal dysfunction (creatinine clearance <60 ml/min)

5. Previous type 2 diabetes treatment apart from metformin or insulin

6. Current smoker or history of smoking within 6 months prior to screening.

7. Evidence of overt cardiovascular disease, (documented coronary heart disease, class II-IV congestive heart failure, cerebrovascular disease, or peripheral vascular disease).

8. Caffeine intake within 24 hours of endothelial function measurements.

9. Use of any drug with known clinically significant sympathetic or parasympathetic effects, as determined by the Investigator.

10. Initiation or change (dose or treatment regimen) in concomitant blood pressure-lowering medication within 4 weeks prior to screening and throughout the day.

11. The receipt of any investigational medicinal product within 6 months prior to screening.

12. Presence of cancer or other significant medical condition

13. Inability to follow verbal or written instructions

Endpoints (2)

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

Cardiometabolic biomarkers
1
Other (unclassified)
1

Cardiometabolic biomarkers

1 endpoint
Primary/protocol endpoint

Assess the effects on endothelial function of a three month treatment with Liraglutide compared to Sitagliptin.

Time frame:3months

change from baseline, improvement

Other (unclassified)

1 endpoint
Secondary/protocol endpoint/low confidence

The evaluation of other emerging potential cardiovascular risk factors

Time frame:3months

descriptive

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.