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LAED001
CompletedPhase 4Differences 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
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
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
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 endpointAssess 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 endpointThe evaluation of other emerging potential cardiovascular risk factors
Time frame:3months
descriptive
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.