GLP-1 Peptide Atlas, by Delfa

← Trials/Trial dossier/NCT02299388

CompletedPhase 4Results posted

To Evaluate the Effect of Liraglutide on Ambulatory Blood Pressure-A Pilot Study

Lead sponsor

Tulane University School of Medicine

Asset

Liraglutide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

actual

Study population

Hypertension, Type 2 diabetes

Key I/E criterion

•HbA1c 7-10.5%

Primary endpoint

•Systolic BP, change

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 IDNCT02299388

Org study ID523963-1

Timeline

Milestones

Study first posted2014-11-24estimated

Results first posted2019-05-08actual

Last update posted2021-01-27actual

Study start2014-10 (month precision)

Primary completion2016-11actual (month precision)

Study completion2016-12actual (month precision)

Assets

Investigational agents

Liraglutide

Study populations

Who this study enrolls

HypertensionType 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years

Maximum age75 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Type 2 diabetes, as an adjunct to diet and exercise to improve glycemic control (as per approved label.

•HbA1c>7% and ≤10.5% at randomization.

•Men and women of 18-75 years of age.

•Women of childbearing potential must agree to use contraception or must not otherwise be at risk of becoming pregnant. A urine pregnancy test will be done at the time of screening and then every 4 weeks for the duration of 8 weeks. If positive, this will be confirmed with a serum pregnancy test which if positive, appropriate action will be taken as outlined in the detailed protocol.

•Blood pressure≥ 130/80 mm Hg and ≤160/100mmHg on stable treatment (no change in anti hypertensive treatment for 3 months prior to screening) or no treatment. No change in treatment for BP over 8 weeks of the study will be allowed.

•Patient understands the study procedures, alternative treatments are available, and the risks involved with the study, and voluntarily agree to participate by providing written informed consent.

Exclusion criteria

•1. Type 1 diabetes and/or history of ketoacidosis determined by medical history.

2. History of severe diabetic or autonomic neuropathy, gastroparesis or limb ulceration or amputation.

3. Therapy with DPP-4 inhibitor, or GLP -1 analog or receptor agonist in the past 6 months.

4. Pregnant, breast-feeding or the intention of becoming pregnant or not using adequate contraceptive measures.

5. Patients on corticosteroids within 3 months or recurrent continuous corticosteroid treatment (>2 weeks).

6. Use of weight loss drugs within 3 months of screening or weight loss of ≥10 % in the last 6 months.

7. Surgery in the past 30 days prior to screening and/or any serious or chronic illness within 6 months or anticipated surgery during the trial period.

8. Serum creatinine >1.4mg/dL (women)/>1.5mg/dL (men). 9. Serum Triglyceride Level >500 mg/dL. 10. History of pancreatitis. 11. History of drug or alcohol abuse. 12. Poor mental function or any reason to expect patient difficulty in complying with study requirements.

13. Contraindications to Liraglutide: Personal or family history of medullary thyroid cancer or MEN-2 syndrome 14. Known or suspected allergy to Liraglutide. 15. Diagnosed Secondary hypertension.

Endpoints (14)

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

Other (unclassified)

Cardiometabolic biomarkers

12 endpoints

Primary/registry result

Change in Systolic Blood Pressure as Measured by Ambulatory Blood Pressure Monitors.

Time frame:Baseline and 8 Weeks

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Posted result

Group	Value (mean), mm/Hg	95% CI
Liraglutide	-4.88	-18.6 – 13.6
Placebo	-5.45	-6.9 – -4.0

Primary/protocol endpoint

Change in Systolic Blood Pressure as Measured by Ambulatory Blood Pressure Monitors.

Time frame:Baseline and 8 Weeks

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Secondary/registry result

Change in Pulse Pressure, Mean Arterial, Diastolic and Nocturnal Blood Pressures.

Time frame:Baseline and 8 Weeks

Mean arterial pressure

change from baseline, improvement

Posted result

Group	Value (mean), mm/Hg	95% CI
LiraglutideOverall Systolic Pressure	-4.4	-18.5 – 11.8
Overall Diastolic Pressure	-1.8	-7.5 – 9.5
Overall Pulse Pressure	-2.7	-11 – 1.4
Mean Arterial Pressure	-2.6	-11.2 – 10.3
Nocturnal Systolic Pressure	1.15	-18.5 – 14.7
Nocturnal Diastolic Pressure	1.0	-12.1 – 19
PlaceboOverall Systolic Pressure	-5.4	-9.4 – -1.4
Overall Diastolic Pressure	-3.3	-9.8 – 3.2
Overall Pulse Pressure	0.4	0.4 – 0.4
Mean Arterial Pressure	-4	-9.7 – 1.7
Nocturnal Systolic Pressure	-2.3	-25.3 – 20.6
Nocturnal Diastolic Pressure	-0.8	-14 – 12.5

Secondary/protocol endpoint

Change in Pulse Pressure, Mean Arterial, Diastolic and Nocturnal Blood Pressures.

Time frame:Baseline and 8 Weeks

Mean arterial pressure

change from baseline, improvement

componentsMean arterial pressure, Diastolic BP, change, Systolic BP, change

Other/protocol endpoint

Change in Endothelial Function. (Using Endo PAT)

Time frame:Baseline and 8 Weeks

change from baseline, improvement

Other/protocol endpoint/low confidence

Change in Autonomic Function (Heart Rate Variability Using Endo PAT.)

Time frame:Baseline and 8 Weeks

change from baseline, improvement

Other/protocol endpoint

Change in Urinary Sodium Excretion

Time frame:Baseline and 8 Weeks

change from baseline, improvement

Other_pre_specified/registry result

Change in Endothelial Function. (Using Endo PAT)

Time frame:Baseline and 8 Weeks

change from baseline, improvement

Other_pre_specified/registry result

Change in Autonomic Function (Heart Rate Variability Using Endo PAT.)

Time frame:Baseline and 8 Weeks

change from baseline, improvement

Other_pre_specified/registry result

Change in Renin-Angiotensin System (Plasma Renin and Aldosterone Levels and Urine Angiotensinogen Levels)

Time frame:Baseline and 8 Weeks

change from baseline, improvement

componentsplasma renin level, plasma aldosterone level, urine angiotensinogen level

Other_pre_specified/registry result/low confidence

Change in Catecholamines (Collecting 24 Hrs Urine for Metanephrines and Catecholamines.)

Time frame:Baseline and 8 Weeks

change from baseline, descriptive

Other_pre_specified/registry result/low confidence

Change in Urinary Sodium Excretion

Time frame:Baseline and 8 Weeks

change from baseline, descriptive

Other (unclassified)

2 endpoints

Other/protocol endpoint/low confidence

Change in Renin-Angiotensin System (Plasma Renin and Aldosterone Levels and Urine Angiotensinogen Levels)

Time frame:Baseline and 8 Weeks

change from baseline, improvement

Other/protocol endpoint/low confidence

Change in Catecholamines (Collecting 24 Hrs Urine for Metanephrines and Catecholamines.)

Time frame:Baseline and 8 Weeks

change from baseline, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableClinicalTrials.gov results section

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.