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BOLT

CompletedPhase 4

Blood Pressure Outcomes With Liraglutide Therapy

Hormonal Regulation of Systolic Blood Pressure in Response to the GLP-1 (Glucagon-Like Peptide-1) Receptor Agonist, Liraglutide.

Asset

Liraglutide

Subcutaneous · GLP-1 agonist

Listed sites

1

Recruiting sites

Enrollment

22

actual

Study population

Hypertension, Type 2 diabetes

Key I/E criterion

HbA1c 6.5-10%

Primary endpoint

Plasma ANP level

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 IDNCT01755572
Org study IDMSH-12-0020-A

Timeline

Milestones

Study first posted2012-12-24estimated
Last update posted2015-03-25estimated
Study start2013-01 (month precision)
Primary completion2014-01actual (month precision)
Study completion2014-03actual (month precision)

Assets

Investigational agents

Study populations

Who this study enrolls

HypertensionType 2 diabetes

Eligibility

Who can enroll

Minimum age30 Years
Maximum age70 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

1. Men and women between the ages of 30-70.

2. Patients with Type 2 Diabetes [diagnosed by their physician] with a serum HbA1c ≥ 6.5% and ≤ 10%.

3. Patients currently prescribed 0-2 oral hypoglycemic agents by their physician.

4. Patients with systolic blood pressure ≥ 130 mmHg and ≤ 180 mmHg measured by an automated oscillometric blood pressure device [BPTru® or DinaMAP®].

Exclusion criteria

1. Individuals with Type 1 Diabetes, [or secondary forms of diabetes including gestational diabetes, transplant-associated, glucocorticoid-associated, latent-onset diabetes of the adult, or known monogenic forms of diabetes].

2. Elevated LVEDP (left ventricular end-diastolic pressure) including congestive heart failure, cardiomyopathy, atrial fibrillation, any valvular heart disease (rated by echocardiography and/or clinically by a cardiologist as moderate or severe in nature), and or elevated RVEDP (right ventricular end-diastolic pressure) including pulmonary hypertension.

3. Moderate renal failure or dysfunction as indicated by a serum creatinine >150 μmol/l, and/or an estimated GFR (Glomerular Filtration Rate) less than 59 ml/min per 1.73m2.

4. Individuals with secondary forms of hypertension including primary hyperaldosteronism, renal artery stenosis, obstructive sleep apnea, pheochromocytoma, hyperthyroidism, acromegaly, exogenous systemic glucocorticoid use, hypercortisolism.

5. Current pregnancy, or recent pregnancy within the last 3 months, or current breast-feeding. Female patients of child bearing potential [premenopausal, or not surgically sterile] who are unwillingly to have a baseline serum pregnancy test, and/or who are unwillingly to use active contraception throughout the duration of the study.

6. Use within the last 3 months of any DPP-IV (Dipeptidyl Peptidase) inhibitor, GLP-1 receptor agonist [liraglutide, exenatide (ExBID, or Ex QW)], or insulin [bolus, pre-mixed, or prandial].

7. Liver failure, including liver cirrhosis or non-alcoholic fatty liver disease.

8. Dependence upon alcohol, >14 servings per week if male, >9 servings per week if female.

9. Prior history of any clinical presentation consistent with pancreatitis [acute or chronic], or a history of medullary thyroid cancer, c-cell hyperplasia or history of multiple endocrine neoplasia syndromes which predisposes to medullary thyroid cancer [Multiple Endocrine Neoplasia Type 2].

10. Individuals with severe systolic hypertension, SBP (systolic blood pressure) ≥ 181 mmHg measured by an automated oscillometric blood pressure device [BPTru® or DinaMAP®].

11. Individuals with severe diastolic hypertension, DBP (diastolic blood pressure) ≥ 100 mmHg measured by an automated oscillometric blood pressure device [BPTru® or DinaMAP®].

12. Individuals currently prescribed an insulin secretagogue [sulphonylurea] unwillingly to decrease their dose by 50% prior to the start of, and for the duration of the study.

13. Individuals with resting tachycardia of >100 bpm or individuals who have a prior history of known conduction abnormalities associated with tachycardia including atrial fibrillation, atrial flutter, prolongation of PR interval, or ventricular tachycardias.

14. Current involvement, or any recent involvement [within 3 months] in any other clinical trial involving an investigational product.

15. Unwillingness to perform daily sc injection with study drug therapy for duration of 21 days throughout 2 treatment phases.

16. Individuals who are currently taking or who have taken diuretic therapy in the past 3 months.

Endpoints (21)

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
11
Other (unclassified)
5
Weight & body composition
2
Glycemic / diabetes
2
Renal / kidney
1

Weight & body composition

2 endpoints
Other/protocol endpoint

Change in Body Weight

Time frame:21 days

Body weight, absolute change (kg)

change from baseline, improvement

Other/protocol endpoint

Change in BMI (Body Mass Index)

Time frame:21 days

BMI, change

change from baseline, improvement

Glycemic / diabetes

2 endpoints
Other/protocol endpoint

Change in HbA1c%

Time frame:21 days

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Other/protocol endpoint

Change in Fasting Blood Glucose

Time frame:21 days

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Renal / kidney

1 endpoint
Other/protocol endpoint

Change in eGFR (estimated Glomerular Filtration Rate)

Time frame:21 days

eGFR, change

change from baseline, improvement

LOINC 98979-8

Cardiometabolic biomarkers

11 endpoints
Secondary/protocol endpoint

Change in mean 24-Hr systolic BP, liraglutide compared to crossover with placebo (baseline-subtracted)

Time frame:21 days

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Secondary/protocol endpoint

Change in mean 24-hr diastolic BP, liraglutide compared to crossover with placebo (baseline-subtracted)

Time frame:21 days

Diastolic BP, change

change from baseline, improvement

LOINC 8462-4

Secondary/protocol endpoint

Change in mean 24-hr HR, liraglutide compared to crossover with placebo (baseline-subtracted)

Time frame:21 days

Heart rate, change

change from baseline, improvement

Secondary/protocol endpoint

Office-measured systolic BP; Treatment difference for liraglutide compared to crossover with placebo

Time frame:21 days

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Secondary/protocol endpoint

Office-measured diastolic BP;Treatment difference for liraglutide compared to crossover with placebo

Time frame:21 days

Diastolic BP, change

change from baseline, improvement

LOINC 8462-4

Secondary/protocol endpoint

Office-measured heart rate;Treatment difference for liraglutide compared to crossover with placebo

Time frame:21 days

Heart rate, change

change from baseline, improvement

Other/protocol endpoint

Change in Total Cholesterol

Time frame:21 days

Total cholesterol, change

change from baseline, improvement

LOINC 2093-3

Other/protocol endpoint

Change in LDL Cholesterol

Time frame:21 days

LDL-C, change

change from baseline, improvement

LOINC 13457-7

Other/protocol endpoint

Change in Plasma CRP

Time frame:21 days

hs-CRP, change

change from baseline, improvement

LOINC 30522-7

Other/protocol endpoint

Change in Triglycerides

Time frame:21 days

Triglycerides, change

change from baseline, improvement

LOINC 2571-8

Other/protocol endpoint

Change in HDL

Time frame:21 days

HDL-C, change

change from baseline, improvement

LOINC 2085-9

Other (unclassified)

5 endpoints
Primary/protocol endpoint/low confidence

Change in plasma ANP level at 1 Day

Time frame:Change from Baseline compared in plasma ANP following 1 dose of liraglutide (0.6 mg) compared to crossover treatment with placebo at the 2-hour timepoint

change from baseline, descriptive

Primary/protocol endpoint/low confidence

Change in plasma ANP level at 21 Days

Time frame:Change from Baseline in plasma ANP following 21 days of liraglutide (titrated to 1.8 mg) compared to crossover treatment with placebo at the 2-hour timepoint

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change in mean 24-Hr urinary sodium excretion rate following 21 days of liraglutide (titrated 1.8mg) compared to crossover with placebo (baseline-subtracted)

Time frame:21 days

change from baseline, descriptive

Secondary/protocol endpoint/low confidence

Change in mean Nighttime urinary sodium excretion rate following 21 days of liraglutide (titrated 1.8mg) compared to crossover with placebo (baseline-subtracted)

Time frame:21 days

change from baseline, descriptive

Other/protocol endpoint/low confidence

Change in Plasma Angiotensin II

Time frame:21 days

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.