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BOLT
CompletedPhase 4Blood Pressure Outcomes With Liraglutide Therapy
Hormonal Regulation of Systolic Blood Pressure in Response to the GLP-1 (Glucagon-Like Peptide-1) Receptor Agonist, Liraglutide.
Lead sponsor
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
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
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
Weight & body composition
2 endpointsChange in Body Weight
Time frame:21 days
Body weight, absolute change (kg)
change from baseline, improvement
Change in BMI (Body Mass Index)
Time frame:21 days
BMI, change
change from baseline, improvement
Glycemic / diabetes
2 endpointsChange in HbA1c%
Time frame:21 days
HbA1c, change
change from baseline, improvement
LOINC 4548-4
Change in Fasting Blood Glucose
Time frame:21 days
Fasting glucose, change
change from baseline, improvement
LOINC 1558-6
Renal / kidney
1 endpointChange in eGFR (estimated Glomerular Filtration Rate)
Time frame:21 days
eGFR, change
change from baseline, improvement
LOINC 98979-8
Cardiometabolic biomarkers
11 endpointsChange 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
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
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
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
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
Office-measured heart rate;Treatment difference for liraglutide compared to crossover with placebo
Time frame:21 days
Heart rate, change
change from baseline, improvement
Change in Total Cholesterol
Time frame:21 days
Total cholesterol, change
change from baseline, improvement
LOINC 2093-3
Change in LDL Cholesterol
Time frame:21 days
LDL-C, change
change from baseline, improvement
LOINC 13457-7
Change in Plasma CRP
Time frame:21 days
hs-CRP, change
change from baseline, improvement
LOINC 30522-7
Change in Triglycerides
Time frame:21 days
Triglycerides, change
change from baseline, improvement
LOINC 2571-8
Change in HDL
Time frame:21 days
HDL-C, change
change from baseline, improvement
LOINC 2085-9
Other (unclassified)
5 endpointsChange 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
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
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
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
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
- Diabetes care2015 Jan (month)PMID25414155doi:10.2337/dc14-1958via CT.gov reference + pubmed nct search
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.