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Trial · Interventional

CompletedPhase 4Registry data

Blood Pressure Outcomes With Liraglutide Therapy

Short name BOLT

Overview

Status
Completed
Phase
Phase 4
Enrollment
22 participants (actual)
Sponsor
Mount Sinai Hospital, Canada · Other
Design
Randomized · Triple masking
Countries
1 country

Canada

Start
Jan 2013
Primary completion
Jan 2014
Completion
Mar 2014
First posted
24 Dec 2012 (estimated)
Last update posted
25 Mar 2015 (estimated)
Conditions
Type 2 Diabetes · Systolic Hypertension

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201320142015
  1. Ph 4

    BOLT

    NCT01755572

    Jan 2013 to Mar 2014

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

Purpose: The purpose of this study is to further study the mechanism by which liraglutide, a relatively new anti-hyperglycemic medication, might lower blood pressure in patients with Type 2 diabetes and high blood pressure.

Interventions

  • LiraglutideDrug
  • PlaceboDrug

Arms2

  • Experimental

    Liraglutide

    Liraglutide 0.6mg for 7 days, liraglutide 1.2mg for 7 days, liraglutide 1.8mg for 7 days

  • Placebo comparator

    Placebo

    Placebo 0.6mg sc for 3 weeks, Placebo 1.2mg sc for 3 weeks, Placebo 1.8mg for 3 weeks.

Primary outcomes2

Outcomes the sponsor listed as primary.

  1. 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

    Registry description

    +16.72 pg/mL, P = 0.24, 95% CI \[-12.1, +45.5\] at 2 hours

  2. 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

    Registry description

    -17.42 pg/mL, 95% CI \[-36.0, +1.21\] at 2 hours

Secondary outcomes(8)
  1. 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

    Registry description

    median change +14.18 mmol/L liraglutide vs. placebo (statistically significant, Wilcoxon rank sum)

  2. 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

    Registry description

    median change +4.24 mmol/L nighttime, liraglutide vs. placebo (statistically significant, Wilcoxon Rank Sum)

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

    Time frame · 21 days

    Registry description

    +2.33 ± 1.67, p=0.18;Treatment difference liraglutide (1.8 mg) vs. placebo LSMD (±SE), p value

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

    Time frame · 21 days

    Registry description

    +3.78 ± 1.34, p=0.01;Treatment difference liraglutide (1.8 mg) vs. placebo LSMD (±SE), p value

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

    Time frame · 21 days

    Registry description

    +5.21 ± 2.42, p=0.05; Treatment difference liraglutide (1.8 mg) vs. placebo LSMD (±SE), p value

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

    Time frame · 21 days

    Registry description

    -2.35 mmHg (3.49), p=0.51;Treatment difference liraglutide (1.8 mg) vs. placebo LSMD (±SE), p value

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

    Time frame · 21 days

    Registry description

    +3.6 mmHg (2.33), p=0.14;Treatment difference liraglutide (1.8 mg) vs. placebo LSMD (±SE), p value

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

    Time frame · 21 days

    Registry description

    +9.25 (3.51), p=0.02;Treatment difference liraglutide (1.8 mg) vs. placebo LSMD (±SE), p value

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2015

10 results

Liraglutide promotes natriuresis but does not increase circulating levels of atrial natriuretic peptide in hypertensive subjects with type 2 diabetes.

Lovshin et al. 2015Diabetes carecited by 152

PMID 25414155DOI 10.2337/dc14-1958PUB-25414155

Full text at the publisher10 results

Eligibility

Who could join, as posted.

Sex
All
Age
from 30 Years up to 70 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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.

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