Blood Pressure Outcomes With Liraglutide Therapy

NCT01755572 | Completed Phase 4

• 1 other identifier: MSH-12-0020-A
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Type 2 Diabetes; Systolic Hypertension

Keywords

Type 2 Diabetes; Hypertension; Liraglutide; GLP-1

Outcome Measures

Primary Outcomes (2)

• Change in plasma ANP level at 1 Day

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

  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 in plasma ANP level at 21 Days

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

  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

Secondary Outcomes (8)

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

  21 days

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

  21 days

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

  21 days

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

  21 days

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

  21 days

Other Outcomes (11)

• Change in HbA1c%

  21 days

• Change in Fasting Blood Glucose

  21 days

• Change in Total Cholesterol

  21 days

Study Arms (2)

Liraglutide

EXPERIMENTAL

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

Drug: Liraglutide; Drug: Placebo

Placebo

PLACEBO COMPARATOR

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

Drug: Liraglutide; Drug: Placebo

Interventions

Liraglutide DRUG

Single cross-over study, 1 arm starting with liraglutide for 3 weeks crossed-over to placebo for 3 weeks, and 1 arm starting with placebo with cross-over to liraglutide for 3 weeks.

Also known as: Victoza

Liraglutide; Placebo

Placebo DRUG

Single cross-over study, 1 arm starting with liraglutide for 3 weeks crossed-over to placebo for 3 weeks, and 1 arm starting with placebo with cross-over to liraglutide for 3 weeks.

Liraglutide; Placebo

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women between the ages of 30-70.
• Patients with Type 2 Diabetes \[diagnosed by their physician\] with a serum HbA1c ≥ 6.5% and ≤ 10%.
• Patients currently prescribed 0-2 oral hypoglycemic agents by their physician.
• Patients with systolic blood pressure ≥ 130 mmHg and ≤ 180 mmHg measured by an automated oscillometric blood pressure device \[BPTru® or DinaMAP®\].

You may not qualify if:

• Individuals with Type 1 Diabetes, \[or secondary forms of diabetes including gestational diabetes, transplant-associated, glucocorticoid-associated, latent-onset diabetes of the adult, or known monogenic forms of diabetes\].
• 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.
• 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.
• Individuals with secondary forms of hypertension including primary hyperaldosteronism, renal artery stenosis, obstructive sleep apnea, pheochromocytoma, hyperthyroidism, acromegaly, exogenous systemic glucocorticoid use, hypercortisolism.
• 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.
• 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 \[bolus, pre-mixed, or prandial\].
• Liver failure, including liver cirrhosis or non-alcoholic fatty liver disease.
• Dependence upon alcohol, \>14 servings per week if male, \>9 servings per week if female.
• 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 \[Multiple Endocrine Neoplasia Type 2\].
• Individuals with severe systolic hypertension, SBP (systolic blood pressure) ≥ 181 mmHg measured by an automated oscillometric blood pressure device \[BPTru® or DinaMAP®\].
• Individuals with severe diastolic hypertension, DBP (diastolic blood pressure) ≥ 100 mmHg measured by an automated oscillometric blood pressure device \[BPTru® or DinaMAP®\].
• 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.
• 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.
• Current involvement, or any recent involvement \[within 3 months\] in any other clinical trial involving an investigational product.
• Unwillingness to perform daily sc injection with study drug therapy for duration of 21 days throughout 2 treatment phases.

Sponsors & Collaborators

• Mount Sinai Hospital, Canada: lead
• Novo Nordisk A/S: collaborator

Study Sites (1)

Leadership Sinai Centre for Diabetes, Mount Sinai Hospital, Canada

Toronto, Ontario, Canada

Location

Related Publications (1)

• Lovshin JA, Barnie A, DeAlmeida A, Logan A, Zinman B, Drucker DJ. Liraglutide promotes natriuresis but does not increase circulating levels of atrial natriuretic peptide in hypertensive subjects with type 2 diabetes. Diabetes Care. 2015 Jan;38(1):132-9. doi: 10.2337/dc14-1958. Epub 2014 Nov 20.

  PMID: 25414155 RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Isolated Systolic Hypertension; Hypertension

Interventions

Liraglutide

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Essential Hypertension; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide 1; Glucagon-Like Peptides; Proglucagon; Gastrointestinal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Dr. Daniel J. Drucker, MD

  Samuel Lunenfeld Research Institute

  PRINCIPAL INVESTIGATOR

• Dr. Julie A. Lovshin, MD, PhD

  Samuel Lunenfeld Research Institute

  STUDY DIRECTOR

• Dr. Bernard Zinman, MD

  Leadership Sinai Centre for Diabetes

  STUDY DIRECTOR

• Dr. Alexander A. Logan, MD

  Samuel Lunenfeld Research Institute

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2012
• First Posted: December 24, 2012
• Study Start: January 1, 2013
• Primary Completion: January 1, 2014
• Study Completion: March 1, 2014
• Last Updated: March 25, 2015

Record last verified: 2015-03

Locations

CA (1)