Blood Pressure Outcomes With Liraglutide Therapy

What Was Tested

This registered phase 4 trial tested Liraglutide for low blood pressure and orthostatic hypotension.

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.

It had two arms (groups): Liraglutide (experimental) and Placebo (placebo comparator).

The registry classes the interventions as drug.

More on the Plan

Background: Type 2 diabetes is a worldwide health problem.

Study Objectives: Accordingly, the goal of this small study is to understand whether the blood pressure lowering effect of liraglutide is coupled to the release of vasoactive mediators which may stimulate natriuresis and/or diuresis and lower systolic blood pressure.

Study Design: Randomized, double-masked, cross-over study with treatment of liraglutide or placebo for 3 weeks, with an intervening washout period for 3 weeks, and cross-over to identical treatment with placebo or liraglutide for 3 weeks.

Study Patients: 20 patients with Type 2 Diabetes and Systolic Hypertension Endpoints: Change in vasoactive hormones, 24-hour ambulatory blood pressure, urinary sodium excretion patterns.

Who Took Part

22 actual participants took part.

It was open to people of any sex aged from 30 years up to 70 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Men and women between the ages of 30-70. 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 \[BPTru® or DinaMAP®\].

The full record lists 4 inclusion and 16 exclusion criteria; among the exclusions: individuals with secondary forms of hypertension including primary hyperaldosteronism, renal artery stenosis, obstructive sleep apnea, pheochromocytoma, hyperthyroidism, acromegaly, exogenous systemic glucocorticoid use, hypercortisolism; 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.

How the Study Was Run

Design: randomized, crossover and triple-blind.

Random assignment meant chance, not the researchers, decided who got Liraglutide and who got the comparison, which limits bias.

Each person switched between Liraglutide and the comparison at some point, usually with a gap in between.

As a double-blind Liraglutide study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant, investigator and outcomes assessor.

It started in 2013-01 with completion listed for 2014-01.

It ran at 1 site in Canada.

Its stated primary purpose is basic science.

What Was Measured

Primary outcome: Change in plasma ANP level at 1 Day. Change in plasma ANP level at 21 Days.

It also tracked 8 secondary outcomes, for example Change in mean 24-Hr systolic BP, liraglutide compared to crossover with placebo (baseline-subtracted), Change in mean 24-hr diastolic BP, liraglutide compared to crossover with placebo (baseline-subtracted), Change in mean 24-hr HR, liraglutide compared to crossover with placebo (baseline-subtracted), Office-measured systolic BP; Treatment difference for liraglutide compared to crossover with placebo, Office-measured diastolic BP;Treatment difference for liraglutide compared to crossover with placebo and Office-measured heart rate;Treatment difference for liraglutide compared to crossover with placebo.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Liraglutide in 22 people with low blood pressure and orthostatic hypotension.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Liraglutide compound page, Low blood pressure and orthostatic hypotension research.