Time Course of the Blood Pressure Lowering Effect of Liraglutide Therapy in Type 2 Diabetes

What Was Tested

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

The time course and the mechanism behind this effect are unknown.

Objectives: To evaluate the time course of the antihypertensive effect of liraglutide treatment in patients with type 2 diabetes Design: Open-label study with intervention and subsequent washout period Patient Population: 35 hypertensive (SBP ≥130 mm Hg and DBP ≥80 mmHg) patients with type 2 diabetes.

It had 1 arm (groups): Liraglutide (experimental).

Single-group study were participants recieve Liraglutide.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 32 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

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

Examples of who could join: Must give written informed consent before participation. Patient information and consent form must be approved by the Danish Medicines Agency and the Regional Scientific Ethical Committee. Male or female patients \> 18 years with type 2 diabetes (WHO criteria). Patients must be on treatment with metformin. Any form of treatment with SU compounds will be discontinued and washed out for two weeks prior to the start of study drug. Patients must be on stable hypoglycemic medication for at least two weeks before the first visit. Must be able to communicate with the investigator.

The full record lists 8 inclusion and 14 exclusion criteria; among the exclusions: ongoing insulin therapy; BP \> 170/105 mm Hg at baseline; type 1 diabetes mellitus.

How the Study Was Run

Design: single-group and open-label.

Everyone knew when Liraglutide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2012-08 with completion listed for 2013-07.

It ran at 1 site in Denmark.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change in ambulatory blood pressure (time frame: 50 days).

It also tracked 2 secondary outcomes, for example Change in ECV and Washout analysis.

What This Means in Plain Language

Put simply, this is a phase 4 trial of Liraglutide in 32 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.