A Study of the Effect of LY2189265 on Blood Pressure and Heart Rate in Type 2 Diabetes

What Was Tested

In this phase 2 trial, researchers set out to test Dulaglutide for low blood pressure and orthostatic hypotension.

Placebo: subcutaneous (SC), once weekly (QW).

The registry classes the interventions as drug.

Who Took Part

The registry lists 755 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.

The full record lists 9 inclusion and 19 exclusion criteria; among the exclusions: myocardial infarction, stroke, or hospitalization for heart failure within 3 months prior to screening, or heart failure class iii or iv at screening; ongoing or history of frequent intermittent tachyarrhythmia; resting heart rate \<60 beats per minute (bpm) or \>100 bpm at screening.

How the Study Was Run

It was run as a randomized, parallel-group and quadruple-blind study.

Because people in this Dulaglutide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Groups ran in parallel: each of the low blood pressure and orthostatic hypotension participants stayed in one arm throughout.

Neither the low blood pressure and orthostatic hypotension participants nor the staff measuring them knew who was on Dulaglutide, so expectations could not easily colour the readings.

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

It started in 2010-06 with completion listed for 2011-09.

It ran at 76 sites in United States (42), Canada (11), Argentina (5), India (5), Czechia (4) and Puerto Rico (4).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change From Baseline to 16 Weeks in Mean 24-hour Systolic Blood Pressure (SBP) (time frame: Baseline, 16 weeks).

It also tracked 24 secondary outcomes, for example Change From Baseline to 26 Weeks in Mean 24-hour Systolic Blood Pressure (SBP), Change From Baseline to 16 and 26 Weeks in Mean 24-hour Diastolic Blood Pressure (DBP), Change From Baseline to 16 and 26 Weeks in Mean 24-Hour Heart Rate (HR), Change From Baseline to 16 and 26 Weeks in Mean 24-hour Pulse Pressure, Change From Baseline to 16 and 26 Weeks in Mean 24-hour Mean Arterial Pressure (MAP) and Change From Baseline to 16 and 26 Weeks in Mean Daytime, Nighttime, and Clinic Systolic Blood Pressure (SBP).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Dulaglutide in 755 people with low blood pressure and orthostatic hypotension.

With 755 participants it is a large trial for this field.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

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