Study to Evaluate Safety and PK/PD of DA-3091 in Healthy Male Subjects

What Was Tested

This registered phase 1 trial tested Exenatide.

It had two arms (groups): DA-3091 (experimental) and Placebo of DA-3091 (placebo comparator).

SR-exenatide.

Placebo.

The registry classes the interventions as drug.

More on the Plan

To meet the clinical objectives, the researchers are using a two-part approach.

After completion of part I study, the researchers are reporting data about safety to IDMC.

The ratio of DA-3091 and placebo is 3:1.

Who Took Part

Enrollment: 31 actual participants took part.

It was open to men only aged from 20 years up to 45 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Age : 20 \~ 45 years old.

The full record lists 4 inclusion and 7 exclusion criteria; among the exclusions: acute or chronic pancreatitis; history of administration of exenatide; disorder of blood pressure.

How the Study Was Run

The set-up was randomized, parallel-group and quadruple-blind.

Because people in this Exenatide 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 participants stayed in one arm throughout.

Neither the participants nor the staff measuring them knew who was on Exenatide, so expectations could not easily colour the readings.

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

It started in 2010-07 with completion listed for 2012-04.

It ran at 1 site in South Korea.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Assessment of safety (time frame: 84 days).

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Exenatide in 31 people.

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 Exenatide compound page, all human trials.