A Study of the Glucodynamic Effects of Dulaglutide (LY2189265) in Japanese Participants With Type 2 Diabetes

What Was Tested

This registered phase 4 trial tested Dulaglutide.

The purpose of this study is to evaluate the glucodynamic effects of dulaglutide in Japanese participants with type 2 diabetes mellitus.

It had two arms (groups): Dulaglutide, Placebo (experimental) and Placebo, Dulaglutide (experimental).

The registry classes the interventions as drug.

Who Took Part

The registry lists 12 actual participants took part.

It was open to people of any sex aged from 20 years up to 75 years.

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

The full record lists 4 inclusion and 7 exclusion criteria; among the exclusions: have known allergies to dulaglutide, or other glucagon-like peptide-1 (glp-1) receptor agonists; have acute or chronic hepatitis, signs and symptoms of any other liver disease; have a history of chronic pancreatitis or acute idiopathic pancreatitis, or were diagnosed with any type of acute pancreatitis.

How the Study Was Run

The set-up was randomized, crossover and single-blind.

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.

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

Only one side, usually the participants, was kept unaware of whether Dulaglutide was given.

Those kept unaware of assignments: participant.

It started in 2017-10-28 with completion listed for 2018-02-28.

It ran at 1 site in Japan.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change From Baseline in Glucose Area Under the Concentration Versus Time Curve From Time Zero to 4 Hours (AUC[0-4h]) (time frame: Baseline, 4 Weeks).

It also tracked 7 secondary outcomes, for example Change From Baseline in Fasting Blood Glucose, Change From Baseline in Postprandial Blood Glucose, Change From Baseline in Insulin Area Under the Concentration Versus Time Curve From Time Zero to 4 Hours (AUC [0-4h]), Change From Baseline in C-Peptide Area Under the Concentration Versus Time Curve From Time Zero to 4 Hours (AUC [0-4h]), Change From Baseline in Glucagon Area Under the Concentration Versus Time Curve From Time Zero to 4 Hours (AUC [0-4h]) and Change From Baseline in Triglyceride Area Under the Concentration Versus Time Curve From Time Zero to 4 Hours (AUC [0-4h]).

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Dulaglutide in 12 people.

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

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

More context: the Dulaglutide compound page, all human trials.