A Study of Dose Titration of LY2189265 in Overweight Participants With Type 2 Diabetes Mellitus

What Was Tested

This registered phase 2 trial tested Dulaglutide.

The registry classes the interventions as drug.

Who Took Part

The registry lists 262 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: Type 2 Diabetes Mellitus \>3 months by history prior to entering the trial, based on disease diagnostic criteria from the American Diabetes Association (ADA 2007). Men or women 18 years of age or older. Women must have a negative pregnancy test and be willing to use birth control during study duration and one month post. Have a body mass index (BMI) between 27 and 40 kilograms/meter squared (kg/m\^2), inclusive.

The full record lists 5 inclusion and 5 exclusion criteria; among the exclusions: have known type 1 diabetes mellitus; have taken glucagon-like peptide-1 (glp-1) or any glp-1 analog drug (byetta).

How the Study Was Run

Design: randomized, parallel-group and triple-blind.

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

The Dulaglutide group and the comparison group ran side by side rather than switching.

Neither the 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 and investigator.

It started in 2008-04 with completion listed for 2009-01.

It ran at 34 sites in United States (31) and Puerto Rico (3).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change From Baseline in Glycosylated Hemoglobin (HbA1c) in Overweight and Obese Participants With Type 2 Diabetes Mellitus (time frame: Baseline, 16 weeks).

It also tracked 15 secondary outcomes, for example Change From Baseline in Fasting Blood Glucose, Meal Test Glucose Excursion (Change in Blood Glucose to Test Meal), Change From Baseline in Daily Mean Blood Glucose Values From the 8-point Self Monitored Blood Glucose (SMBG) Profiles, Change From Baseline in Body Weight, Change From Baseline in Waist Circumference and Nausea and Dyspepsia Measured by Visual Analog Scale.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Dulaglutide in 262 people.

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.