A Study to Determine the Efficacy and Safety of Albiglutide as Compared With Liraglutide.

What Was Tested

In this phase 3 trial, researchers set out to test Liraglutide.

It had two arms (groups): albiglutide (experimental) and liraglutide (active comparator).

Weekly albiglutide subcutaneous injection.

The registry classes the interventions as biological and drug.

More on the Plan

Subjects with a historical diagnosis of type 2 diabetes mellitus and whose glycemia is inadequately controlled on their current regimen of metformin, thiazolidinedione, sulfonylurea, or any combination of these oral antidiabetics will be recruited into the study.

Who Took Part

841 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: Diagnosis of type 2 diabetes mellitus and experiencing inadequate glycemic control on their current regimen of metformin, TZD, SU, or any combination of these oral antidiabetic medications. BMI \>/=20kg/m2 and \</=45 kg/m2. Female subjects of childbearing potential must be practicing adequate contraception.

The full record lists 5 inclusion and 15 exclusion criteria; among the exclusions: history of cancer; history of treated diabetic gastroparesis; current biliary disease or history of pancreatitis.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

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

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

Being open-label, the Liraglutide study did not mask who received what.

It started in 2010-05 with completion listed for 2011-09.

It ran at 173 sites in United States (129), Australia (9), Peru (7), South Korea (7), Philippines (6) and Spain (6).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Mean Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 32 (time frame: Baseline and Week 32).

It also tracked 6 secondary outcomes, for example Mean Change From Baseline in HbA1c at Weeks 4, 6, 12, 18 and 26, Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 32, Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Weeks 1, 2, 3, 4, 6, 12, 18 and 26, Time to Hyperglycemia Rescue at Week 32 and Mean Change From Baseline in Body Weight at Week 32.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Liraglutide in 841 people.

With 841 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 Liraglutide compound page, all human trials.