Study to Evaluate the Effect of BYDUREON on 24-hour Glucose Control in Metformin Treated Patients With Type 2 Diabetes.

What Was Tested

This registered phase 4 trial tested Exenatide.

It had two arms (groups): Bydureon (experimental) and Placebo (placebo comparator).

Once weekly injected exenatide.

Placebo comparator.

The registry classes the interventions as drug.

Who Took Part

239 actual participants took part.

It was open to people of any sex aged from 18 years up to 75 years.

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

Examples of who could join: Body mass index (BMI) \< or = to 45 kg/m2.

The full record lists 3 inclusion and 5 exclusion criteria; among the exclusions: history of taking antihyperglycemic therapy other than metformin or metformin extended release (xr) during the 8 weeks prior to screening; history of taking a dipeptidyl peptidase-4 (dpp-4) inhibitor or pramlintide during 12 weeks prior to screening; history of potent, inhaled or intrapulmonary steroids 3 months prior to screening or during the study.

How the Study Was Run

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

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

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

Blinding on both sides kept the participants and researchers unaware of who received Exenatide.

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

It started in 2014-12 with completion listed for 2015-08.

It ran at 29 sites in United States (29).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change in 24-hour Mean Weighted Glucose (time frame: Day 27/28).

It also tracked 5 secondary outcomes, for example Change From Baseline (Day1) to Day 70 and Day 22 in FPG, Change From Baseline (Day -1) to Day 64 and Day 22 in 2- Hour Mean Weighted PPG (After the Breakfast Meal), Average of Change in 24-hour Mean Weighted Glucose From Baseline to Week 4 and Baseline to Week 10 and Change in HbA1c From Baseline to Day 22 and Baseline to Day 70.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Exenatide in 239 people.

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

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