A Comparison of Adding Exenatide With Switching to Exenatide in Patients With Type 2 Diabetes Experiencing Inadequate Glycemic Control With Sitagliptin Plus Metformin

What Was Tested

In this phase 4 trial, researchers set out to test Exenatide.

It had two arms (groups): 1 (experimental) and 2 (placebo comparator).

The registry classes the interventions as drug.

Who Took Part

The registry lists 255 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: Present with type 2 diabetes. Have a body mass index (BMI) ≥20 kg/m2 and \<45 kg/m2.

The full record lists 6 inclusion and 14 exclusion criteria; among the exclusions: have previously completed or withdrawn from this study or any other study investigating exenatide; have a known allergy or hypersensitivity to exenatide, sitagliptin or excipients contained in exenatide or sitagliptin; used drugs for weight loss (for example, orlistat, sibutramine, phenylpropanolamine, or similar over-the-counter medications) within 1 month of screening.

How the Study Was Run

It was run as a randomized, parallel-group and double-blind study.

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.

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 and investigator.

It started in 2009-03 with completion listed for 2010-04.

It ran at 36 sites in Germany (15), India (5), Mexico (5), South Korea (4), Australia (3) and Argentina (2).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change in HbA1c (Percent) (time frame: Baseline to 20 Weeks).

It also tracked 16 secondary outcomes, for example Change in FSG (mmol/L), Change in Body Weight (kg), Change in Waist Circumference (cm), Waist-to-Hip Ratio, SMBG (mmol/L) and Change in Triglycerides (mmol/L).

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Exenatide in 255 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.