An Exploratory Study of the Effect of Treatment Interruption on Safety of Exenatide in Patients With Type 2 Diabetes

What Was Tested

The trial (phase 3) is built around Exenatide.

The primary purpose of this study is to assess the anti-exenatide-antibody response to exenatide re-exposure as measured by anti-exenatide antibodies and incidence of treatment-emergent allergy and hypersensitivity reactions following a period of treatment interruption, in patients previously exposed to exenatide.

It had two arms (groups): Exenatide:Treatment-Emergent Antibody Negative (experimental) and Exenatide:Treatment-Emergent Antibody Positive (experimental).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 58 actual participants took part.

It was open to people of any sex aged from 20 years with no upper age limit.

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

Examples of who could join: Diagnosed with type 2 diabetes. Have interrupted exenatide treatment for a period of at least 2 months.

The full record lists 4 inclusion and 6 exclusion criteria; among the exclusions: have previously completed or withdrawn from this study; have taken marketed exenatide (byetta) during the interim period between studies gwao, gwap, gwat, or gwba and the current study; used drugs for weight loss (for example, xenical® \[orlistat\], meridia® \[sibutramine\], acutrim® \[phenylpropanolamine\], accomplia® \[rimonabant\], or similar over-the-counter medications) within 3 months of screening.

How the Study Was Run

It was run as a non-randomized, parallel-group and open-label study.

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

Nothing was hidden in this open-label Exenatide study: the participants and staff both knew the treatment.

It started in 2007-08 with completion listed for 2008-04.

It ran at 13 sites in Canada (3), Hungary (3), Italy (3), South Korea (3) and Australia (1).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Treatment-emergent Antibody Status (Maximum Titer Level Experienced) (time frame: 24 weeks). Incidence of Potentially Immune-related Treatment-emergent Adverse Events (time frame: 24 weeks).

It also tracked 1 secondary outcome, for example Change in Hemoglobin A1c (HbA1c) From Baseline to Endpoint.

What This Means in Plain Language

Put simply, this is a phase 3, non-randomized trial of Exenatide in 58 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.