Study of the Safety of Substituting Exenatide for Insulin in Patients Using Insulin and Oral Antidiabetic Agents

What Was Tested

This registered phase 2 trial tested Exenatide and Insulin (regular human).

This study will look at the safety of substituting exenatide for insulin in patients with type 2 diabetes who are currently taking insulin and oral antidiabetic agent(s).

It had two arms (groups): Exenatide (experimental) and Insulin (active comparator).

The subjects will discontinue their insulin and substitute it with exenatide. Subjects will remain on their existing oral diabetic therapy.

The subjects will remain on their current insulin therapy. Subjects will also remain on their existing oral diabetic therapy.

The registry classes the interventions as drug.

More on the Plan

This is an exploratory, multicenter, open-label, 2-arm, parallel trial.

Approximately 30 patients with type 2 diabetes, currently on a sulfonylurea, or meglitinide and/or metformin and insulin therapy, will be randomized to discontinue insulin and substitute it with exenatide or remain on their current diabetes therapy regimen.

All patients will continue their current diet and exercise regimen during the study.

Who Took Part

Enrollment: 49 actual participants took part.

It was open to people of any sex aged from 35 years up to 70 years.

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

Examples of who could join: Patients have been treated with insulin for \>=3 months up to 12 years. Body mass index (BMI) between 27 kg/m2 and 40 kg/m2.

The full record lists 3 inclusion and 2 exclusion criteria; among the exclusions: patients previously received exenatide or glp-1 analogs; patients have been treated for greater than 2 weeks with thiazolidinediones or alpha-glucosidase inhibitors within 3 months prior to screening.

How the Study Was Run

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

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.

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

It started in 2004-02 with completion listed for 2005-08.

It ran at 5 sites in United States (5).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change in HbA1c (glycosylated hemoglobin) from Baseline to Week 16 (time frame: Baseline, Week 16).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Exenatide and Insulin (regular human) in 49 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Exenatide compound page and the Insulin (regular human) compound page, all human trials.