Evaluation of Exenatide in Patients With Diabetic Neuropathy

What Was Tested

The trial (not phased) is built around Exenatide and Insulin Glargine.

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

Subjects will take exenatide by subcutaneous injection twice daily for 18 months.

Subjects will take 1 daily injection of insulin glargine for 18 months.

The registry classes the interventions as drug.

More on the Plan

This study will look at the effects of the medication exenatide on peripheral neuropathy in people with type 2 diabetes.

Exenatide (trade name, BYETTA®) is an injectable medication used by people with type 2 diabetes to control blood sugar.

Peripheral neuropathy is a complication of diabetes that can cause symptoms such as numbness, tingling or burning sensations in the feet and hands.

In this study, about half of the participants will take exenatide by injection twice daily and the other half will take insulin glargine (Lantus®) by injection once daily.

Who Took Part

46 actual participants took part.

It was open to people of any sex aged from 18 years up to 70 years.

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

Examples of who could join: Type 2 diabetes treated with one or more oral agents. Presence of diabetic peripheral neuropathy. Age between 18 and 70 years. No risk factors or other causes of neuropathy. Willingness and capacity to sign the Institutional Review Board approved consent form and cooperate with the medical procedures for study duration.

The full record lists 7 inclusion and 9 exclusion criteria; among the exclusions: nursing mothers or pregnant women; A history of previous kidney, pancreas or cardiac transplantation; participation in an experimental medication trial within 3 months of starting the study.

How the Study Was Run

Design: randomized, parallel-group and open-label.

The participants were allocated by chance, so the Exenatide group and the comparison group should start out alike.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Everyone knew when Exenatide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2008-06 with completion listed for 2014-05.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Confirmed Clinical Neuropathy (CCN) (time frame: 18 Months).

It also tracked 2 secondary outcomes, for example Cardiac Autonomic Neuropathy (CAN) and Cardiac Autonomic Neuropathy.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Exenatide and Insulin Glargine in 46 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 and the Insulin Glargine compound page, all human trials.