Exeantide in Type 2 Diabetes on Insulin

What Was Tested

The trial (phase 2) is built around Exenatide.

It had three arms (groups): one (experimental), one (experimental) and placebo (placebo comparator).

Placebo.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 24 actual participants took part.

It was open to people of any sex aged from 20 years up to 75 years.

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

Examples of who could join: Males or females 20-75 years of age inclusive. Type 2 diabetes. On insulin therapy. BMI ≥ 30 kg/m2.

The full record lists 6 inclusion and 10 exclusion criteria; among the exclusions: coronary event or procedure (myocardial infarction, unstable angina, coronary artery bypass, surgery or coronary angioplasty) in the previous four weeks; hepatic disease (abnormal lft's); use of dpp4 inhibitors.

How the Study Was Run

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

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.

In this single-blind Exenatide study one party knew the assignments and the other did not.

Those kept unaware of assignments: participant.

It started in 2008-04 with completion listed for 2011-11.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Fasting Insulin (time frame: after 24 hours fast at baseline and 12 weeks).

It also tracked 3 secondary outcomes, for example Weight, HbA1c and Intranuclear NFκB Binding Activity.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Exenatide in 24 people.

Its size is small, so on its own it can only give an early look.

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.