Durability of Combination Therapy With Exenatide/Pioglitazone/Metformin vs. Conventional Therapy in New Onset T2DM

What Was Tested

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

Multiple defects, e.g. impaired insulin secretion and impaired insulin action, contribute to the development of the disease.

It had two arms (groups): Triple Therapy (experimental) and conventional therapy (active comparator).

Sequential addition of metformin, glyburide and basal insulin.

The registry classes the interventions as drug.

More on the Plan

The first intervention is based on the novel concept of initiating therapy at the time of diagnosis with combination therapy using agents that correct specific pathophysiologic defects that are characteristic of T2DM (insulin resistance and beta cell failure).

Who Took Part

The registry lists 318 actual participants took part.

It was open to people of any sex aged from 18 years up to 80 years.

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

Examples of who could join: Above 18 years of age,. Drug naive, or have been on metformin less than 3 months.

The full record lists 3 inclusion and 1 exclusion criteria.

How the Study Was Run

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

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

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

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 2009-01 with completion listed for 2023-02-03.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: HbA1c Level (time frame: at the end of the study (3 years)).

It also tracked 2 secondary outcomes, for example Treatment Failure and Percentage of Patients With Reported Hypoglycemic Events.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Exenatide and Insulin Glargine in 318 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.