Effect of Pioglitazone and Exenatide on Body Weight and Beta Cell Function

What Was Tested

The trial (phase 4) is built around Exenatide.

It had three arms (groups): Pioglitazone (active comparator), Exenatide (experimental) and Drug Pioglitazone and Drug Exentatide (experimental).

Pioglitazone: 15 Patients will be randomized to Pioglitazone only arm.

Exenatide: 15 subjects will be randomized to receive Exenatide.

Pioglitazone and Exenatide: 15 subjects will be randomized to Pioglitazone and Exenatide.

The registry classes the interventions as drug.

More on the Plan

In the present study, the researchers will perform a more definitive assessment of beta cell function in TZD-treated diabetic patients by measuring the maximal insulin secretory capacity using a maximal hyperglycemic stimulus combined with an intravenous arginine stimulus.

Exenatide (Byetta) is 39 amino acid peptide which exhibits biological actions similar to GLP-1.

In this proposal the researchers will examine the effect of combination therapy with pioglitazone plus exenatide on body weight, fat topography, beta cell function, glycemic control, and plasma lipid levels in subjects with type 2 diabetes mellitus compared to monotherapy with each agent separately.

NGT and IGT subjects will participate only in a OGTT and a Hyperglycemic clamp- they will not receive any medication.

Who Took Part

The registry lists 43 actual participants took part.

It was open to people of any sex aged from 18 years up to 65 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Patients must have the following laboratory values:. Body weight must be stable (± 3-4 pounds) over the three months prior to study.

The full record lists 6 inclusion and 4 exclusion criteria; among the exclusions: patients must not have type 1 diabetes; patients must not have received a thiazolidinedione or insulin for more than one week during the year prior to randomization.

How the Study Was Run

The set-up was randomized, parallel-group and single-blind.

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 2007-06 with completion listed for 2010-07.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Effect of Pioglitazone, Exenatide and Combined Pioglitazone and Exenatide on Body Weight (time frame: baseline and 6 months). HbA1c (time frame: baseline and 6 months).

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Exenatide in 43 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.