Effect of Exenatide, Sitagliptin or Glimepiride on Functional ß -Cell Mass

What Was Tested

This registered not phased trial tested Exenatide.

This study evaluates exenatide, sitagliptin, and glimepiride for the treatment of high blood sugar in patients with impaired fasting glucose or early type 2 diabetes.

It had three arms (groups): Exenatide (experimental), Sitagliptin (experimental) and Glimepiride (active comparator).

The registry classes the interventions as drug.

More on the Plan

The incidence of type 2 diabetes (T2D) has reached epidemic proportions throughout the world.

T2D ultimately results from an inadequate mass of functional beta-cells, where insufficient beta-cell compensation for insulin resistance leads to the development of impaired glucose tolerance and eventually diabetes.

Strategies that might preserve or expand functional beta-cell mass in vivo would be expected to reverse the progressive deterioration in blood glucose control seen with diabetes.

Who Took Part

Enrollment: 47 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: Male and female patients age 18 to 70 years. Ability to provide written informed consent. Mentally stable and able to comply with the procedures of the study protocol. Female Patients: Agree to use adequate contraception if reproductively capable. Adequate contraception includes either a hormonal or barrier method, or surgical sterilization.

The full record lists 6 inclusion and 16 exclusion criteria; among the exclusions: diagnosis of type 1 diabetes; receiving insulin, exenatide (byetta®), or sitagliptin (januvia®) treatment or taking \> 2 oral anti-diabetogenic agents for the treatment of diabetes; BMI \> 44 kg/m2.

How the Study Was Run

Design: 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.

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

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

It started in 2008-10 with completion listed for 2012-11.

It ran at 3 sites in United States (3).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Effect on Functional Beta-cell Mass as Determined by Change in ß-cell Secretory Capacity at 6 Months (μU/ml) (time frame: Baseline and 6 months). Effect on Functional Beta-cell Mass as Determined by Change in ß-cell Secretory Capacity at 6 Months (pg/mL) (time frame: Baseline and 6 months).

It also tracked 3 secondary outcomes, for example Change in Acute Insulin Response to Arginine. (AIRarg) and Insulin Sensitivity at Baseline and 6 Months.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Exenatide in 47 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.