How Glargine Insulin, Oral Diabetes Medications and Exenatide May Improve Blood Sugar Control and Weight Gain in Type 2 Diabetics

What Was Tested

The trial (phase 4) is built around Exenatide.

The main study will last 32 weeks.

However, all participants completing 32 weeks will be invited to continue for another 24 weeks taking the insulin and oral medication and exenatide treatment.

It had two arms (groups): 1 (active comparator) and 2 (placebo comparator).

Participants will receive exenatide as part of their diabetes treatment.

Participants will receive placebo rather than exenatide as part of their diabetes treatment.

The registry classes the interventions as drug.

Who Took Part

41 actual participants took part.

It was open to people of any sex aged from 30 years up to 70 years.

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

Examples of who could join: Male or female patients with type 2 diabetes. Age range 30 to 70 years. Body mass index 25-45 kg/m2.

The full record lists 6 inclusion and 17 exclusion criteria; among the exclusions: use of more than two antihyperglycemic agents within the last 3 months; use of more than one daily injection of any kind of insulin in the last 3 months; positive anti-gad antibody (test required in screening).

How the Study Was Run

Design: randomized, single-group and triple-blind.

Because people in this Exenatide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Neither the participants nor the staff measuring them knew who was on Exenatide, so expectations could not easily colour the readings.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

Those kept unaware of assignments: participant, care provider and investigator.

It started in 2007-03 with completion listed for 2009-10.

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

Its stated primary purpose is treatment.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Exenatide in 41 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.