Effect of Exenatide Monotherapy on Glucose Control in Subjects With Type 2 Diabetes Mellitus

What Was Tested

The trial (phase 2) is built around Exenatide.

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

The registry classes the interventions as drug.

Who Took Part

Enrollment: 99 actual participants took part.

It was open to people of any sex aged from 18 years up to 75 years.

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

Examples of who could join: Subject has type 2 diabetes mellitus treated with diet and exercise modification alone or in combination with one oral antidiabetic agent for no longer than 4 years.

The full record lists 1 inclusion and 2 exclusion criteria.

How the Study Was Run

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

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.

As a double-blind Exenatide study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant and investigator.

It started in 2003-09 with completion listed for 2004-01.

It ran at 23 sites in United States (23).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change in HbA1c (glycosylated hemoglobin) from Baseline to Day 28 (time frame: Baseline, Day 28).

It also tracked 4 secondary outcomes, for example Change in serum fructosamine concentration from Baseline to Day 14 and to Day 28, Change in body weight from Baseline to Day 14 and to Day 28, Change in fasting plasma glucose concentration from Baseline to Day 14 and to Day 28 and Change in postprandial blood glucose concentrations from Baseline to Day 28.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Exenatide in 99 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Exenatide compound page, all human trials.