A Study to Examine the Efficacy, Safety and Tolerability, and Pharmacokinetics of Exenatide Once Monthly Suspension

What Was Tested

In this phase 2 trial, researchers set out to test Exenatide.

It had four arms (groups): Group A (active comparator), Group B (experimental), Group C (experimental) and Group D (experimental).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 121 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

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

Examples of who could join: Is at least 18 years old at study start. Has been diagnosed with type 2 diabetes mellitus.

The full record lists 5 inclusion and 15 exclusion criteria; among the exclusions: acute or chronic pancreatitis; personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia (men) type 2; active cardiovascular disease within 3 months of study start.

How the Study Was Run

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

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.

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

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

It started in 2010-05 with completion listed for 2010-12.

It ran at 2 sites in United States (2).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Mean Change in HbA1c From Baseline to End of Treatment (Week 20) - Evaluable Population (time frame: Baseline (Day 1) to 20 weeks).

It also tracked 11 secondary outcomes, for example Percentage of Participants Achieving HbA1c Target Values at Week 20 - Evaluable Population, Mean Change in Body Weight From Baseline to Week 20 - Evaluable Population, Mean Change in Fasting Glucose From Baseline to Week 20 - Evaluable Population, Mean Change From Baseline in Diastolic and Systolic Blood Pressure at Week 20 - Intent to Treat (ITT) Population, Mean Change From Baseline in Heart Rate at Week 20 - Intent to Treat (ITT) Population and Number of Participants With Injection Site Reaction Treatment Emergent Adverse Events - ITT Population.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Exenatide in 121 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.