A Study to Compare the Glycemic Effects, Safety, and Tolerability of Exenatide Once Weekly to Those of Sitagliptin and Pioglitazone,in Subjects With Type 2 Diabetes Treated With Metformin (DURATION - 2)

What Was Tested

The trial (phase 3) is built around Exenatide.

The safety and tolerability of the three treatment regimens will also be compared.

It had three arms (groups): 1 (experimental), 2 (active comparator) and 3 (active comparator).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 514 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: Has been diagnosed with type 2 diabetes mellitus. Has a body mass index (BMI)of 25 kg/m2 to 45 kg/m2, inclusive, at study start. Has been on a stable treatment regimen of metformin for a minimum of 2 months prior to study start. Either is not treated with or has been on a stable treatment regimen with any of the following medications for a minimum of 2 months prior to study start:. Hormone replacement therapy (female subjects).

The full record lists 12 inclusion and 10 exclusion criteria; among the exclusions: has been previously exposed to exenatide once weekly; has donated blood within 60 days of study start or is planning to donate blood during the study; currently being treated, or is expected to require or undergo treatment with any of the following treatment-excluded medications:.

How the Study Was Run

The set-up was randomized, parallel-group and double-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.

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

Those kept unaware of assignments: participant and investigator.

It started in 2008-01 with completion listed for 2009-02.

It ran at 62 sites in United States (51), Mexico (6) and India (5).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change in HbA1c From Baseline to Week 26 (time frame: Day 1, Week 26).

It also tracked 11 secondary outcomes, for example Change in Body Weight From Baseline to Week 26, Change in Fasting Plasma Glucose From Baseline to Week 26, Change in Systolic Blood Pressure From Baseline to Week 26, Change in Diastolic Blood Pressure From Baseline to Week 26, Change in Fasting Total Cholesterol From Baseline to Week 26 and Change in Fasting High-density Lipoprotein (HDL) From Baseline to Week 26.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Exenatide in 514 people.

With 514 participants it is a large trial for this field.

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.