A Study of Taspoglutide Versus Exenatide for the Treatment of Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin, Thiazolidinedione or a Combination of Both.

What Was Tested

In this phase 3 trial, researchers set out to test Exenatide.

The anticipated time on study treatment is 3+ years, and the target sample size is \>500 individuals.

It had three arms (groups): exenatide (active comparator), one (experimental) and one (experimental).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 1189 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: Adult patients, 18-75 years of age;. Type 2 diabetes receiving metformin and/or pioglitazone or rosiglitazone for at least 12 weeks;. BMI \>=25kg/m2 (\>23kg/m2 for Asians) and \<=45kg/m2 at screening;.

The full record lists 5 inclusion and 8 exclusion criteria; among the exclusions: history of type 1 diabetes, diabetes resulting from pancreatic injury or secondary forms of diabetes;; history of acute metabolic diabetic complications within the previous 6 months;; known proliferative diabetic retinopathy;.

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 2008-07 with completion listed for 2011-03.

It ran at 216 sites in United States (87), Russia (24), Germany (18), Mexico (9), Israel (8) and Brazil (7).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change in HbA1c (time frame: 24 weeks).

It also tracked 4 secondary outcomes, for example Fasting body weight, Relative change in glucose, insulin, C-peptide and glucagon values during a meal tolerance test in a subset of patients and Beta cell function (proinsulin/insulin ratio).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Exenatide in 1189 people.

With 1189 participants it is a large trial for this field.

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.