Safety and Efficacy of Exenatide Once Weekly Injection Versus Metformin, Dipeptidyl Peptidase-4 Inhibitor, or Thiazolidinedione as Monotherapy in Drug-Naive Patients With Type 2 Diabetes (DURATION-4)

What Was Tested

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

It had four arms (groups): Exenatide Once Weekly (experimental), Metformin (active comparator), Sitagliptin (active comparator) and Pioglitazone (active comparator).

The registry classes the interventions as drug.

Who Took Part

The registry lists 820 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: Have type 2 diabetes and are treated with diet and exercise alone. At least 18 years of age. Body mass index (BMI) of 23 kg/m2 to 45 kg/m2, inclusive.

The full record lists 5 inclusion and 12 exclusion criteria; among the exclusions: have a history of renal transplantation or are currently receiving renal dialysis; have history of severe gi disorder (e.g., gastroparesis); have a history of acute or chronic pancreatitis.

How the Study Was Run

Design: randomized, parallel-group and double-blind.

The participants were allocated by chance, so the Exenatide group and the comparison group should start out alike.

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

Blinding on both sides kept the participants and researchers unaware of who received Exenatide.

Those kept unaware of assignments: participant and investigator.

It started in 2008-11 with completion listed for 2010-07.

It ran at 106 sites in United States (18), Canada (9), Brazil (8), United Kingdom (8), India (7) and Russia (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: Baseline, Week 26).

It also tracked 9 secondary outcomes, for example Change in Fasting Serum Glucose (FSG) From Baseline to Week 26, Change in Body Weight From Baseline to Week 26, Change in Fasting Total Cholesterol (TC) From Baseline to Week 26, Change in Fasting High-Density Lipoprotein (HDL) From Baseline to Week 26, Ratio of Fasting Triglycerides at Week 26 to Baseline and Assessment on Event Rate of Treatment-emergent Major Hypoglycemic Events.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Exenatide in 820 people.

With 820 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.