Comparing Exenatide and Insulin Glargine in Type 2 Diabetes Patients for Whom Insulin is the Next Appropriate Therapy

What Was Tested

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

It had two arms (groups): exenatide/insulin glargine (experimental) and Insulin glargine/exenatide (experimental).

Arm that first receives exenatide, then crosses over to insulin glargine.

Arm that first receives insulin glargine, then crosses over to exenatide.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 138 actual participants took part.

It was open to people of any sex aged from 30 years with no upper age limit.

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

Examples of who could join: Insulin therapy should be the next appropriate step of diabetes treatment. Body Mass Index (BMI) \>25 kg/m2 and \<40 kg/m2.

The full record lists 4 inclusion and 2 exclusion criteria; among the exclusions: patient previously in a study involving exenatide or glucagon-like peptide-1 analogs; treated with insulin, thiazolidinediones, alpha-glucosidase inhibitors, or meglitinides within 3 months prior to screening.

How the Study Was Run

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

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

In the crossover set-up each of the participants took both Exenatide and the comparison in turn, acting as their own control.

Everyone knew when Exenatide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2004-09 with completion listed for 2005-08.

It ran at 26 sites in Italy (6), Australia (5), Hungary (5), Mexico (4), Greece (3) and Poland (3).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change in HbA1c (glycosylated hemoglobin) from the baseline of the first period (16-weeks of exenatide or insulin) to the end of each 16-week period (time frame: Baseline, Week 16, Week 32).

It also tracked 1 secondary outcome, for example Change in patient-reported outcomes from Baseline to the end of each 16-week period.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Exenatide and Insulin Glargine in 138 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 and the Insulin Glargine compound page, all human trials.