A Study Comparing Exenatide With Basal Insulin in Achieving a Target HbA1c With Minimum Weight Gain in Type 2 Diabetes Patients

Plain-language guide to NCT00360334: phase 3 randomized trial of Exenatide and Insulin Glargine, 235 participants. Who took part, design and what was measured.

Key Facts

Registry ID: NCT00360334
Phase: phase 3
Status: completed
Start: 2006-06
Completion (planned or actual): 2008-04
Participants: 235 (actual)
Design: randomized, open label (everyone knows who gets what), treatment
Conditions studied: Type 2 Diabetes
Results posted: yes

What This Study Did, in Plain Language

What Was Tested

This registered phase 3 trial tested Exenatide and Insulin Glargine.

This is a phase 3 trial designed to compare the effects of twice daily exenatide plus oral antidiabetic agents (OADs) and once-daily insulin glargine plus OADs with respect to glycemic control, as measured by hemoglobin A1c, with minimum weight gain, in patients with uncontrolled type 2 diabetes on OADs.

It had two arms (groups): 1 (experimental) and 2 (active comparator).

The registry classes the interventions as drug.

Who Took Part

235 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: Diagnosed with type 2 diabetes.

The full record lists 4 inclusion and 4 exclusion criteria.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

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.

Nothing was hidden in this open-label Exenatide study: the participants and staff both knew the treatment.

It started in 2006-06 with completion listed for 2008-04.

It ran at 31 sites in United Kingdom (31).

Its stated primary purpose is treatment.

What Was Measured

It also tracked 27 secondary outcomes, for example Change in Fasting Serum Glucose, Change in 7 Point Self Monitored Blood Glucose Profile, Change in Body Mass Index (BMI), Change in Waist Circumference, Change in Waist-to-hip Ratio and Change in Body Weight.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Exenatide and Insulin Glargine in 235 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 and the Insulin Glargine compound page, all human trials.

Our Notes on the Compounds

Exenatide: A 39-amino-acid GLP-1 receptor agonist first identified in Gila monster venom; sold as Byetta and Bydureon for type 2 diabetes.

Insulin Glargine: A long-acting insulin analog given once daily; brands include Lantus, Toujeo, Basaglar and Semglee.

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.