Effects of Exenatide Long-Acting Release on Glucose Control and Safety in Subjects With Type 2 Diabetes Mellitus(DURATION - 1)

What Was Tested

This registered phase 3 trial tested Exenatide.

A Randomized, Open-Label, Multicenter, Comparator-Controlled Study to Examine the Effects of Exenatide Long-Acting Release (LAR) on Glucose Control (HbA1c) and Safety in Subjects with Type 2 Diabetes Mellitus Managed with Diet Modification and Exercise and/or Oral Antidiabetic Medications.

It had two arms (groups): Exenatide Once Weekly (experimental) and Exenatide Twice Daily (active comparator).

Subcutaneous injection (SC), once a week of long acting release (LAR) exenatide.

The registry classes the interventions as drug.

More on the Plan

This trial is designed to examine the effect of exenatide once weekly compared to exenatide twice daily on glucose control and safety in subjects for at least 30 weeks.

The study is also designed to examine glucose control during the transition from exenatide twice daily for 30 weeks to exenatide once weekly.

Who Took Part

Enrollment: 303 actual participants took part.

It was open to people of any sex aged from 16 years with no upper age limit.

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

Examples of who could join: Body mass index (BMI) of 25 kg/m2 to 45 kg/m2, inclusive, at screening. (For sub-study) Currently participating in open ended assessment period of main study 2993 LAR105.

The full record lists 4 inclusion and 10 exclusion criteria; among the exclusions: has been previously exposed to exenatide (byetta®), exenatide lar, or any glucagon-like peptide-1 (glp-1) analog; received any investigational drug or has participated in any type of clinical trial within 30 days prior to screening; has been treated, is currently treated, or is expected to require or undergo treatment with any of the following excluded medications:.

How the Study Was Run

The set-up was 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.

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

It started in 2006-04 with completion listed for 2008-07.

It ran at 25 sites in United States (24) and Canada (1).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change in HbA1c From Baseline to Week 30 (time frame: Day -3, Week 30).

It also tracked 24 secondary outcomes, for example Change in HbA1c From Baseline to Week 364, Exenatide LAR Steady State Concentration From Week 29 to Week 30, Change in 2 Hours (2h) Postprandial Glucose From Baseline to Week 14, Change in Body Weight From Baseline to Week 30, Change in Body Weight From Baseline to Week 364 and Change in Fasting Plasma Glucose From Baseline to Week 30.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Exenatide in 303 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, all human trials.