A Study to Evaluate the Glycemic Effects, Safety, and Tolerability of Exenatide Once Weekly in Subjects With Type 2 Diabetes Mellitus (DURATION-5)

What Was Tested

The trial (phase 3) is built around Exenatide.

This study will compare the effects of commercially manufactured exenatide once weekly and exenatide BID in subjects whose type 2 diabetes is managed with diet and exercise alone or with oral antidiabetic medications.

The study will examine glycemic control (as measured by HbA1C), safety, and tolerability.

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

The registry classes the interventions as drug.

Who Took Part

254 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: Has been diagnosed with type 2 diabetes mellitus. Has a body mass index (BMI) of 25 kg/m2 to 45 kg/m2, inclusive, at screening. Either is not treated with or has been on a stable treatment regimen with any of the following medications for a minimum of 2 months prior to screening:. Hormone replacement therapy (female subjects). Oral contraceptives (female subjects).

The full record lists 12 inclusion and 7 exclusion criteria; among the exclusions: has ever been exposed to exenatide (exenatide once weekly \[exenatide lar\], exenatide bid, byetta, or any other formulation) or any glucagon-like peptide-1 (glp-1) analog; has received any investigational drug within one month (or five half-lives of the investigational drug, whichever is greater) of screening; has been treated, is currently being treated, or is expected to require or undergo treatment with any of the following treatment excluded medications:.

How the Study Was Run

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

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

Groups ran in parallel: each of the participants stayed in one arm throughout.

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 2009-03 with completion listed for 2009-10.

It ran at 41 sites in United States (41).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change in HbA1c From Baseline to Week 24 (time frame: Day 1, Week 24).

It also tracked 12 secondary outcomes, for example Change in Fasting Plasma Glucose From Baseline to Week 24, Change in Body Weight From Baseline to Week 24, Change in Sitting Systolic Blood Pressure From Baseline to Week 24, Change in Sitting Diastolic Blood Pressure From Baseline to Week 24, Change in Total Cholesterol From Baseline to Week 24 and Change in High-density Lipoprotein (HDL) From Baseline to Week 24.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Exenatide in 254 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.