Out-Patient Study in Patients With Type 2 Diabetes Mellitus Who Are Taking no Diabetes Medication or Metformin Only

What Was Tested

In this phase 2 trial, researchers set out to test Exenatide.

This study is a placebo-controlled study in patients with Type 2 Diabetes Mellitus who are either taking no diabetes medication or who are taking metformin only.

As a comparison, some subjects will receive exenatide instead of Albiglutide (GSK716155).

The registry classes the interventions as drug.

Who Took Part

361 actual participants took part.

It was open to people of any sex aged from 18 years up to 75 years.

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

Examples of who could join: Is male or female 18 to 75 years of age, inclusive, at screening. Has body mass index ≥20 and ≤40 kg/m². If subject is a smoker, must be able to abstain while in clinic at each visit. Signs and dates informed consent before any study-related procedures are performed.

The full record lists 8 inclusion and 19 exclusion criteria; among the exclusions: has qualitative changes in lifestyle that, in the opinion of the investigator, would affect the subject's weight or disease status; if female, is currently lactating, pregnant, or actively trying to become pregnant; has history of pancreatitis within five years prior to randomization.

How the Study Was Run

It was run as a randomized, parallel-group and double-blind study.

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.

As a double-blind Exenatide study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant and investigator.

It started in 2007-04 with completion listed for 2008-05.

It ran at 163 sites in United States (158), Chile (4) and Dominican Republic (1).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 16 (time frame: Baseline and Week 16).

It also tracked 17 secondary outcomes, for example Change From Baseline in HbA1c at Weeks 4, 5, 7, 8, 9, 12, 15, and 16, Change From Baseline in Waist Circumference at Week 16, Change From Baseline in Body Weight at Week 16, Percent Change From Baseline in Body Weight at Week 16, Change From Baseline in Fasting Plasma Glucose (FPG) at Weeks 4, 5, 7, 8, 9, 12, 15, and 16 and Change From Baseline in Fasting Fructosamine at Weeks 5, 8, 12, and 16.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Exenatide in 361 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.