Effect of AC2993 Compared With Insulin Glargine in Patients With Type 2 Diabetes Also Using Combination Therapy With Sulfonylurea and Metformin

What Was Tested

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

This is a multicenter, comparator-controlled, open-label, randomized, two-arm, parallel trial to compare the effect of exenatide twice daily and insulin glargine on glycemic control, as measured by hemoglobin A1c (HbA1c).

It had two arms (groups): Exenatide Arm (experimental) and Insulin Glargine Arm (active comparator).

Subcutaneous injection, once daily; forced titration to target blood glucose level.

The registry classes the interventions as drug.

Who Took Part

The registry lists 551 actual participants took part.

It was open to people of any sex aged from 30 years up to 75 years.

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

Examples of who could join: Female patients are not breastfeeding, and female patients of childbearing potential (not surgically sterilized and between menarche and 1-year postmenopause).

The full record lists 4 inclusion and 16 exclusion criteria; among the exclusions: patients are investigator site personnel directly affiliated with the study, or are immediate family of investigator site personnel directly affiliated with the study; patients have participated in this study previously or any other study using ac2993 or glp-1 analogs; patients have had greater than three episodes of severe hypoglycemia within 6 months prior to screening.

How the Study Was Run

It was run as a randomized, parallel-group and open-label 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.

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

Being open-label, the Exenatide study did not mask who received what.

It started in 2003-06 with completion listed for 2008-07.

It ran at 91 sites in United States (21), Australia (10), Germany (8), Poland (8), Belgium (6) and Puerto Rico (6).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change in Glycosylated Hemoglobin (HbA1c) (time frame: Baseline, week 26).

It also tracked 6 secondary outcomes, for example Change in Body Weight, Change in Fasting Serum Glucose, Change in 7-point Self-monitored Blood Glucose (SMBG) Profile, Percentage of Patients With Hypoglycemic Events and Change in Rate of Hypoglycemic Events.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Exenatide and Insulin Glargine in 551 people.

With 551 participants it is a large trial for this field.

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.