Evaluation of the Effect on Glucose Control and Safety of AC2993 in Patients With Type 2 Diabetes Treated With Metformin, Sulfonylurea, or Metformin and Sulfonylurea Combination

What Was Tested

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

This multi-center, open-label study is designed to examine the effects on long-term glucose control and safety of AC2993 in patients with type 2 diabetes treated with metformin, sulfonylurea, or metformin and sulfonylurea combination.

It had 1 arm (groups): AC2993 (experimental).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 155 actual participants took part.

It was open to people of any sex aged from 20 years up to 75 years.

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

Examples of who could join: Subjects with type 2 diabetes. Treated for at least 3 months prior to screening either with metformin, sulfonylurea, or metformin and sulfonylurea combination. BMI 25-45 kg/m\^2.

The full record lists 4 inclusion and 3 exclusion criteria; among the exclusions: treated with other oral anti-diabetic agents other than metformin and sulfonylureas within 3 months of screening; patients previously treated with ac2993; patients presently treated with insulin.

How the Study Was Run

It was run as a non-randomized, single-group and open-label study.

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.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2002-08 with completion listed for 2005-09.

It ran at 3 sites in Hungary (3).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change in HbA1c (glycosylated hemoglobin) from Baseline to Week 24, Week 52, and to each intermediate visit (time frame: Baseline, and Weeks 1, 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52). Change in concentrations of fasting plasma glucose and lipids from Baseline Visit 2 (Day 1) to Week 24, to Week 52, and to each intermediate visit (time frame: Baseline, and Weeks 1, 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52).

What This Means in Plain Language

Put simply, this is a phase 3, non-randomized trial of Exenatide in 155 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Exenatide compound page, all human trials.