Efficacy Evaluation of Different Medication Combination in Type 2 Diabetes Treatment

What Was Tested

In this phase 4 trial, researchers set out to test Exenatide and Insulin Detemir.

Both medications are given by injection with a very small needle just below the surface of your skin (called subcutaneous injection).

The medication that you inject will be in addition to your oral medications.

It had three arms (groups): A Levemir (active comparator), B Exenatide (active comparator) and C Levemir+Exenatide (active comparator).

The registry classes the interventions as device and drug.

More on the Plan

Both drugs have been approved by the U.S.

Food and Drug Administration (FDA) for the treatment of type 2 diabetes.

The use of Levemir and Byetta in combination in this study, is investigational, meaning it is not approved by the FDA for this use.

Levemir is a long acting insulin that is usually taken once a day at bedtime and can last for up to 24 hours.

Who Took Part

Enrollment: 75 planned participants were the target.

It was open to people of any sex aged from 18 years up to 90 years.

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

Examples of who could join: A diagnosis of Type 2 DM for over six months. 18 years of age or older. Stable medical status (e.g., no myocardial infarction, stroke, major surgery, or major mental illness during the previous 6 months). Naïve to insulin (no insulin for more than 14 days during the previous 6 months and none within 60 days of beginning the study). BMI \< 40 kg/m2.

The full record lists 8 inclusion and 9 exclusion criteria; among the exclusions: A diagnosis of Type 2 DM for less than six months; pregnancy as determined by a serum ß hcg; an unstable medical status.

How the Study Was Run

Design: 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.

The Exenatide group and the comparison group ran side by side rather than switching.

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

It started in 2008-04 with completion listed for 2011-04.

It ran at 2 sites in United States (2).

Its stated primary purpose is treatment.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Exenatide and Insulin Detemir in 75 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 and the Insulin Detemir compound page, all human trials.