Glycemic Optimization Treatment Study

What Was Tested

In this phase 4 trial, researchers set out to test Insulin Glargine.

The registry classes the interventions as drug.

Who Took Part

The registry lists 5062 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: Subjects must give their signed informed consent. Diagnosis of Type 2 DM for at least 6 months. Males and females greater than or equal to 18 years of age. Current (last 2 months) diabetes therapy with oral anti-hyperglycemia agents only. Able to understand and willing to comply with procedures required by the protocol and have access to a phone.

The full record lists 10 inclusion and 12 exclusion criteria; among the exclusions: cardiac status new york heart association (nyha) iii-iv (appendix a); for subjects on thiazolidinediones, the inability or unwillingness to discontinue these medications and to remain off them through the entire study; planned pregnancy, pregnancy, or lactation.

How the Study Was Run

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

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

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

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

It started in 2003-03 with completion listed for 2005-03.

Its stated primary purpose is treatment.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin Glargine in 5062 people.

With 5062 participants it is a large trial for this field.

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

More context: the Insulin Glargine compound page, all human trials.