Phenotype Evaluation in Insulin Naive Patients Using Lantus (Insulin Glargine)

What Was Tested

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

Secondary objectives: * Determination of the predictive criterion of HbA1c final, * Determination of the predictive criterion of weight variation, * Description of the glycemic and therapeutic criteria in the both groups of responders (positive and negative responders), * Assessment of the lipidic parameters according to the HbA1c and weight changes during the study (final value - basal value).

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

The registry classes the interventions as drug.

Who Took Part

The registry lists 280 actual participants took part.

It was open to people of any sex aged from 30 years up to 69 years.

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

Examples of who could join: Known type 2 diabetes for at least 2 years. No history of Ketoacidosis. BMI\> 25 \& \<35 kg/m2. Type 2 diabetes treated with oral bi or tritherapy for at least 6 months. With insulin release stimulator: sulfonamide or glinide at maximal posology (as defined in the SmPC),.

The full record lists 7 inclusion and 11 exclusion criteria; among the exclusions: type 1 diabetes; glucophage intolerability; breast feeding.

How the Study Was Run

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

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

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

It started in 2003-04 with completion listed for 2004-09.

It ran at 1 site in France.

Its stated primary purpose is treatment.

What Was Measured

It also tracked 4 secondary outcomes, for example Determination of the predictive criterion of HbA1c final, Determination of the predictive criterion of weight variation, HbA1c and weight variations (final value - basal value) and AE/SAE evaluation.

What This Means in Plain Language

Put simply, this is a phase 4, non-randomized trial of Insulin Glargine in 280 people.

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.