Extension to Study HMR1964A/3011 in Belgium

What Was Tested

This registered phase 4 trial tested Insulin Glargine.

The purpose of this trial is to allow patients to continue on HOE 901 until launch and to gather additional long-term safety data.

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

The registry classes the interventions as drug.

Who Took Part

32 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 treated with HOE 901 in a previous clinical study with HOE 901 for whom a change of basal insulin would destabilise glucose metabolism. Subjects who are likely to comply with the investigator's instructions.

The full record lists 3 inclusion and 5 exclusion criteria; among the exclusions: evidence of an uncooperative attitude; subject not on adequate contraception, or who is pregnant, or breast feeding; subject unable to understand informed consent.

How the Study Was Run

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

Because people in this Insulin Glargine study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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 2002-11 with completion listed for 2004-04.

It ran at 1 site in Belgium.

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 32 people.

Its size is small, so on its own it can only give an early look.

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.