Efficacy Study on the Control of Blood Glucose Concentration in Type 1 Diabetic Patients

What Was Tested

The trial (phase 3) is built around Insulin Glargine and Insulin Detemir.

·Main objective: To compare the variability of fasting capillary blood glucose concentration, observed with insulin glargine combined with insulin glulisine and with insulin detemir combined with insulin glulisine, in type 1 diabetics.

Tolerance: * To record undesirable events * To evaluate the safety in use from the record of episodes of hypoglycaemia (symptomatic, diurnal, nocturnal, severe).

It had two arms (groups): I (experimental) and II (active comparator).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 88 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: Belonging to a social security scheme or covered by such a scheme. Able to continue their usual daily activities during the study. Fundal examination result less than a year old available.

The full record lists 10 inclusion and 23 exclusion criteria; among the exclusions: recent history of severe hypoglycaemia (at least 2 events in the 6 months prior to inclusion); an episode of acidocetosis in the 3 months prior to inclusion; altered hepatic function (ast or alt \>= 2.5 x normal, in the initial measurements).

How the Study Was Run

The set-up was randomized, crossover 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.

Each person switched between Insulin Glargine and the comparison at some point, usually with a gap in between.

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

It started in 2005-10 with completion listed for 2008-09.

It ran at 1 site in France.

Its stated primary purpose is treatment.

What Was Measured

It also tracked 1 secondary outcome, for example Tolerance data : undesirable events including episodes of hypoglycaemia.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin Glargine and Insulin Detemir in 88 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 and the Insulin Detemir compound page, all human trials.