Within-subject Variability of Insulin Detemir in Children and Adolescents With Type 1 Diabetes

What Was Tested

In this phase 1 trial, researchers set out to test Insulin Glargine and Insulin Detemir.

This trial is conducted in Europe.

It had two arms (groups): Insulin detemir (experimental) and Insulin glargine (active comparator).

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 6 years up to 17 years.

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

Examples of who could join: Type 1 diabetes for at least 12 months. Body mass index (BMI) for children (6 to 12 years): 15-20 kg/m\^2 (both inclusive). Body mass index (BMI) for adolescents (13 to 17 years): 18-25 kg/m\^2 (both inclusive). Current treatment with insulin at least twice daily.

The full record lists 5 inclusion and 3 exclusion criteria; among the exclusions: receipt of any investigational product within the last four weeks; known or suspected allergy to trial products or related products.

How the Study Was Run

The set-up was randomized, crossover and double-blind.

Random assignment meant chance, not the researchers, decided who got Insulin Glargine and who got the comparison, which limits bias.

In the crossover set-up each of the participants took both Insulin Glargine and the comparison in turn, acting as their own control.

As a double-blind Insulin Glargine study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant and investigator.

It started in 2005-05 with completion listed for 2005-10.

It ran at 1 site in Germany.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Area under the insulin concentration curve (AUC).

It also tracked 3 secondary outcomes, for example Maximum insulin concentration (Cmax), Time to maximum insulin concentration (tmax) and Adverse events.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Insulin Glargine and Insulin Detemir 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 and the Insulin Detemir compound page, all human trials.