Comparison of Insulin Detemir and Insulin Aspart in 2 Separate Injections Twice Daily to Extemporaneous Mixing Injection Regimen Twice Daily - The Paediatric Mixing Trial

What Was Tested

In this phase 4 trial, researchers set out to test Insulin Aspart and Insulin Detemir.

This trial is conducted in Europe.

It had two arms (groups): Mixed injection (experimental) and Separate injection (active comparator).

The registry classes the interventions as drug.

Who Took Part

25 actual participants took part.

It was open to people of any sex aged from 6 years up to 18 years.

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

Examples of who could join: Parents' Informed Consent (IC) obtained before any trial-related activities. Obtained child's assent (when possible). Type 1 diabetes. Treatment with insulin detemir and insulin aspart either in extemporaneous mixed or separate injections.

The full record lists 5 inclusion and 4 exclusion criteria; among the exclusions: mental incapacity, unwillingness or language barrier precluding adequate understanding or co-operation; any other condition that the investigator (trial physician) feels would interfere with trial participation or evaluation of results.

How the Study Was Run

Design: randomized, parallel-group and open-label.

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

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

Nothing was hidden in this open-label Insulin Aspart study: the participants and staff both knew the treatment.

It started in 2007-09 with completion listed for 2009-03.

It ran at 1 site in France.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Glycosylated Haemoglobin A1c (HbA1c) (time frame: Week 0 and Week 8). Glycosylated Haemoglobin A1c (HbA1c) (time frame: Week 0 and Week 8).

It also tracked 28 secondary outcomes, for example Fructosamine, Self-measured Plasma Glucose Profile (Before Breakfast), Self-measured Plasma Glucose Profile (After Breakfast), Self-measured Plasma Glucose Profile (Before Dinner), Self-measured Plasma Glucose Profile (After Dinner) and Weight Z Score.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin Aspart and Insulin Detemir in 25 people.

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

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Insulin Aspart compound page and the Insulin Detemir compound page, all human trials.