A Trial Investigating the Efficacy and Safety of Insulin Degludec in Children and Adolescents With Type 1 Diabetes Mellitus

What Was Tested

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

This trial is conducted in Africa, Asia, Europe and the United States of America (USA).

It had two arms (groups): Insulin Degludec + Insulin Aspart (experimental) and Insulin Detemir +Insulin Aspart (experimental).

The registry classes the interventions as drug.

Who Took Part

350 actual participants took part.

It was open to people of any sex aged from 1 Year up to 17 years.

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

Examples of who could join: Male or female diagnosed with type 1 diabetes mellitus (T1DM) (based on clinical judgement and supported by laboratory analysis as per local guidelines). Ongoing daily treatment with insulin (any regimen) for at least 3 months prior to Visit 1 (screening). No OADs (oral anti-diabetic drugs) are allowed.

The full record lists 4 inclusion and 8 exclusion criteria; among the exclusions: known or suspected hypersensitivity to trial product(s) or related products; previous participation in this trial. participation is defined as randomisation; girls who are pregnant, breastfeeding or intend to become pregnant.

How the Study Was Run

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

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

Groups ran in parallel: each of the participants stayed in one arm throughout.

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

It started in 2012-01-16 with completion listed for 2013-07-30.

It ran at 81 sites in United States (28), Japan (15), Russia (7), Finland (5), Netherlands (5) and United Kingdom (5).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change From Baseline in HbA1c (Glycosylated Haemoglobin) (%) at 26 Weeks (Analysed by Central Laboratory) (time frame: Week 0, week 26).

It also tracked 9 secondary outcomes, for example Change From Baseline in HbA1c (%) at 52 Weeks (Analysed by Central Laboratory), Change From Baseline in Fasting Blood Glucose (FPG) at 26 Weeks (Analysed by Central Laboratory), Change From Baseline in Fasting Blood Glucose (FPG) at 52 Weeks (Analysed by Central Laboratory), Number of Treatment Emergent Adverse Events (TEAEs) and Number of Hypoglycaemic Episodes.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin Aspart and Insulin Detemir in 350 people.

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.