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Safety Follow-up on Children and Adolescents With Type 1 Diabetes Treated With Insulin Detemir. An Extension to Trial NN304-1689
Plain-language guide to NCT00623194: phase 3 non-randomized trial of Insulin Aspart and Insulin Detemir, 146 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT00623194
- Phase
- phase 3
- Status
- completed
- Start
- 2008-02
- Completion (planned or actual)
- 2009-09
- Participants
- 146 (actual)
- Design
- non-randomized, open label (everyone knows who gets what), treatment
- Conditions studied
- Diabetes; Diabetes Mellitus, Type 1
- Results posted
- yes
What This Study Did, in Plain Language
What Was Tested
This registered phase 3 trial tested Insulin Aspart and Insulin Detemir.
This trial is conducted in Europe.
The aim of this research is to assess the safety of continuous treatment with insulin detemir following participation in trial NN304-1689 (NCT00435019) on antibody development.
It had 1 arm (groups): insulin detemir (experimental).
The registry classes the interventions as drug.
Who Took Part
146 actual participants took part.
It was open to people of any sex aged from 3 years up to 17 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Finalised 52 weeks of treatment with insulin detemir in trial NN304-1689.
The full record lists 3 inclusion and 3 exclusion criteria; among the exclusions: pregnant or the intention of becoming pregnant; previous participation in this trial (defined as enrolment).
How the Study Was Run
It was run as a non-randomized, single-group and open-label study.
Nothing was hidden in this open-label Insulin Aspart study: the participants and staff both knew the treatment.
Everyone received the same intervention, so there was no separate comparison group inside the trial.
It started in 2008-02 with completion listed for 2009-09.
It ran at 32 sites in Finland (4), Russia (4), Turkey (Türkiye) (4), Bulgaria (3), Czechia (3) and Denmark (3).
Its stated primary purpose is treatment.
What Was Measured
The main thing measured (primary outcome): Insulin Detemir-insulin Aspart Cross-reacting Antibodies (time frame: week 0, 52 and 104).
It also tracked 16 secondary outcomes, for example Development of Insulin Detemir Specific Antibodies and Insulin Aspart Specific Antibodies, Glycosylated Haemoglobin A1c (HbA1c), Fasting Plasma Glucose Values, Hypoglycaemic Episodes, BMI (Body Mass Index) and SD-score (Z-score) for Body Weight.
What This Means in Plain Language
Put simply, this is a phase 3, non-randomized trial of Insulin Aspart and Insulin Detemir in 146 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.
Our Notes on the Compounds
Insulin Aspart: A rapid-acting mealtime insulin analog; brands include NovoLog, NovoRapid and Fiasp.
Insulin Detemir: A long-acting basal insulin analog sold as Levemir.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.