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Long Term Safety of Biphasic Insulin Aspart 30 in Juveniles With Type 1 Diabetes
Plain-language guide to NCT01486381: phase 3 non-randomized trial of Insulin Aspart, 22 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT01486381
- Phase
- phase 3
- Status
- completed
- Start
- 2002-03-20
- Completion (planned or actual)
- 2003-05-30
- Participants
- 22 (actual)
- Design
- non-randomized, open label (everyone knows who gets what), treatment
- Conditions studied
- Diabetes; Diabetes Mellitus, Type 1
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
In this phase 3 trial, researchers set out to test Insulin Aspart.
This trial is conducted in South Africa.
The aim of this trial is to investigate Long term safety of biphasic insulin aspart 30 in juveniles with type 1 diabetes previously treated in trial BIAsp-1240.
It had 1 arm (groups): BIAsp 30 (experimental).
The registry classes the interventions as drug.
Who Took Part
Enrollment: 22 actual participants took part.
It was open to people of any sex aged from 10 years up to 17 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Signed informed consent obtained before any trial-related activities according to local requirements. (Trial-related activities are any procedure that would not have been performed during normal management of the subject). The subject must have completed the trial BIAsp-1240.
The full record lists 2 inclusion and 0 exclusion criteria.
How the Study Was Run
Design: non-randomized, single-group and open-label.
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 2002-03-20 with completion listed for 2003-05-30.
It ran at 2 sites in South Africa (2).
Its stated primary purpose is treatment.
What Was Measured
Researchers chose this as the main measure: Number of hypoglycaemic episodes. Standard safety parameters: Haematology, biochemistry and vital signs.
It also tracked 3 secondary outcomes, for example HbA1c (glycosylated haemoglobin), Blood glucose level at each time-point in the 8-point glucose profile and BMI (Body Mass Index).
What This Means in Plain Language
Put simply, this is a phase 3, non-randomized trial of Insulin Aspart in 22 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 Aspart compound page, all human trials.
Our Notes on the Compound
Insulin Aspart: A rapid-acting mealtime insulin analog; brands include NovoLog, NovoRapid and Fiasp.
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.