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A Trial Investigating the Pharmacodynamic Properties of NN5401 in Subjects With Type 1 Diabetes
Plain-language guide to NCT01590836: phase 1 non-randomized trial of Insulin Aspart, 22 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT01590836
- Phase
- phase 1
- Status
- completed
- Start
- 2012-04
- Completion (planned or actual)
- 2012-06
- 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
This registered phase 1 trial tested Insulin Aspart.
This trial is conducted in Europe.
It had 1 arm (groups): IDeg-->IDegAsp (experimental).
The registry classes the interventions as drug.
Who Took Part
22 actual participants took part.
It was open to people of any sex aged from 18 years up to 65 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Type 1 diabetes mellitus (as diagnosed clinically) for at least 12 months. Treated with multiple daily insulin injections or continuous subcutaneous insulin infusion (CSII) for at least 12 months. Body mass index (BMI) 18.0-28.0 kg/m\^2 (both inclusive).
The full record lists 5 inclusion and 4 exclusion criteria; among the exclusions: smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent per day); not able or willing to refrain from smoking, use of nicotine gum or transdermal nicotine patches during the inpatient period.
How the Study Was Run
The set-up was non-randomized, single-group and open-label.
Everyone knew when Insulin Aspart was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.
Everyone received the same intervention, so there was no separate comparison group inside the trial.
It started in 2012-04 with completion listed for 2012-06.
It ran at 1 site in Germany.
Its stated primary purpose is treatment.
What Was Measured
It also tracked 5 secondary outcomes, for example Maximum glucose infusion rate (GIRmax), Maximum observed serum insulin degludec concentration, Area under the serum insulin aspart concentration-time curve and Maximum observed serum insulin aspart concentration.
What This Means in Plain Language
Put simply, this is a phase 1, 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.