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A Trial Investigating the Pharmacokinetic Properties of Insulin Degludec/Insulin Aspart in Healthy Chinese Subjects
Plain-language guide to NCT02844790: phase 1 interventional trial of Insulin Aspart, 24 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT02844790
- Phase
- phase 1
- Status
- completed
- Start
- 2016-07-26
- Completion (planned or actual)
- 2016-09-26
- Participants
- 24 (actual)
- Design
- na, open label (everyone knows who gets what), treatment
- Conditions studied
- Healthy
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
The trial (phase 1) is built around Insulin Aspart.
This trial is conducted in Asia.
It had 1 arm (groups): IDegAsp (experimental).
The registry classes the interventions as drug.
Who Took Part
Enrollment: 24 actual participants took part.
It was open to people of any sex aged from 18 years up to 45 years.
Healthy volunteers could join, not only people with the condition.
Examples of who could join: Male or female Chinese subject aged 18-45 years (both inclusive). Considered generally healthy upon completion of medical history, physical examination, vital signs and electrocardiogram (ECG), as judged by the investigator. Body mass index 19.0-24.0 kg/m\^2 (both inclusive).
The full record lists 3 inclusion and 3 exclusion criteria; among the exclusions: smoking more than 5 cigarettes (including nicotine substitute products), or the equivalent, per.
How the Study Was Run
Design: 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 2016-07-26 with completion listed for 2016-09-26.
It ran at 1 site in China.
Its stated primary purpose is treatment.
What Was Measured
Researchers chose this as the main measure: Area under the serum insulin degludec concentration-time curve. Area under the serum insulin aspart concentration-time curve.
It also tracked 4 secondary outcomes, for example Maximum observed serum insulin degludec concentration, Maximum observed serum insulin aspart concentration, Time to maximum observed serum insulin degludec concentration and Time to maximum observed serum insulin aspart concentration.
What This Means in Plain Language
Put simply, this is a phase 1 trial of Insulin Aspart in 24 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.