← Human Trials & Peer-Reviewed Studies
Investigation of the Pharmacokinetic Properties of Biphasic Insulin Aspart 50 in Healthy Chinese Subjects
Plain-language guide to NCT01242826: phase 1 non-randomized trial of Insulin Aspart, 24 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT01242826
- Phase
- phase 1
- Status
- completed
- Start
- 2011-02
- Completion (planned or actual)
- 2011-03
- Participants
- 24 (actual)
- Design
- non-randomized, open label (everyone knows who gets what), treatment
- Conditions studied
- Diabetes; 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.
In addition, the safety and tolerability of BIAsp 50 will be observed.
It had 1 arm (groups): A (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 were not accepted; participants needed the condition being studied.
Examples of who could join: Considered generally healthy upon completion of medical history, physical examination, vital signs and electrocardiogram (ECG), as judged by the Investigator (the Physician). Body Mass Index (BMI): 19.0-24.0 kg/m2 (both inclusive).
The full record lists 2 inclusion and 4 exclusion criteria; among the exclusions: not able or willing to refrain from smoking during the inpatient period.
How the Study Was Run
The set-up was 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 2011-02 with completion listed for 2011-03.
It ran at 1 site in China.
Its stated primary purpose is treatment.
What Was Measured
The main thing measured (primary outcome): Area under the serum insulin aspart concentration-time curve from 0 to 24hours.
It also tracked 4 secondary outcomes, for example Area under the serum insulin aspart concentration-time curve between different time intervals, Maximum observed serum insulin aspart concentration, Number of adverse events and Number of hypoglycaemic events.
What This Means in Plain Language
Put simply, this is a phase 1, non-randomized 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.