← Human Trials & Peer-Reviewed Studies
Efficacy and Safety of Biphasic Insulin Aspart 30 FlexPen™ in Subjects With Type 2 Diabetes
Plain-language guide to NCT01704378: phase 4 non-randomized trial of Insulin Aspart, 89 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT01704378
- Phase
- phase 4
- Status
- completed
- Start
- 2001-04-18
- Completion (planned or actual)
- 2003-03-14
- Participants
- 89 (actual)
- Design
- non-randomized, open label (everyone knows who gets what), treatment
- Conditions studied
- Diabetes; Diabetes Mellitus, Type 2
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
The trial (phase 4) is built around Insulin Aspart.
This trial is conducted in Europe.
The aim of this trial investigate the the long-term safety of biphasic insulin aspart 30 in subjects with type 2 diabetes.
It had 1 arm (groups): BIAsp (experimental).
The registry classes the interventions as drug.
Who Took Part
The registry lists 89 actual participants took part.
It was open to people of any sex aged from 18 years with no upper age limit.
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. Completed the trial BIAsp-1236.
The full record lists 2 inclusion and 4 exclusion criteria; among the exclusions: planned changes in use of any prescription medication that may interfere with glucose regulation; known or suspected allergy to trial products or related products; women who are having the intention of becoming pregnant, or are judged not to be using adequate contraceptive measures.
How the Study Was Run
It was run as a non-randomized, single-group and open-label study.
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 2001-04-18 with completion listed for 2003-03-14.
It ran at 17 sites in United Kingdom (6), Norway (5), Finland (3) and Sweden (3).
Its stated primary purpose is treatment.
What Was Measured
Researchers chose this as the main measure: Number of Hypoglycaemic episodes. Occurrence of adverse events.
It also tracked 3 secondary outcomes, for example HbA1c (glycosylated haemoglobin), Prandial increment in blood glucose and 7-point blood glucose profile.
What This Means in Plain Language
Put simply, this is a phase 4, non-randomized trial of Insulin Aspart in 89 people.
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.