← Human Trials & Peer-Reviewed Studies
Efficacy and Safety of NovoMix® 30 in Subjects With Type 2 Diabetes
Plain-language guide to NCT01467401: phase 4 randomized trial of Insulin Aspart, 292 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT01467401
- Phase
- phase 4
- Status
- completed
- Start
- 2002-08-19
- Completion (planned or actual)
- 2003-05-15
- Participants
- 292 (actual)
- Design
- 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.
It had two arms (groups): A (experimental) and B (active comparator).
The registry classes the interventions as drug.
Who Took Part
The registry lists 292 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: Type 2 diabetes for at least 24 months. Insulin treatment for the pase 3 months. BMI (Body Mass Index) below 40 kg/m\^2. Ability and willingness to perform self-blood glucose monitoring.
The full record lists 5 inclusion and 3 exclusion criteria; among the exclusions: receipt of any investigational drug within 4 weeks prior to this trial; treatment of ohas (oral hypoglycaemic agents) within 4 weeks prior to this trial.
How the Study Was Run
Design: randomized, parallel-group and open-label.
Random assignment meant chance, not the researchers, decided who got Insulin Aspart and who got the comparison, which limits bias.
Groups ran in parallel: each of the participants stayed in one arm throughout.
Nothing was hidden in this open-label Insulin Aspart study: the participants and staff both knew the treatment.
It started in 2002-08-19 with completion listed for 2003-05-15.
It ran at 57 sites in Sweden (39), Denmark (9) and Norway (9).
Its stated primary purpose is treatment.
What Was Measured
Researchers chose this as the main measure: HbA1c (glycolated haemoglobin).
It also tracked 5 secondary outcomes, for example Prandial increment in blood glucose, 7-point blood glucose profile, Number and severity of adverse events, Number and severity of local tolerability issues at the injection site and Number and severity of hypoglycaemic episodes.
What This Means in Plain Language
Put simply, this is a phase 4, randomized trial of Insulin Aspart in 292 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.