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Efficacy and Safety of Biphasic Insulin Aspart 30 in Type 1 or Type 2 Diabetes
Plain-language guide to NCT01467323: phase 3 randomized trial of Insulin Aspart, 303 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT01467323
- Phase
- phase 3
- Status
- completed
- Start
- 1998-04
- Completion (planned or actual)
- 1998-09
- Participants
- 303 (actual)
- Design
- randomized, open label (everyone knows who gets what), treatment
- Conditions studied
- Diabetes; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
This registered phase 3 trial tested 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
303 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: Subjects with insulin requiring type 1 or type 2 diabetes for at least 24 months. Current treatment with human insulin (either premix of short and long/intermediate acting insulin) in a twice daily treatment regimen preparation and/or self-mix for at least 12 months. Body mass index (BMI) below or equal to 35.0 kg/m\^2.
The full record lists 4 inclusion and 6 exclusion criteria; among the exclusions: treatment with oral hypoglycaemic agents within the month prior to inclusion; recurrent severe hypoglycaemia (as judged by the investigator); active proliferative retinopathy.
How the Study Was Run
The set-up was 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.
The Insulin Aspart group and the comparison group ran side by side rather than switching.
Being open-label, the Insulin Aspart study did not mask who received what.
It started in 1998-04 with completion listed for 1998-09.
It ran at 37 sites in Germany (16), United Kingdom (15), Ireland (3), Austria (2) and Switzerland (1).
Its stated primary purpose is treatment.
What Was Measured
The main thing measured (primary outcome): HbA1c (glycosylated haemoglobin A1c).
It also tracked 3 secondary outcomes, for example 8-point blood glucose profiles, Incidence of hypoglycaemic episodes and Occurrence of adverse events.
What This Means in Plain Language
Put simply, this is a phase 3, randomized trial of Insulin Aspart in 303 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.