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Comparison of NN5401 With Biphasic Insulin Aspart 30 in Type 2 Diabetes
Plain-language guide to NCT01009580: phase 3 randomized trial of Insulin Aspart, 447 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT01009580
- Phase
- phase 3
- Status
- completed
- Start
- 2009-11-05
- Completion (planned or actual)
- 2010-08-23
- Participants
- 447 (actual)
- Design
- randomized, open label (everyone knows who gets what), treatment
- Conditions studied
- Diabetes; Diabetes Mellitus, Type 2
- Results posted
- yes
What This Study Did, in Plain Language
What Was Tested
In this phase 3 trial, researchers set out to test Insulin Aspart.
This trial is conducted in Asia, Europe and Oceania.
The aim of this clinical trial is to compare NN5401 (insulin degludec/insulin aspart) with biphasic insulin aspart 30 in subjects with type 2 diabetes.
It had two arms (groups): IDegAsp BID (experimental) and BIAsp 30 BID (experimental).
The registry classes the interventions as drug.
Who Took Part
447 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 mellitus (diagnosed clinically) for at least 6 months. Body Mass Index (BMI) below or equal to 40.0 kg/m\^2.
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.
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 2009-11-05 with completion listed for 2010-08-23.
It ran at 53 sites in India (9), Denmark (7), Poland (6), Sweden (6), Australia (5) and Finland (5).
Its stated primary purpose is treatment.
What Was Measured
The main thing measured (primary outcome): Change in Glycosylated Haemoglobin (HbA1c) (time frame: Week 0, Week 26).
It also tracked 3 secondary outcomes, for example Mean of 9-point Self Measured Plasma Glucose Profile (SMPG), Rate of Confirmed Hypoglycaemic Episodes and Rate of Nocturnal Confirmed Hypoglycaemic Episodes.
What This Means in Plain Language
Put simply, this is a phase 3, randomized trial of Insulin Aspart in 447 people.
The trial is marked completed; results are posted on the registry, and this page does not restate them.
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.