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Safety and Effect of Biphasic Insulin Aspart 50 in Patients With Type 2 Diabetes Mellitus.
Plain-language guide to NCT00476437: phase 3 randomized trial of Insulin Aspart, 81 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT00476437
- Phase
- phase 3
- Status
- completed
- Start
- 2007-04
- Completion (planned or actual)
- 2007-11
- Participants
- 81 (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
In this phase 3 trial, researchers set out to test Insulin Aspart.
This trial is conducted in Japan.
The purpose of this trial is to investigate the safety and the effect of biphasic insulin aspart 50 compared to biphasic human insulin 50 in patients with type 2 diabetes mellitus.
The registry classes the interventions as drug.
Who Took Part
Enrollment: 81 actual participants took part.
It was open to people of any sex aged from 20 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. Current treatment with pre-mixed human insulin preparation or biphasic/pre-mixed insulin analogue in twice daily treatment for at least 8 weeks. BMI: less than 30.0 kg/m2.
The full record lists 4 inclusion and 4 exclusion criteria; among the exclusions: treatment with oral hypoglycaemic agents within the last 4 weeks; treatment with insulin sensitizer within the last 12 weeks; A lifestyle that is considered unsuitable for this trial (frequent or routine night shift workers etc.).
How the Study Was Run
Design: randomized, parallel-group and open-label.
Because people in this Insulin Aspart study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.
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 2007-04 with completion listed for 2007-11.
It ran at 1 site in Japan.
Its stated primary purpose is treatment.
What Was Measured
The main thing measured (primary outcome): Incidence of hypoglycaemic episodes (time frame: During 16 weeks of treatment).
What This Means in Plain Language
Put simply, this is a phase 3, randomized trial of Insulin Aspart in 81 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.