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Comparison of Insulin Aspart Produced by the NN2000 Process to the Current Process in Type 1 Diabetes
Plain-language guide to NCT00604656: phase 3 randomized trial of Insulin Aspart, 241 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT00604656
- Phase
- phase 3
- Status
- completed
- Start
- 2003-05-05
- Completion (planned or actual)
- 2004-01-29
- Participants
- 241 (actual)
- Design
- randomized, open label (everyone knows who gets what), treatment
- Conditions studied
- Diabetes; Diabetes Mellitus, Type 1
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
The trial (phase 3) is built around Insulin Aspart.
This trial is conducted in Europe.
The registry classes the interventions as drug.
Who Took Part
Enrollment: 241 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 type 1 diabetes. Duration of diabetes for at least 12 months. Treatment with insulin aspart for at least 3 months before trial start. Body Mass Index (BMI) below 35.0 kg/m2.
The full record lists 5 inclusion and 4 exclusion criteria; among the exclusions: recurrent major hypoglycaemia that may interfere with trial participation (as judged by the investigator); known hypoglycaemia unawareness as judged by the investigator; known hypersensitivity or allergy.
How the Study Was Run
Design: randomized, parallel-group and open-label.
The participants were allocated by chance, so the Insulin Aspart group and the comparison group should start out alike.
The Insulin Aspart group and the comparison group ran side by side rather than switching.
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.
It started in 2003-05-05 with completion listed for 2004-01-29.
It ran at 34 sites in Germany (15), Italy (10), Poland (5), Czechia (2) and Hungary (2).
Its stated primary purpose is treatment.
What Was Measured
Researchers chose this as the main measure: Insulin aspart antibodies (time frame: After 6 months treatment).
It also tracked 3 secondary outcomes, for example Occurrence of adverse events, Incidence of hypoglycaemic episodes and HbA1c.
What This Means in Plain Language
Put simply, this is a phase 3, randomized trial of Insulin Aspart in 241 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.