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Efficacy and Safety of a Fixed or a Flexible Supplementary Insulin Therapy in Type 2 Diabetes
Plain-language guide to NCT00274274: phase 4 randomized trial of Insulin Aspart and Insulin Detemir, 373 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT00274274
- Phase
- phase 4
- Status
- completed
- Start
- 2005-09
- Completion (planned or actual)
- 2006-11
- Participants
- 373 (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
This registered phase 4 trial tested Insulin Aspart and Insulin Detemir.
This trial is conducted in Europe.
The registry classes the interventions as drug.
Who Took Part
373 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 more than 6 months. Treatment with 1 or more oral anti-diabetic drugs or insulin, or a combination of these for more than 3 months. Body Mass Index (BMI) less than or equal to 40 kg/m2.
The full record lists 4 inclusion and 3 exclusion criteria; among the exclusions: treatment with short acting insulin(s) for longer than 10 days; current treatment with tzds. a tzd medication must be stopped at least 14 days before the randomization; proliferative retinopathy or maculopathy requiring acute or laser treatment within the last 6 months.
How the Study Was Run
It was run as a randomized, parallel-group and open-label study.
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.
Being open-label, the Insulin Aspart study did not mask who received what.
It started in 2005-09 with completion listed for 2006-11.
It ran at 1 site in Germany.
Its stated primary purpose is treatment.
What Was Measured
Researchers chose this as the main measure: HbA1c (time frame: after 52 weeks).
It also tracked 6 secondary outcomes, for example Blood glucose profiles, Quality of Life, Frequency of BG measurements, Safety parameters and Duration of education.
What This Means in Plain Language
Put simply, this is a phase 4, randomized trial of Insulin Aspart and Insulin Detemir in 373 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 and the Insulin Detemir compound page, all human trials.
Our Notes on the Compounds
Insulin Aspart: A rapid-acting mealtime insulin analog; brands include NovoLog, NovoRapid and Fiasp.
Insulin Detemir: A long-acting basal insulin analog sold as Levemir.
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.