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Effect of Biphasic Insulin Aspart 30 Combined With Metformin on Blood Glucose Control in Subjects With Type 2 Diabetes Inadequately Controlled With Basal Insulin
Plain-language guide to NCT00669864: phase 4 non-randomized trial of Insulin Aspart, 293 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT00669864
- Phase
- phase 4
- Status
- completed
- Start
- 2007-11
- Completion (planned or actual)
- 2009-04
- Participants
- 293 (actual)
- Design
- non-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 4 trial, researchers set out to test Insulin Aspart.
This trial is conducted in Asia.
This single arm trial aims to evaluate the blood glucose control with twice daily biphasic insulin aspart 30 in combination with metformin in Chinese subjects with type 2 diabetes inadequately controlled with once or twice daily basal insulin.
It had 1 arm (groups): BIAsp 30-30 (experimental).
The registry classes the interventions as drug.
Who Took Part
Enrollment: 293 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. Currently treated with basal insulin once or twice daily with or without oral anti-diabetic drugs (OADs) for at least 3 months. BMI (Body Mass Index) maximum 40 kg/m2.
The full record lists 4 inclusion and 2 exclusion criteria; among the exclusions: metformin contraindications according to local practice; systemically treated with tzds (thiazolidinediones) for more than one month within 6 months prior to this trial.
How the Study Was Run
Design: non-randomized, single-group and open-label.
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.
Everyone received the same intervention, so there was no separate comparison group inside the trial.
It started in 2007-11 with completion listed for 2009-04.
It ran at 1 site in China.
Its stated primary purpose is treatment.
What Was Measured
Primary outcome: Change in HbA1c (Glycosylated Haemoglobin A1c) (time frame: week 0, week 16).
It also tracked 5 secondary outcomes, for example Change in 8-point Plasma Glucose Profile, Hypoglycaemic Episodes and Hypoglycaemic Episodes, Diurnal/Nocturnal.
What This Means in Plain Language
Put simply, this is a phase 4, non-randomized trial of Insulin Aspart in 293 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.