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Effect of Biphasic Insulin Aspart 30 on Blood Glucose Control in Subjects With Type 2 Diabetes
Plain-language guide to NCT00280046: phase 3 randomized trial of Insulin Aspart, 307 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT00280046
- Phase
- phase 3
- Status
- completed
- Start
- 2003-11
- Completion (planned or actual)
- 2004-07
- Participants
- 307 (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
The trial (phase 3) is built around Insulin Aspart.
This trial was conducted in Russian Federation.
This trial aimed for a comparison of the effect on glycemic control in subjects with type 2 diabetes of three different treatment regimens: biphasic insulin aspart 30 thrice daily, biphasic insulin aspart 30 twice daily in combination with metformin and treatment with oral anti-diabetic drugs.
The registry classes the interventions as drug.
Who Took Part
The registry lists 307 actual participants took part.
It was open to people of any sex aged from 40 years up to 70 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Type 2 diabetes, currently treated with one or more oral hypoglycemic agent.
The full record lists 2 inclusion and 1 exclusion criteria; among the exclusions: impaired hepatic, renal or cardiac function.
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.
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 2003-11 with completion listed for 2004-07.
It ran at 11 sites in Russia (11).
Its stated primary purpose is treatment.
What Was Measured
Primary outcome: HbA1c (time frame: after 16 weeks of treatment).
It also tracked 4 secondary outcomes, for example Self-measured 7-point capillary plasma glucose profile, Change in body weight, Incidence of hypoglycaemic episodes and adverse events and Quality of Life.
What This Means in Plain Language
Put simply, this is a phase 3, randomized trial of Insulin Aspart in 307 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.