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An Open Label, Multi-Center, Randomized, Parallel Group Study Comparing the Efficacy and Safety of Insulin VIAject™ and Regular Human Insulin in Patients With Type 2 Diabetes Mellitus
Plain-language guide to NCT00542633: phase 3 randomized trial of Insulin (regular human), 472 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT00542633
- Phase
- phase 3
- Status
- completed
- Start
- 2006-12
- Completion (planned or actual)
- 2008-08
- Participants
- 472 (actual)
- Design
- randomized, open label (everyone knows who gets what), treatment
- Conditions studied
- Type 2 Diabetes Mellitus
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
This registered phase 3 trial tested Insulin (regular human).
It had two arms (groups): A (experimental) and B (active comparator).
VIAject™.
Regular Human Insulin.
The registry classes the interventions as drug.
Who Took Part
The registry lists 472 actual participants took part.
It was open to people of any sex aged from 30 years up to 70 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Established diagnosis of type 2 diabetes for more than 1 year. Three months on a stable insulin regimen that meets the current standard of care. Age: 30 to 70 years. Body Mass Index: Not more than 45 Kg/m2.
The full record lists 5 inclusion and 23 exclusion criteria; among the exclusions: type 1 diabetes mellitus as determined by the investigator; patients being treated with a thiazolidinedione for less than 3 months; history of frequent severe hypoglycemia within the prior six months.
How the Study Was Run
The set-up was randomized, parallel-group and open-label.
The participants were allocated by chance, so the Insulin (regular human) 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 (regular human) study: the participants and staff both knew the treatment.
It started in 2006-12 with completion listed for 2008-08.
Its stated primary purpose is treatment.
What Was Measured
The main thing measured (primary outcome): change in HbA1c (time frame: 6 months).
What This Means in Plain Language
Put simply, this is a phase 3, randomized trial of Insulin (regular human) in 472 people.
The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the Insulin (regular human) compound page, all human trials.
Our Notes on the Compound
Insulin (regular human): The 51-amino-acid pancreatic hormone that lowers blood glucose; this page covers regular (short-acting) insulin studied in human trials.
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.