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 1 Diabetes Mellitus

What Was Tested

The trial (phase 3) is built around 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

Enrollment: 462 actual participants took part.

It was open to people of any sex aged from 18 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 1 diabetes for more than 1 year. Three months on a stable insulin regimen that meets the current standard of care and that includes at least two daily insulin injections. Age: 18 to 70 years. Body Mass Index: 18 - 38 Kg/m2.

The full record lists 5 inclusion and 23 exclusion criteria; among the exclusions: type 2 diabetes mellitus as determined by the investigator; history of frequent severe hypoglycemia within the prior six months; C-peptide \> 1.0 ng/ml unless there is a documented history of ketoacidosis or a documented history of a positive anti GAD test.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

Because people in this Insulin (regular human) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The Insulin (regular human) group and the comparison group ran side by side rather than switching.

Being open-label, the Insulin (regular human) study did not mask who received what.

It started in 2006-09 with completion listed for 2008-07.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: 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 462 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.