Glycemic Control and Complications in Diabetes Mellitus Type 2 (VADT)

What Was Tested

This registered phase 3 trial tested Insulin (regular human).

The study consists of a two-year accrual period and five years of follow-up (7 years total) of 1700 patients across 20 centers.

It had two arms (groups): Standard glycemic control (active comparator) and Intensive glycemic control (experimental).

The registry classes the interventions as drug.

More on the Plan

Intervention: The intervention is tight glycemic control, aiming at normalization of HbA1c.

This will be achieved through stepped care therapy, using all categories of tools available to most diabetologists.

These categories include: patient education of diabetes control (e.g. diet, exercise, etc.), oral diabetes medications, and insulin.

All drugs to be used are approved.

Who Took Part

1791 actual participants took part.

It was open to people of any sex aged from 40 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

The full record lists 1 inclusion and 20 exclusion criteria; among the exclusions: angina pectoris, canadian class i-ii,; congestive heart failure, class iii-iv,; stroke, incapacitating or in last 6 months,.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

Random assignment meant chance, not the researchers, decided who got Insulin (regular human) and who got the comparison, which limits bias.

Groups ran in parallel: each of the participants stayed in one arm throughout.

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

It started in 2000-12-01 with completion listed for 2008-05-30.

It ran at 21 sites in United States (20) and Puerto Rico (1).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Primary Major Macrovascular Events (time frame: Post baseline time to the first major macrovascular event up to 82 months).

It also tracked 1 secondary outcome, for example Secondary Endpoint.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin (regular human) in 1791 people.

With 1791 participants it is a large trial for this field.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Insulin (regular human) compound page, all human trials.