Effect of Tight Control of Blood Glucose During Hyper-CVAD Chemotherapy For Acute Lymphocytic Leukemia (ALL)

What Was Tested

This registered phase 3 trial tested Insulin Glargine and Insulin Aspart.

It had two arms (groups): Conventional Care (no intervention) and Intensive Insulin (other).

Control Group: Conventional care using blood sugar management with regular human insulin.

Intervention Group: Intense blood sugar management with Insulin Aspart + Insulin Glargine.

The registry classes the interventions as drug.

More on the Plan

You will be randomly assigned (as in the toss of a coin) to one of two treatment groups.

Participants in one group will receive blood sugar management with regular human insulin.

You will receive additional blood tests (about 1 tablespoon each) at the time of entry on the study and after about every 2 to 4 courses of chemotherapy while on the study.

These blood tests help better define the severity of your high blood sugar and your body's ability to metabolize sugar.

Who Took Part

Enrollment: 52 actual participants took part.

It was open to people of any sex aged from 15 years with no upper age limit.

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

Examples of who could join: Age \>/= 15 years. Previously untreated ALL, Burkitt's lymphoma, or lymphoblastic leukemia receiving induction chemotherapy with hyper-CVAD or variants of the hyper-CVAD regimen.

The full record lists 3 inclusion and 4 exclusion criteria; among the exclusions: history of type i diabetes mellitus; pregnancy or breast feeding; allergy to insulin or insulin products.

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 Glargine and who got the comparison, which limits bias.

The Insulin Glargine group and the comparison group ran side by side rather than switching.

Everyone knew when Insulin Glargine was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2004-04 with completion listed for 2012-04.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: 1-Year Overall Survival Rate (time frame: 1 year). Overall Survival. Progression Free Survival (PFS) (time frame: Date of complete remission to disease progression, assessed for approximately 6 years).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin Glargine and Insulin Aspart in 52 people.

It ended early (terminated); results are posted on the registry, and this page does not restate them.

More context: the Insulin Glargine compound page and the Insulin Aspart compound page, all human trials.