Intensive Glycemic Control on Infectious Morbidity In Patients With Acute Leukemia

What Was Tested

The trial (phase 3) is built around Insulin Glargine.

It had two arms (groups): Arm I (experimental) and Arm II (active comparator).

The registry classes the interventions as biological and drug.

More on the Plan

Beginning 24 hours after maintenance of oral or enteral feedings patients receive an intensive regimen of insulin glargine and insulin glulisine (Apidra™) subcutaneously for 4 weeks as needed.

Insulin may also be added to TPN if needed at the investigator's discretion.

After completion of study treatment, patients are followed up for 4 weeks.

Who Took Part

It was open to people of any sex aged from 18 years with no upper age limit.

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

Examples of who could join: Histologically confirmed acute myeloid leukemia or acute lymphoid leukemia. Newly diagnosed or relapsed disease. Undergoing induction or salvage chemotherapy treatment. ECOG performance status 0-3. Not pregnant or nursing.

The full record lists 12 inclusion and 0 exclusion criteria.

How the Study Was Run

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

Random assignment meant chance, not the researchers, decided who got Insulin Glargine 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 Glargine study did not mask who received what.

It started in 2009-05 with completion listed for 2010-03.

It ran at 1 site in United States.

Its stated primary purpose is supportive care.

What Was Measured

Researchers chose this as the main measure: Incidence of new infections (time frame: 4 years).

It also tracked 13 secondary outcomes, for example Number of episodes of infection, Duration of neutropenia, Number of days of bacteremia/fungemia, Number of days of fever, Duration of nutrition and Duration of mucositis.

What This Means in Plain Language

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

It was withdrawn before enrolling anyone; no results are posted to the registry yet, so nothing here describes outcomes.

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