Lantus in the Treatment of Type 1 Diabetes Children

What Was Tested

In this phase 4 trial, researchers set out to test Insulin Glargine.

In this study, the researchers plan to examine the difference in effect on blood glucose control in patients who will be on either conventional insulin therapy (i.e. using NPH and Humalog twice daily, injected separately) or on intensive insulin management (IIM-several shots of short acting and Glargine insulin).

Those on IIM will be mixing the insulin Glargine with the short-acting insulin analog prior to injecting.

The Hemoglobin A1c (HbA1c) results will be used to monitor blood glucose control over a 6 month period.

The registry classes the interventions as drug.

More on the Plan

To achieve the goals of the DCCT, a number of new insulin analogs( man-made insulins ) are now being incorporated into the management of patients with T1DM.

These insulin analogs are gaining importance with their ability to overcome the major obstacle to intensive insulin therapy, namely low blood glucose.

In particular, insulin Glargine, considered a basal insulin, is being extensively used for management as an alternative to continuous insulin therapy injected into the tissue just below the skin.

The major drawback to using insulin Glargine is that it has to be given as a separate injection and cannot be mixed with other insulins.

Who Took Part

Enrollment: 60 planned participants were the target.

It was open to people of any sex aged from 6 years up to 25 years.

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

Examples of who could join: Age greater than 6 years of age but less than 25 years of age (Insulin glargine has been approved for use in children 6 years and older). Patients newly diagnosed with T1DM within the past 3 months. Have a BMI of less than the 90th percentile for age. Randomization of subjects willing to participate in the study.

The full record lists 5 inclusion and 7 exclusion criteria; among the exclusions: lack of supportive family; evidence or history of chemical abuse; age less than 6 years or greater than 25 years.

How the Study Was Run

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

The participants were allocated by chance, so the Insulin Glargine group and the comparison group should start out alike.

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 2004-11 with completion listed for 2006-10.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: HbA1C.

It also tracked 1 secondary outcome, for example Glucose excursions.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin Glargine in 60 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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