Comparison of the Ability of Glulisine With Lispro to Control Type 1 Diabetes Mellitus in Children and Adolescents

What Was Tested

In this phase 3 trial, researchers set out to test Insulin Glargine and Insulin Lispro.

It had two arms (groups): Insulin Glulisine (experimental) and Insulin Lispro (active comparator).

Insulin Glulisine (100UI/ml), at least twice daily, in association with basal insulin therapy (NPH insulin or insulin glargine for a maximum of 26 weeks.

Insulin Lispro (100UI/ml) Subcutaneous (SC) injection , at least twice daily, in association with basal insulin therapy (NPH insulin or insulin glargine ) for a maximum of 30 weeks.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 572 actual participants took part.

It was open to people of any sex aged from 4 years up to 17 years.

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

Examples of who could join: Girls/boys, 4-17 years, inclusive;. Girls not yet of childbearing potential or, if sexually active, agree to use reliable medically accepted contraceptive measure during study;. Onset of diabetes at least 1 year prior to visit 1 (V1) of study;. Uninterrupted insulin therapy for at least 1 year before V1 of study;. At V1, on stable insulin regimen of either NPH or insulin glargine as basal insulin and willing to have multiple daily injections of insulin;.

The full record lists 8 inclusion and 27 exclusion criteria; among the exclusions: diabetes other than type 1 diabetes mellitus;; pregnancy (positive pregnancy blood test at v1) or breastfeeding;; pancreatectomized subjects;.

How the Study Was Run

Design: 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 2005-04 with completion listed for 2006-11.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change in total glycated hemoglobin measured as HbA1c equivalents (GHb )from baseline to endpoint (time frame: week 26 or last observed treatment).

It also tracked 4 secondary outcomes, for example Change from Baseline in GHb at weeks 12 and 26, Change from Baseline in Self-monitored glucose parameters and Incidence of Symptomatic hypoglycemia.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin Glargine and Insulin Lispro in 572 people.

With 572 participants it is a large trial for this field.

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 and the Insulin Lispro compound page, all human trials.