6-month Comparison of Morning Lantus Versus Neutral Protamine Hagedorn Insulin in Young Children With Type 1 Diabetes

What Was Tested

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

The primary study objective was to compare the rate of "all hypoglycemia" (composite outcome of the following hypoglycemia events: symptomatic hypoglycemia episodes, low continuous glucose monitoring system (CGMS) excursions confirmed by fingerstick blood glucose (FSBG), low FSBG readings performed at other times) between children treated with Lantus (insulin glargine) and Neutral Protamine Hagedorn (NPH) insulin.

It had two arms (groups): Lantus (insulin glargine) (experimental) and NPH insulin (active comparator).

Lantus given as basal insulin once a day in the morning by subcutaneous injection.

Neutral Protamine Hagedorn (NPH) human insulin given as basal insulin either once or twice per day generally in the morning and /or at bedtime by subcutaneous injection.

The registry classes the interventions as drug.

More on the Plan

Follow-up phase: 2 weeks All Phases: 28 to 30 weeks.

Who Took Part

125 actual participants took part.

It was open to people of any sex aged from 1 Year up to 6 years.

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

The full record lists 1 inclusion and 15 exclusion criteria; among the exclusions: diagnosis of type 1 diabetes for less than one year; diabetes other than type 1 diabetes; patients treated with insulin pump therapy during the two months prior to screening.

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.

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

Being open-label, the Insulin Glargine study did not mask who received what.

It started in 2009-10 with completion listed for 2011-03.

It ran at 61 sites in United States (8), Brazil (6), Hungary (5), India (5), Russia (5) and Chile (4).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Event Rate of "All Hypoglycemia" Defined as the Total Number of Episodes Divided by the Total Duration of the On-treatment Period in Years (Events Per Patient-year) (time frame: 6 months).

It also tracked 9 secondary outcomes, for example Glycosylated Hemoglobin A1c (HbA1c): End of Treatment and Change From Baseline to End of Treatment, Glycosylated Hemoglobin A1c (HbA1c): End of Treatment and Change From Baseline to End of Treatment (ANCOVA Estimates) and Average Daily Blood Glucose (BG) Based on CGMS Values: End of Treatment and Change From Baseline to End of Treatment.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin Glargine and Insulin Lispro in 125 people.

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

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