Treatment Satisfaction of Insulin Glargine Plus Insulin Apidra Compared With NPH Insulin Plus Insulin Apidra in Recently Diagnosed Type 1 Diabetes Children and Adolescents

What Was Tested

The trial (not phased) is built around Insulin Glargine and NPH Insulin (isophane).

A randomized, crossover, open study in order to compare treatment satisfaction with insulin Glargine plus insulin Apidra Vs NPH insulin plus insulin Apidra in newly diagnosed children and adolescents with type 1 diabetes.

The study will include two consecutive periods: 2 weeks run in period and 24 weeks intervention period, divided into two separate treatment periods of 12 weeks.

According to randomization, each patient will be treated consecutively with both treatment arms: 12 weeks with insulin Glargine and than 12 weeks with NPH insulin or 12 weeks with insulin NPH ad than 12 weeks with insulin Glargine.

It had two arms (groups): insulin Glargine + insulin Apidra (active comparator) and Insulin NPH + Insulin Apidra (active comparator).

Insulin Glargine + insulin Apidra.

12 weeks treatment with Insulin NPH + Insulin Apidra.

The registry classes the interventions as drug.

More on the Plan

According to randomization, each patient will be treated consecutively with both treatment arms: 12 weeks with insulin Glargine and than 12 weeks with NPH insulin or 12 weeks with NPH insulin and than 12 weeks with insulin Glargine.

The study will consist of 4 clinical visits, taking place at -2, 0, 12 and 24 weeks.

The DTSQ questionnaires consists of DTSQ parents- for patients below the age of 13, and DTSQ teen for those above age 13.

Who Took Part

Enrollment: 44 actual participants took part.

It was open to people of any sex aged from 7 years up to 20 years.

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

Examples of who could join: Type 1 diabetes diagnosed less than 12 months prior to study entry. Age: 7-20 years old. Signing inform consent form.

The full record lists 4 inclusion and 4 exclusion criteria; among the exclusions: patients participating in other device or drug studies; any contraindication to insulin glargine and or insulin apidra and or insulin nph according to smpc; inability, of adolescent or parent, to understand/complete the treatment satisfaction questionnaire.

How the Study Was Run

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

Because people in this Insulin Glargine study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

In the crossover set-up each of the participants took both Insulin Glargine and the comparison in turn, acting as their own control.

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

It started in 2009-07 with completion listed for 2012-02.

It ran at 4 sites in Israel (4).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Treatment satisfaction (time frame: patients will complete DTSQ at months 0,12 and 24).

It also tracked 4 secondary outcomes, for example HbA1c, 4 and 7 points glucose profile and Hypoglycemic events.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Insulin Glargine and NPH Insulin (isophane) in 44 people.

It ended early (terminated); no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Insulin Glargine compound page and the NPH Insulin (isophane) compound page, all human trials.