This trial is terminated!
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More info
You can access this
clinical trial
if you have
Diabetes Type 1
and you are
between 7 and 20
years old
-
The phase for this study is not defined.
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The purpose

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. Patients will complete DTSQ (Diabetes Treatment Satisfaction Questionnaire) at months 0, 12 and 24 weeks, before and at the end of each study arm.

Provided treatments

  • Drug: insulin Glargine + Insulin Apidra
  • Drug: Insulin NPH + Insulin Apidra: Active Comparator
Tris trial is registered with FDA with number: NCT00925977. The sponsor of the trial is Rabin Medical Center and it is looking for 44 volunteers for the current phase.
Official trial title:
Treatment Satisfaction of Insulin Glargine Plus Insulin Apidra Compared With NPH Insulin Plus Insulin Apidra in Recently Diagnosed Type 1 Diabetes Children and Adolescents