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

• Status: Terminated
• Trial end date: 2012-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rabin Medical Center
• Collaborator: Sanofi
• Treatments: Insulin; Insulin Glargine; Insulin glulisine; Insulin, Globin Zinc; Insulin, Isophane; Isophane insulin, beef; Isophane Insulin, Human

Criteria

Inclusion Criteria:

1. Type 1 diabetes diagnosed less than 12 months prior to study entry

2. Age: 7-20 years old.

3. HbA1c>/=8.0

4. Signing inform consent form

Exclusion Criteria:

1. Any significant disease or conditions, including psychiatric disorders that in the opinion of the investigator are likely to effect his compliance or ability to complete the study.

2. Patients participating in other device or drug studies.

3. Any contraindication to insulin glargine and or insulin Apidra and or Insulin NPH according to SmPC.

4. Inability, of adolescent or parent, to understand/complete the Treatment satisfaction questionnaire.