Overview

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:

Participant gender:

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

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