NCT00925977

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: Rabin Medical Center · Academic / Other
• Sex: All
• Age: 7 Years – 20 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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. 134 Patients with new onset Diabetes type 1, diagnosed 12 months previously at maximum will be enrolled. 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 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. Height,weight,vital signs, HbA1c and insulin doses will be determined during the clinical visits. Patients will complete DTSQ (Diabetes Treatment Satisfaction Questionnaire) at months 0, 12 and 24 weeks, before and at the end of each study arm. The DTSQ questionnaires consists of DTSQ parents- for patients below the age of 13, and DTSQ teen for those above age 13.

Conditions

• Diabetes Type 1

Interventions

Type	Name	Description
DRUG	insulin Glargine + Insulin Apidra	12 wees treatment with Insulin Glargine + Insulin Apidra
DRUG	Insulin NPH + Insulin Apidra: Active Comparator	Insulin NPH + Insulin Apidra: Active Comparator

Timeline

• Start date: 2009-07-01
• Primary completion: 2012-02-01
• Completion: 2012-02-01
• First posted: 2009-06-23
• Last updated: 2012-06-05

Locations

4 sites across 1 country: Israel