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

Clalit Health Services

Status: Terminated

Conditions: Diabetes Type 1

Treatments: Drug: insulin Glargine + Insulin Apidra; Drug: Insulin NPH + Insulin Apidra: Active Comparator

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00925977

rmc005275ctil

Details and patient eligibility

About

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.

Full 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.

Enrollment: 44 patients

Sex: All

Ages: 7 to 20 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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44 participants in 2 patient groups

insulin Glargine + insulin Apidra

Active Comparator group

Description:

insulin Glargine + insulin Apidra

Treatment:

Drug: insulin Glargine + Insulin Apidra

Insulin NPH + Insulin Apidra

Active Comparator group

Description:

12 weeks treatment with Insulin NPH + Insulin Apidra

Treatment:

Drug: Insulin NPH + Insulin Apidra: Active Comparator