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

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

Sponsors

Lead Sponsor: Rabin Medical Center

Collaborator: Sanofi

Source Rabin Medical Center
Brief 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.

Overall Status Terminated
Start Date July 2009
Completion Date February 2012
Primary Completion Date February 2012
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Treatment satisfaction patients will complete DTSQ at months 0,12 and 24
Secondary Outcome
Measure Time Frame
HbA1c value of Hba1C will be measured at screening visit and at the end of each study arm
4 and 7 points glucose profile patients will complete a diary before all clinical visits
Insulin doses Insulin doses will be determined at baseline visit and every visit after
Hypoglycemic events patients will report in their diary every episode of hypoglycemia
Enrollment 44
Condition
Intervention

Intervention Type: Drug

Intervention Name: insulin Glargine + Insulin Apidra

Description: 12 wees treatment with Insulin Glargine + Insulin Apidra

Arm Group Label: insulin Glargine + insulin Apidra

Intervention Type: Drug

Intervention Name: Insulin NPH + Insulin Apidra: Active Comparator

Description: Insulin NPH + Insulin Apidra: Active Comparator

Arm Group Label: Insulin NPH + Insulin Apidra

Eligibility

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.

Gender: All

Minimum Age: 7 Years

Maximum Age: 20 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Moshe Phillip, Professor Principal Investigator Rabin Medical Center
Location
Facility:
Soroka hospital | Bear Sheva, Israel
Rambam Hospital | Haifa, Israel
Health care unit- Jerusalem | Jerusalem, Israel
Schnider children medical center | Petach-Tikva, Israel
Location Countries

Israel

Verification Date

June 2012

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: insulin Glargine + insulin Apidra

Type: Active Comparator

Description: insulin Glargine + insulin Apidra

Label: Insulin NPH + Insulin Apidra

Type: Active Comparator

Description: 12 weeks treatment with Insulin NPH + Insulin Apidra

Study Design Info

Allocation: Randomized

Intervention Model: Crossover Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov