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

Diabetes Type 1 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00925977
• Other study ID #: rmc005275ctil
• Status: Terminated
• Phase: N/A
• First received: June 22, 2009
• Last updated: June 4, 2012
• Start date: July 2009
• Est. completion date: February 2012

Study information

• Verified date: June 2012
• Source: Rabin Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: "Clalit Health Services"
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 44
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 7 Years to 20 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Diabetes Type 1

Intervention

Drug:
• insulin Glargine + Insulin Apidra
12 wees treatment with Insulin Glargine + Insulin Apidra
• Insulin NPH + Insulin Apidra: Active Comparator
Insulin NPH + Insulin Apidra: Active Comparator

Locations

Country	Name	City	State
Israel	Soroka hospital	Bear Sheva
Israel	Rambam Hospital	Haifa
Israel	Health care unit- Jerusalem	Jerusalem
Israel	Schnider children medical center	Petach-Tikva

Sponsors (2)

Lead Sponsor	Collaborator
Rabin Medical Center	Sanofi

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment satisfaction		patients will complete DTSQ at months 0,12 and 24	No
Secondary	HbA1c		value of Hba1C will be measured at screening visit and at the end of each study arm	No
Secondary	4 and 7 points glucose profile		patients will complete a diary before all clinical visits	No
Secondary	Insulin doses		Insulin doses will be determined at baseline visit and every visit after	No
Secondary	Hypoglycemic events		patients will report in their diary every episode of hypoglycemia	Yes