Clinical trial 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
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Diabetes Type 1
Keywords: treatment satisfaction
insulin Glargine
insulin Apidra
NPH insulin
Lead sponsor: Rabin Medical Center
Sponsor class: OTHER
Collaborators: name: Sanofi
First posted: 2009-06-23
Enrollment: 44
Sex: ALL
Minimum age (years): 7
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Treatment satisfaction
timeFrame: patients will complete DTSQ at months 0,12 and 24
Secondary outcomes:
measure: HbA1c
timeFrame: value of Hba1C will be measured at screening visit and at the end of each study arm
measure: 4 and 7 points glucose profile
timeFrame: patients will complete a diary before all clinical visits
measure: Insulin doses
timeFrame: Insulin doses will be determined at baseline visit and every visit after
measure: Hypoglycemic events
timeFrame: patients will report in their diary every episode of hypoglycemia
Other outcomes:
Locations:
city: Bear Sheva
country: Israel
facility: Soroka hospital
city: Haifa
country: Israel
facility: Rambam Hospital
city: Jerusalem
country: Israel
facility: Health care unit- Jerusalem
city: Petach-Tikva
country: Israel
facility: Schnider children medical center
Study officials:
affiliation: Rabin Medical Center
name: Moshe Phillip, Professor
role: PRINCIPAL_INVESTIGATOR
References: