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

This study has been terminated.
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Rabin Medical Center
ClinicalTrials.gov Identifier:
NCT00925977
First received: June 22, 2009
Last updated: June 4, 2012
Last verified: June 2012

June 22, 2009
June 4, 2012
July 2009
February 2012   (final data collection date for primary outcome measure)
Treatment satisfaction [ Time Frame: patients will complete DTSQ at months 0,12 and 24 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00925977 on ClinicalTrials.gov Archive Site
  • HbA1c [ Time Frame: value of Hba1C will be measured at screening visit and at the end of each study arm ] [ Designated as safety issue: No ]
  • 4 and 7 points glucose profile [ Time Frame: patients will complete a diary before all clinical visits ] [ Designated as safety issue: No ]
  • Insulin doses [ Time Frame: Insulin doses will be determined at baseline visit and every visit after ] [ Designated as safety issue: No ]
  • Hypoglycemic events [ Time Frame: patients will report in their diary every episode of hypoglycemia ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
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

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Diabetes Type 1
  • 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
  • Active Comparator: insulin Glargine + insulin Apidra
    insulin Glargine + insulin Apidra
    Intervention: Drug: insulin Glargine + Insulin Apidra
  • Active Comparator: Insulin NPH + Insulin Apidra
    12 weeks treatment with Insulin NPH + Insulin Apidra
    Intervention: Drug: Insulin NPH + Insulin Apidra: Active Comparator
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
44
February 2012
February 2012   (final data collection date for primary outcome measure)

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.
Both
7 Years to 20 Years
No
Contact information is only displayed when the study is recruiting subjects
Israel
 
NCT00925977
rmc005275ctil
No
Rabin Medical Center
Rabin Medical Center
Sanofi
Principal Investigator: Moshe Phillip, Professor Rabin Medical Center
Rabin Medical Center
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP