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

Primary Purpose

Diabetes Type 1

Status
Terminated
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
insulin Glargine + Insulin Apidra
Insulin NPH + Insulin Apidra: Active Comparator
Sponsored by
Rabin Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Type 1 focused on measuring treatment satisfaction, insulin Glargine, insulin Apidra, NPH insulin

Eligibility Criteria

7 Years - 20 Years (Child, Adult)All SexesDoes not accept 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.

Sites / Locations

  • Soroka hospital
  • Rambam Hospital
  • Health care unit- Jerusalem
  • Schnider children medical center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

insulin Glargine + insulin Apidra

Insulin NPH + Insulin Apidra

Arm Description

insulin Glargine + insulin Apidra

12 weeks treatment with Insulin NPH + Insulin Apidra

Outcomes

Primary Outcome Measures

Treatment satisfaction

Secondary Outcome Measures

HbA1c
4 and 7 points glucose profile
Insulin doses
Hypoglycemic events

Full Information

First Posted
June 22, 2009
Last Updated
June 4, 2012
Sponsor
Rabin Medical Center
Collaborators
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT00925977
Brief 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
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

2. Study Status

Record Verification Date
June 2012
Overall Recruitment Status
Terminated
Study Start Date
July 2009 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
February 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rabin Medical Center
Collaborators
Sanofi

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Type 1
Keywords
treatment satisfaction, insulin Glargine, insulin Apidra, NPH insulin

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
insulin Glargine + insulin Apidra
Arm Type
Active Comparator
Arm Description
insulin Glargine + insulin Apidra
Arm Title
Insulin NPH + Insulin Apidra
Arm Type
Active Comparator
Arm Description
12 weeks treatment with Insulin NPH + Insulin Apidra
Intervention Type
Drug
Intervention Name(s)
insulin Glargine + Insulin Apidra
Intervention Description
12 wees treatment with Insulin Glargine + Insulin Apidra
Intervention Type
Drug
Intervention Name(s)
Insulin NPH + Insulin Apidra: Active Comparator
Intervention Description
Insulin NPH + Insulin Apidra: Active Comparator
Primary Outcome Measure Information:
Title
Treatment satisfaction
Time Frame
patients will complete DTSQ at months 0,12 and 24
Secondary Outcome Measure Information:
Title
HbA1c
Time Frame
value of Hba1C will be measured at screening visit and at the end of each study arm
Title
4 and 7 points glucose profile
Time Frame
patients will complete a diary before all clinical visits
Title
Insulin doses
Time Frame
Insulin doses will be determined at baseline visit and every visit after
Title
Hypoglycemic events
Time Frame
patients will report in their diary every episode of hypoglycemia

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Type 1 diabetes diagnosed less than 12 months prior to study entry Age: 7-20 years old. HbA1c>/=8.0 Signing inform consent form Exclusion Criteria: 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. Patients participating in other device or drug studies. Any contraindication to insulin glargine and or insulin Apidra and or Insulin NPH according to SmPC. Inability, of adolescent or parent, to understand/complete the Treatment satisfaction questionnaire.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Moshe Phillip, Professor
Organizational Affiliation
Rabin Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Soroka hospital
City
Bear Sheva
Country
Israel
Facility Name
Rambam Hospital
City
Haifa
Country
Israel
Facility Name
Health care unit- Jerusalem
City
Jerusalem
Country
Israel
Facility Name
Schnider children medical center
City
Petach-Tikva
Country
Israel

12. IPD Sharing Statement

Learn more about this trial

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

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