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.

Study Overview

• Status: Terminated
• Conditions: Diabetes Type 1
• Intervention / Treatment: Drug: insulin Glargine + Insulin Apidra; Drug: Insulin NPH + Insulin Apidra: Active Comparator

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.

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Bear Sheva, Israel
    • Soroka Hospital
  • Haifa, Israel
    • Rambam Hospital
  • Jerusalem, Israel
    • Health care unit- Jerusalem
  • Petach-Tikva, Israel
    • Schnider children medical center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 16 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: insulin Glargine + insulin Apidra	Drug: insulin Glargine + Insulin Apidra; 12 wees treatment with Insulin Glargine + Insulin Apidra
Active Comparator: Insulin NPH + Insulin Apidra; 12 weeks treatment with Insulin NPH + Insulin Apidra	Drug: Insulin NPH + Insulin Apidra: Active Comparator; Insulin NPH + Insulin Apidra: Active Comparator

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Treatment satisfaction	patients will complete DTSQ at months 0,12 and 24

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Rabin Medical Center
• Collaborators: Sanofi

Study record dates

Study Major Dates

• Study Start: July 1, 2009
• Primary Completion (Actual): February 1, 2012
• Study Completion (Actual): February 1, 2012

Study Registration Dates

• First Submitted: June 22, 2009
• First Submitted That Met QC Criteria: June 22, 2009
• First Posted (Estimate): June 23, 2009

Study Record Updates

• Last Update Posted (Estimate): June 5, 2012
• Last Update Submitted That Met QC Criteria: June 4, 2012
• Last Verified: June 1, 2012

More Information

Terms related to this study

• Keywords: treatment satisfaction; insulin Glargine; insulin Apidra; NPH insulin
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1; Hypoglycemic Agents; Physiological Effects of Drugs; Insulin; Insulin, Globin Zinc; Insulin Glargine; Insulin glulisine; Insulin, Isophane; Isophane Insulin, Human; Isophane insulin, beef
• Other Study ID Numbers: rmc005275ctil