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

NCT00925977 | Terminated

• 1 other identifier: rmc005275ctil
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 4

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.

Conditions

Diabetes Type 1

Keywords

treatment satisfaction; insulin Glargine; insulin Apidra; NPH insulin

Outcome Measures

Primary Outcomes (1)

• Treatment satisfaction

  patients will complete DTSQ at months 0,12 and 24

Secondary Outcomes (4)

• 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

Study Arms (2)

insulin Glargine + insulin Apidra

ACTIVE COMPARATOR

insulin Glargine + insulin Apidra

Drug: insulin Glargine + Insulin Apidra

Insulin NPH + Insulin Apidra

ACTIVE COMPARATOR

12 weeks treatment with Insulin NPH + Insulin Apidra

Drug: Insulin NPH + Insulin Apidra: Active Comparator

Interventions

insulin Glargine + Insulin Apidra DRUG

12 wees treatment with Insulin Glargine + Insulin Apidra

insulin Glargine + insulin Apidra

Insulin NPH + Insulin Apidra: Active Comparator DRUG

Insulin NPH + Insulin Apidra: Active Comparator

Insulin NPH + Insulin Apidra

Eligibility Criteria

• Age: 7 Years - 20 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Type 1 diabetes diagnosed less than 12 months prior to study entry
• Age: 7-20 years old.
• HbA1c\>/=8.0
• Signing inform consent form

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rabin Medical Center: lead
• Sanofi: collaborator

Study Sites (4)

Soroka hospital

Bear Sheva, Israel

Location

Rambam Hospital

Haifa, Israel

Location

Health care unit- Jerusalem

Jerusalem, Israel

Location

Schnider children medical center

Petah Tikva, Israel

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Insulin Glargine; Insulin, Isophane

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Moshe Phillip, Professor

  Rabin Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2009
• First Posted: June 23, 2009
• Study Start: July 1, 2009
• Primary Completion: February 1, 2012
• Study Completion: February 1, 2012
• Last Updated: June 5, 2012

Record last verified: 2012-06

Locations

IL (4)