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

Sponsor:	Rabin Medical Center
Collaborator:	Sanofi-Aventis
Information provided by (Responsible Party):	Rabin Medical Center
ClinicalTrials.gov Identifier:	NCT00925977

Purpose

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.

Condition	Intervention
Diabetes Type 1	Drug: insulin Glargine + Insulin Apidra Drug: Insulin NPH + Insulin Apidra: Active Comparator

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment
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

Resource links provided by NLM:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

MedlinePlus related topics: Diabetes Medicines Diabetes Type 1

Drug Information available for: Insulin Insulin beef Insulin, isophane Insulin glargine Insulin glulisine

U.S. FDA Resources

Further study details as provided by Rabin Medical Center:

Primary Outcome Measures:

Treatment satisfaction [ Time Frame: patients will complete DTSQ at months 0,12 and 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	134
Study Start Date:	July 2009
Estimated Study Completion Date:	February 2012
Estimated Primary Completion Date:	February 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: insulin Glargine + insulin Apidra 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

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

Ages Eligible for Study:	7 Years to 20 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00925977

Contacts

Contact: Moshe Phillip, Prof.

972-3-9253778

mosheph@clalit.org.il

Locations

Israel
Soroka hospital	Recruiting
Bear Sheva, Israel
Contact: Eli Hershkovitz, Prof 972-8-6400624 elih@bgu.ac.il
Principal Investigator: Eli Hershkovitz, Prof
Rambam Hospital	Recruiting
Haifa, Israel
Contact: Naim Shehadeh, Prof 972-4-8541935 n_shehadeh@rambam.health.gov.il
Principal Investigator: Naim Shehadeh, Prof
Health care unit- Jerusalem	Recruiting
Jerusalem, Israel
Contact: David Shtrich, Dr 972-2-6706606 dstrich@clalit.org.il
Principal Investigator: David Shtrich, Dr
Schnider children medical center	Recruiting
Petach-Tikva, Israel
Contact: Moshe Phillip, Professor 972-3-9253778 mosheph@clalit.org.il
Sub-Investigator: Shlomit Shalitin, Dr.
Sub-Investigator: Liat De Vries, Dr.
Sub-Investigator: Liora Lazar, Dr.
Sub-Investigator: Yael Levental, Dr.
Sub-Investigator: Tal Oron, Dr.
Sub-Investigator: Ravital Nimri, Dr.
Sub-Investigator: Ariel Tenenbaum, Dr.
Sub-Investigator: Tal Ben-Ari, Dr.
Sub-Investigator: Rachel Frumkin, Dr.
Sub-Investigator: Sharon Demol, Dr.

Sponsors and Collaborators

Rabin Medical Center

Sanofi-Aventis

Investigators

Principal Investigator:

Moshe Phillip, Professor

Rabin Medical Center

More Information

No publications provided

Responsible Party:	Rabin Medical Center
ClinicalTrials.gov Identifier:	NCT00925977 History of Changes
Other Study ID Numbers:	rmc005275ctil
Study First Received:	June 22, 2009
Last Updated:	November 1, 2011
Health Authority:	Israel: "Clalit Health Services"

Keywords provided by Rabin Medical Center:

treatment satisfaction
insulin Glargine
insulin Apidra
NPH insulin

Additional relevant MeSH terms:

Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Glargine

Insulin glulisine
Insulin
Insulin, NPH
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012