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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00925977
• Date of registration: 22/06/2009
• Prospective Registration: Yes
• Primary sponsor: Rabin Medical Center
• Public 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
• Scientific 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
• Date of first enrolment: July 2009
• Target sample size: 44
• Recruitment status: Terminated
• URL: http://clinicaltrials.gov/show/NCT00925977
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: N/A

Countries of recruitment

Israel

Contacts

• Name: Moshe Phillip, Professor
• Affiliation: Rabin Medical Center

Key inclusion & exclusion criteria

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.



Age minimum: 7 Years
Age maximum: 20 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Diabetes Type 1

Intervention(s)

Drug: insulin Glargine + Insulin Apidra

Drug: Insulin NPH + Insulin Apidra: Active Comparator

Primary Outcome(s)

Treatment satisfaction [Time Frame: patients will complete DTSQ at months 0,12 and 24]

Secondary Outcome(s)

Hypoglycemic events [Time Frame: patients will report in their diary every episode of hypoglycemia]

Insulin doses [Time Frame: Insulin doses will be determined at baseline visit and every visit after]

4 and 7 points glucose profile [Time Frame: patients will complete a diary before all clinical visits]

HbA1c [Time Frame: value of Hba1C will be measured at screening visit and at the end of each study arm]

Secondary ID(s)

rmc005275ctil

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Sanofi