| Trial ID: | L7190 |
| Source ID: | NCT00925977
|
| Associated Drug: |
Insulin Glargine + Insulin Apidra
|
| 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
|
| Acronym: |
|
| Status: |
TERMINATED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Type 1
|
| Interventions: |
DRUG: insulin Glargine + Insulin Apidra|DRUG: Insulin NPH + Insulin Apidra: Active Comparator
|
| Outcome Measures: |
Primary: Treatment satisfaction, patients will complete DTSQ at months 0,12 and 24 | Secondary: 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
|
| Sponsor/Collaborators: |
Sponsor: Rabin Medical Center | Collaborators: Sanofi
|
| Gender: |
ALL
|
| Age: |
CHILD, ADULT
|
| Phases: |
|
| Enrollment: |
44
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2009-07
|
| Completion Date: |
2012-02
|
| Results First Posted: |
|
| Last Update Posted: |
2012-06-05
|
| Locations: |
Soroka hospital, Bear Sheva, Israel|Rambam Hospital, Haifa, Israel|Health care unit- Jerusalem, Jerusalem, Israel|Schnider children medical center, Petach-Tikva, Israel
|
| URL: |
https://clinicaltrials.gov/show/NCT00925977
|
