| Trial ID: | L5316 |
| Source ID: | NCT00542399
|
| Associated Drug: |
Levemir (Insulin Detemir)
|
| Title: |
Comparing the Metabolic Control of Once to Twice-daily Insulin Detemir Injections
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 1 Diabetes Mellitus
|
| Interventions: |
DRUG: Levemir (insulin detemir)|DRUG: Levemir twice a day
|
| Outcome Measures: |
Primary: HbA1C, at screening visit, at the middle of the study, at the end of the study and prior to sweetching to twice daily treatment|SBGM, 4-8 times a day|CGMS, 72 hours prior to switching to twice daily treatment and at the end of study|Total daily basal and bolus insulin, will be calculated every visit | Secondary: documentation of hypoglycemic and hyperglycemic episodes, diary will be collected every visit
|
| Sponsor/Collaborators: |
Sponsor: Rabin Medical Center
|
| Gender: |
ALL
|
| Age: |
CHILD, ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
50
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: NON_RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2007-11
|
| Completion Date: |
2010-03
|
| Results First Posted: |
|
| Last Update Posted: |
2011-11-02
|
| Locations: |
Schneider Children's Medical Center, Petach-Tikva, Israel
|
| URL: |
https://clinicaltrials.gov/show/NCT00542399
|
