| Trial ID: | L6040 |
| Source ID: | NCT00610038
|
| Associated Drug: |
Glibenclamide
|
| Title: |
Efficacy and Safety Study of Sulfonylureas in Neonatal Diabetes Mellitus
|
| Acronym: |
GLIDKIR6-2
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Mellitus
|
| Interventions: |
DRUG: glibenclamide
|
| Outcome Measures: |
Primary: assess continuously the capillary glycaemia for three consecutive days and evaluate the insulin secretion under insulin and sulfonylureas, permanent | Secondary: Rate the neurological and developmental status of the patients to seek for a potential improvement under glibenclamide therapy, every year|To assess the kinetics of glibenclamide in children, at the end of study
|
| Sponsor/Collaborators: |
Sponsor: Assistance Publique - Hôpitaux de Paris
|
| Gender: |
ALL
|
| Age: |
CHILD, ADULT, OLDER_ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
19
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2006-07
|
| Completion Date: |
2011-12
|
| Results First Posted: |
|
| Last Update Posted: |
2012-11-19
|
| Locations: |
Necker Hospital - Endocrinology Gynecology Pediatric unit, Paris, 75015, France
|
| URL: |
https://clinicaltrials.gov/show/NCT00610038
|