Status:
COMPLETED
Efficacy and Safety Study of Sulfonylureas in Neonatal Diabetes Mellitus
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborating Sponsors:
URC-CIC Paris Descartes Necker Cochin
Conditions:
Diabetes Mellitus
Eligibility:
All Genders
Phase:
PHASE2
Brief Summary
The aim of our trial is to try to switch patients with permanent neonatal diabetes mellitus due to a Kir6.2 or SUR1 activating mutation from subcutaneous insulin to oral glibenclamide therapy.
Detailed Description
Neonatal diabetes mellitus, characterized by hyperglycaemia requiring exogenous insulin therapy appearing during the first months of life, is a rare condition with an estimated incidence of 1 in 40000...
Eligibility Criteria
Inclusion
- coding sequence of KCNJ11 or ABCC8 in patients having a permanent neonatal diabetes mellitus
- written informed consent
Exclusion
- hypersensibility of sulfonylureas
- severe renal failure (clearance of creatinemia \< 30 ml/min)
- severe hepatic failure (Prothrombin rate \< 70 %)
- Porphyria
- imidazol treatments
- pregnancy
- no social security affiliation
Key Trial Info
Start Date :
July 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT00610038
Start Date
July 1 2006
End Date
December 1 2011
Last Update
November 20 2025
Active Locations (1)
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1
Necker Hospital - Endocrinology Gynecology Pediatric unit
Paris, France, 75015