Efficacy and Safety Study of Sulfonylureas in Neonatal Diabetes Mellitus

• Status: Completed
• Trial end date: 2011-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Treatments: Glyburide

Criteria

Inclusion Criteria:

• coding sequence of KCNJ11 or ABCC8 in patients having a permanent neonatal diabetes mellitus

• written informed consent

Exclusion Criteria:

• 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