Glibentek in Patients With Neonatal Diabetes Secondary to Mutations in K+-ATP Channels

• Status: Completed
• Trial end date: 2019-07-22
• Target enrollment: 0
• Participant gender: All

Summary

The understanding of the molecular mechanisms of neonatal diabetes has deeply changed the therapy of patients carrying mutations in the K-ATP channel. Indeed, those patients are not treated anymore by insulin injections but by glibenclamide an oral anti-diabetic drug widely used in type 2 diabetes. Anyway, its galenic form (pills of 5 mg) is not suitable for children and difficult to administrate to infants or young children. The purpose of this study is to determine if a new galenic form of this durg is more suitable and as efficient as pills in children with neonatal diabetes.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

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

Criteria

Inclusion Criteria:

• Age below 18 years

• Neonatal diabetes secondary to documented mutation in one of the 2 sub units of potassium channels

• Patients already treated by glibenclamide pills

• Signed consent

Exclusion Criteria:

• Families unable to fill in the questionnaries

• Patients unable to answer to the visual hedonic squale

• Patients unable to take the oral solution

• Known allergy to sulfonylureas or to other antidiabetic or antibiotic sulfamides

• Insulin therapy associated to glibenclamide

• Miconazole therapy

• Porphyria

• Breast feeding

• Severe renal failure (creatinine clearance below 30 ml/mn)

• Liver failure (prothombine time below 70)

• Not affiliated to the health care system