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

PHASE3CompletedINTERVENTIONAL
Enrollment

10

Participants

Timeline

Start Date

March 20, 2015

Primary Completion Date

March 4, 2016

Study Completion Date

July 22, 2019

Conditions
Neonatal Diabetes Secondary to Mutation in the Potassium Channel
Interventions
DRUG

Glibenclamide

Glibenclamide pills will be administrated during one month at the previously used dosage. During the first month of the study we wwil record pharmacokinetic data, number of hypoglycaemia and the administration problems associated to this galenic form. At the end of the first month of enrolment, patients will be given oral solution of glibenclamide for the 4 remaining months. Pharmacocinetic data, number of hypoglycaemia and parents and children feeling about pratictability of administration will be then recorded.

Trial Locations (1)

7501

Hôpital Universitaire Necker Enfants Malades, Paris

All Listed Sponsors
collaborator

URC-CIC Paris Descartes Necker Cochin

OTHER

lead

Assistance Publique - Hôpitaux de Paris

OTHER

NCT02375828 - Glibentek in Patients With Neonatal Diabetes Secondary to Mutations in K+-ATP Channels | Biotech Hunter | Biotech Hunter