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Clinical Trial Details

Trial ID: L6403
Source ID: NCT02375828
Associated Drug: Glibenclamide
Title: Glibentek in Patients With Neonatal Diabetes Secondary to Mutations in K+-ATP Channels
Acronym: NEOGLI
Status: COMPLETED
Study Results: NO
Results:
Conditions: Neonatal Diabetes Secondary to Mutation in the Potassium Channel
Interventions: DRUG: Glibenclamide
Outcome Measures: Primary: Acceptability of an oral solution of glibenclamide (Hedonic visual scale), Hedonic visual scale, 2 months after the change from pills to oral solution.|Acceptability of an oral solution of glibenclamide (Hedonic visual scale), Hedonic visual scale, 3 months after the change from pills to oral solution. | Secondary: Tolerance of an oral solution of glibenclamide (Self administrated questionnaries), Self administrated questionnaries, liver and renal biology, 2 months after the change from pills to oral solution.|Tolerance of an oral solution of glibenclamide (Self administrated questionnaries), Self administrated questionnaries, liver and renal biology, 3 months after the change from pills to oral solution.|Recording pharmaceutical data on pills and oral solution of glibenclamide (Blood drug dosage), Blood drug dosage, At inclusion|Recording pharmaceutical data on pills and oral solution of glibenclamide (Blood drug dosage), Blood drug dosage, 2 months after the switch from pills to oral solution|No alteration in metabolic control of the disease, HbA1C at month 3, fructosamine at month 2 and 3, self record of hypoglycaemia during month 1, 2 and 3, glycemia before and after meals during 2 consecutive days at introduction of oral solution and during 2 meals at month 2 and month 3, During the first month of administration|No alteration in metabolic control of the disease, HbA1C at month 3, fructosamine at month 2 and 3, self record of hypoglycaemia during month 1, 2 and 3, glycemia before and after meals during 2 consecutive days at introduction of oral solution and during 2 meals at month 2 and month 3, 2 months after the change from pills to oral solution|No alteration in metabolic control of the disease, HbA1C at month 3, fructosamine at month 2 and 3, self record of hypoglycaemia during month 1, 2 and 3, glycemia before and after meals during 2 consecutive days at introduction of oral solution and during 2 meals at month 2 and month 3, 3 months after the change from pills to oral solution
Sponsor/Collaborators: Sponsor: Assistance Publique - Hôpitaux de Paris
Gender: ALL
Age: CHILD, ADULT
Phases: PHASE3
Enrollment: 10
Study Type: INTERVENTIONAL
Study Designs: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2015-03-20
Completion Date: 2019-07-22
Results First Posted:
Last Update Posted: 2019-08-30
Locations: Hôpital Universitaire Necker Enfants Malades, Paris, 7501, France
URL: https://clinicaltrials.gov/show/NCT02375828