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Trial · NCT02375828

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

NCT02375828, Phase 3, Completed, Assistance Publique - Hôpitaux de Paris

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Glibentek in Patients With Neonatal Diabetes Secondary to Mutations in K+-ATP Channels. Trials, record NCT02375828. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02375828

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
Glibentek in Patients With Neonatal Diabetes Secondary to Mutations in K+-ATP Channels
NCT number
NCT02375828
Status
Completed
Phases
Phase 3
Enrollment
10 participants, actual
Lead sponsor
Assistance Publique - Hôpitaux de Paris
Conditions
Neonatal Diabetes Secondary to Mutation in the Potassium Channel
Interventions
Glibenclamide
First posted
2015-03-03
Last updated
2025-09-08

Source ClinicalTrials.gov

Registered outcomes9

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryAcceptability of an oral solution of glibenclamide (Hedonic visual scale)2 months after the change from pills to oral solution.Hedonic visual scale
PrimaryAcceptability of an oral solution of glibenclamide (Hedonic visual scale)3 months after the change from pills to oral solution.Hedonic visual scale
SecondaryTolerance of an oral solution of glibenclamide (Self administrated questionnaries)2 months after the change from pills to oral solution.Self administrated questionnaries, liver and renal biology
SecondaryTolerance of an oral solution of glibenclamide (Self administrated questionnaries)3 months after the change from pills to oral solution.Self administrated questionnaries, liver and renal biology
SecondaryRecording pharmaceutical data on pills and oral solution of glibenclamide (Blood drug dosage)At inclusionBlood drug dosage
SecondaryRecording pharmaceutical data on pills and oral solution of glibenclamide (Blood drug dosage)2 months after the switch from pills to oral solutionBlood drug dosage
SecondaryNo alteration in metabolic control of the diseaseDuring the first month of administration
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
SecondaryNo alteration in metabolic control of the disease2 months after the change from pills to oral solution
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
SecondaryNo alteration in metabolic control of the disease3 months after the change from pills to oral solution
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

Outcomes0

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

None in this release.

Results by group0

Each measurement the trial posted, group by group, in the words and numbers it posted.

None in this release.

Participant flow0

How many started, completed or left each group, period by period.

None in this release.

Adverse events0

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

None in this release.

Adverse event totals0

The totals the trial posted for each group.

None in this release.

Papers4

The papers the trial lists on ClinicalTrials.gov.

PMIDListed asSource
16885549BACKGROUNDPubMed
16885550BACKGROUNDPubMed
24622368BACKGROUNDPubMed
30684309RESULTPubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT02375828

GET https://conductscience.org/api/trials/v1/NCT02375828/registered