Trial · NCT05687500
Oral Glibenclamide in Preterm Infants With Hyperglycaemia (GALOP)
NCT05687500, Phase 2, Completed, Assistance Publique - Hôpitaux de Paris
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. Oral Glibenclamide in Preterm Infants With Hyperglycaemia (GALOP). Trials, record NCT05687500. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05687500
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Oral Glibenclamide in Preterm Infants With Hyperglycaemia (GALOP)
- NCT number
- NCT05687500
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 35 participants, actual
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Conditions
- Transient; Hypoglycemia, Neonatal, Preterm, Glibenclamide Adverse Reaction
- Interventions
- Glibenclamide, Pharmacokinetics study, C-peptide proinsulin ratio, Routine biological monitoring
- First posted
- 2023-01-18
- Last updated
- 2026-10-02
- Other registries' IDs
- eudract:2021-005766-18
Source ClinicalTrials.gov
Registered outcomes33
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Blood glucose control | At 72 hours after the first administration | The primary evaluation criteria is 72 hours blood glucose control on glibenclamide treatment (success of the treatment). This is defined as the non-use of insulin and absence of severe hypoglycemia (\< 1.5 mmol/l) or persistent moderate hypoglycemia (\< 2.6 mmol/l in 2 successive measurements (dextro) at an interval of more than 3 hours) |
| Secondary | Overall success of the treatment | At 36 week of amenorrhea corrected age | Overall success of the treatment defined by continuation to the end of treatment without recourse to insulin. |
| Secondary | Blood glucose profile on glibenclamide | At the end of treatment assessed up to 15 days | Time between the start of glibenclamide treatment and the 1st blood glucose \< 10 mmol/l |
| Secondary | Blood glucose profile on glibenclamide | At the end of treatment assessed up to 15 days | Time between the start of glibenclamide treatment and the 1st blood glucose \< 8 mmol/l |
| Secondary | Blood glucose profile on glibenclamide | At the end of treatment assessed up to 15 days | Proportion of time spent within the target blood glucose range (≥ 4 and \< 10 mmol/l) during the period of glibenclamide treatment |
| Secondary | Blood glucose profile on glibenclamide | At the end of treatment assessed up to 15 days | Proportion of time spent above the target level (≥ 10 mmol/l) during the period of glibenclamide treatment |
| Secondary | Blood glucose profile on glibenclamide | At the end of treatment assessed up to 15 days | Proportion of time spent in hypoglycemia (\< 2.6 mmol/l) during the period of glibenclamide treatment |
| Secondary | Duration of glibenclamide treatment | At the end of treatment assessed up to 15 days | Duration of glibenclamide treatment. |
| Secondary | Nutritional intakes and growth | At the end of treatment assessed up to 15 days | Carbohydrate |
| Secondary | Nutritional intakes and growth: | At the end of treatment assessed up to 15 days | lipid |
1 to 10 of 33Source ClinicalTrials.gov
See all 33 registered outcomesOutcomes0
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.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone 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/NCT05687500
GET https://conductscience.org/api/trials/v1/NCT05687500/registered?page=2