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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-005766-18 | EudraCT Number |
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| Name | Class |
|---|---|
| URC-CIC Paris Descartes Necker Cochin | OTHER |
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The purpose of this study is to confirm hypothesis that Glibenclamide can be administered orally and is an alternative to insulin therapy in treating transient hyperglycemia of premature newborns.
Transient hyperglycemia of premature newborns results from an overall decrease in insulin sensitivity, which is responsible at the beta cell level for abnormalities of intragranular cleavage of proinsulin into insulin, leading to reduced active insulin secretion. Intravenous administration of exogenous insulin can be used to combat insulin resistance and lower blood glucose, but it is difficult to manage in premature newborns and is associated with a substantial risk of hypoglycemia. Glibenclamide, which stimulates endogenous insulin secretion and can be administered orally, might be an alternative to insulin therapy in treating transient hyperglycemia of premature newborns.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Glibenclamide oral | Experimental | Amglidia®: glibenclamide oral suspension 6 mg/ml administered by gastric tube after dilution to 1/6th in human milk |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Glibenclamide | Drug | Amglidia®: glibenclamide oral suspension 6 mg/ml administered by gastric tube after dilution to 1/6th in human milk |
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| Measure | Description | Time Frame |
|---|---|---|
| Blood glucose control | 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) | At 72 hours after the first administration |
| Measure | Description | Time Frame |
|---|---|---|
| Overall success of the treatment | Overall success of the treatment defined by continuation to the end of treatment without recourse to insulin. | At 36 week of amenorrhea corrected age |
| Blood glucose profile on glibenclamide |
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Inclusion Criteria:
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Jacques BELTRAND, Pr | Assistance Publique - Hôpitaux de Paris | Study Director |
| Michel POLAK | Assistance Publique - Hôpitaux de Paris | Study Director |
| Delphine MITANCHEZ | CHRU de Tours | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hopital Necker - Enfants malades | Paris | 75015 | France |
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| ID | Term |
|---|---|
| D007003 | Hypoglycemia |
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D007752 | Obstetric Labor, Premature |
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| ID | Term |
|---|---|
| D005905 | Glyburide |
| ID | Term |
|---|---|
| D013453 | Sulfonylurea Compounds |
| D014508 | Urea |
| D000577 | Amides |
| D009930 | Organic Chemicals |
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| Pharmacokinetics study | Biological |
PK parameters of glibenclamide will be determined using nonlinear analysis: area under the plasma concentration time curve (AUC), absorption constant, apparent clearance and volume of distribution. |
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| C-peptide proinsulin ratio | Biological | blood sampling at before first administration and after 24 hours for measurement of C-peptide proinsulin ratio if it is impossible to collect both volumes, the C-peptide collection will be prioritized |
|
| Routine biological monitoring | Biological | If there are not performed as part of standard care, biological monitoring of ALT, AST, complete blood count, hemostasis, urea, creatinine, blood ionogram, total bilirubin and conjugated bilirubin will be done before first administration at the following time frame : 48 hours after the first administration than each days during treatment period, and 48 hours after the end of treatment. Transaminases and hemostasis will be done only in case of clinical indication before the first administration. |
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Time between the start of glibenclamide treatment and the 1st blood glucose < 10 mmol/l
| At the end of treatment assessed up to 15 days |
| Blood glucose profile on glibenclamide | Time between the start of glibenclamide treatment and the 1st blood glucose < 8 mmol/l | At the end of treatment assessed up to 15 days |
| Blood glucose profile on glibenclamide | Proportion of time spent within the target blood glucose range (≥ 4 and < 10 mmol/l) during the period of glibenclamide treatment | At the end of treatment assessed up to 15 days |
| Blood glucose profile on glibenclamide | Proportion of time spent above the target level (≥ 10 mmol/l) during the period of glibenclamide treatment | At the end of treatment assessed up to 15 days |
| Blood glucose profile on glibenclamide | Proportion of time spent in hypoglycemia (< 2.6 mmol/l) during the period of glibenclamide treatment | At the end of treatment assessed up to 15 days |
| Duration of glibenclamide treatment | Duration of glibenclamide treatment. | At the end of treatment assessed up to 15 days |
| Nutritional intakes and growth | Carbohydrate | At the end of treatment assessed up to 15 days |
| Nutritional intakes and growth: | lipid | At the end of treatment assessed up to 15 days |
| Nutritional intakes and growth: | protein | At the end of treatment assessed up to 15 days |
| Nutritional intakes and growth: | mean caloric intake (kcal/kg/day) during treatment | At the end of treatment assessed up to 15 days |
| Nutritional intakes and growth: | mean weight gain (g/kg/day) | At the end of treatment assessed up to 15 days |
| Nutritional intakes and growth | Carbohydrate | At 36 week of amenorrhea corrected age |
| Nutritional intakes and growth: | lipid | At 36 week of amenorrhea corrected age |
| Nutritional intakes and growth: | protein | At 36 week of amenorrhea corrected age |
| Nutritional intakes and growth: | mean caloric intake (kcal/kg/day) during treatment | At 36 week of amenorrhea corrected age |
| Nutritional intakes and growth: | mean weight gain ((g/kg/day) | At 36 week of amenorrhea corrected age |
| Number of children with episode of hypoglycemia | Number of children with at least one episode of moderate (blood glucose < 2.6 mmol/l) or severe (< 1.5 mmol/l) hypoglycemia | At 72 hours after first administration |
| Number of children with episode of hypoglycemia | Number of children with at least one episode of moderate (blood glucose < 2.6 mmol/l) or severe (< 1.5 mmol/l) hypoglycemia | At the end of treatment assessed up to 15 days |
| Type of adverse reactions on glibenclamide | evaluation of the type of adverse reactions identified during the study | At 36 week of amenorrhea corrected age |
| Number of adverse reactions on glibenclamide | evaluation of number of adverse reactions identified during the study | At 36 week of amenorrhea corrected age |
| Number of participants with co-morbidity | Neonatal morbidity assessed at 36 WA corrected age: intraventricular haemorrhage, periventricular leukomalacia, retinopathy of premature newborns, haemodynamic disorders, ulcerative necrotising enterocolitis | At 36 week of amenorrhea corrected age |
| Mortality | Mortality will be assessed | At 36 week of amenorrhea corrected age |
| Dose adjustment | Number of dose adjustments, to evaluate the easy of use | At the end of treatment assessed up to 15 days |
| ease of use by caregivers | Assessment scores by visual-analogue scale for ease of use by caregivers; 0 as the lowest score, 10 as the highest score | At day one of treatment |
| ease of use by caregivers | Assessment scores by visual-analogue scale for ease of use by caregivers; 0 as the lowest score, 10 as the highest score | At day two of treatment |
| ease of use by caregivers | Assessment scores by visual-analogue scale for ease of use by caregivers; 0 as the lowest score, 10 as the highest score | At day three of treatment |
| Plasma concentrations of glibenclamide | Evaluated by the pharmacokinetics study | At 3 hours after the first administration |
| Plasma concentrations of glibenclamide | Evaluated by the pharmacokinetics study | At 6 hours after the first administration |
| Plasma concentrations of glibenclamide | Evaluated by the pharmacokinetics study | At 10 hours after the first administration |
| Plasma concentrations of glibenclamide | Evaluated by the pharmacokinetics study | At 24 hours after the first administration |
| Plasma concentrations of glibenclamide | Evaluated by the pharmacokinetics study | At 24 hours of blood glucose stabilization |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D013450 |
| Sulfones |
| D013457 | Sulfur Compounds |