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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00610038 |
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Date of registration:
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24/01/2008 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Efficacy and Safety Study of Sulfonylureas in Neonatal Diabetes Mellitus
GLIDKIR6-2 |
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Scientific title:
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Sulfonylureas in Neonatal Diabetes Mellitus With Mutations of 2 Type of Subunits Kir6.2 and SUR1 of the Pancreatic Beta-cell ATP-sensitive K+ Channel. |
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Date of first enrolment:
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July 2006 |
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Target sample size:
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19 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00610038 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 2
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Countries of recruitment
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France
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Contacts
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Name:
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Michel Polak, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Necker Hospital AP-HP |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- coding sequence of KCNJ11 or ABCC8 in patients having a permanent neonatal diabetes
mellitus
- written informed consent
Exclusion Criteria:
- hypersensibility of sulfonylureas
- severe renal failure (clearance of creatinemia < 30 ml/min)
- severe hepatic failure (Prothrombin rate < 70 %)
- Porphyria
- imidazol treatments
- pregnancy
- no social security affiliation
Age minimum:
N/A
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Diabetes Mellitus
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Intervention(s)
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Drug: glibenclamide
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Primary Outcome(s)
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assess continuously the capillary glycaemia for three consecutive days and evaluate the insulin secretion under insulin and sulfonylureas
[Time Frame: permanent]
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Secondary Outcome(s)
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Rate the neurological and developmental status of the patients to seek for a potential improvement under glibenclamide therapy
[Time Frame: every year]
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To assess the kinetics of glibenclamide in children
[Time Frame: at the end of study]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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