Efficacy and Safety Study of Sulfonylureas in Neonatal Diabetes Mellitus
GLIDKIR6-2
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.
1 other identifier
interventional
19
1 country
1
Brief Summary
The aim of our trial is to try to switch patients with permanent neonatal diabetes mellitus due to a Kir6.2 or SUR1 activating mutation from subcutaneous insulin to oral glibenclamide therapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2 diabetes-mellitus
Started Jul 2006
Longer than P75 for phase_2 diabetes-mellitus
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2006
CompletedFirst Submitted
Initial submission to the registry
January 24, 2008
CompletedFirst Posted
Study publicly available on registry
February 7, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedNovember 20, 2025
September 1, 2025
4.1 years
January 24, 2008
November 17, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
assess continuously the capillary glycaemia for three consecutive days and evaluate the insulin secretion under insulin and sulfonylureas
permanent
Secondary Outcomes (2)
Rate the neurological and developmental status of the patients to seek for a potential improvement under glibenclamide therapy
every year
To assess the kinetics of glibenclamide in children
at the end of study
Study Arms (1)
1
EXPERIMENTALGlibenclamide
Interventions
Switching the patients from subcutaneous insulin to oral glibenclamide therapy
Eligibility Criteria
You may qualify if:
- coding sequence of KCNJ11 or ABCC8 in patients having a permanent neonatal diabetes mellitus
- written informed consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Necker Hospital - Endocrinology Gynecology Pediatric unit
Paris, 75015, France
Related Publications (1)
Beltrand J, Elie C, Busiah K, Fournier E, Boddaert N, Bahi-Buisson N, Vera M, Bui-Quoc E, Ingster-Moati I, Berdugo M, Simon A, Gozalo C, Djerada Z, Flechtner I, Treluyer JM, Scharfmann R, Cave H, Vaivre-Douret L, Polak M; GlidKir Study Group. Sulfonylurea Therapy Benefits Neurological and Psychomotor Functions in Patients With Neonatal Diabetes Owing to Potassium Channel Mutations. Diabetes Care. 2015 Nov;38(11):2033-41. doi: 10.2337/dc15-0837. Epub 2015 Oct 5.
PMID: 26438614RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michel Polak, MD, PhD
Necker Hospital AP-HP
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 24, 2008
First Posted
February 7, 2008
Study Start
July 1, 2006
Primary Completion
August 1, 2010
Study Completion
December 1, 2011
Last Updated
November 20, 2025
Record last verified: 2025-09