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Sponsors and Collaborators: |
AZ-VUB Novo Nordisk |
Information provided by: | AZ-VUB |
ClinicalTrials.gov Identifier: | NCT00654121 |
Prophylactic administration of metabolically active insulin can prevent or delay clinical onset of diabetes in a high risk group of nondiabetic siblings as defined by positivity for autoantibodies against IA-2 (IA-2-A).
Condition | Intervention | Phase |
Diabetes, Type I |
Drug: Actrapid HM |
Phase II |
MedlinePlus related topics: | Diabetes Diabetes Type 1 |
ChemIDplus related topics: | Insulin |
Study Type: | Interventional |
Study Design: | Prevention, Open Label, Parallel Assignment, Efficacy Study |
Official Title: | Prevention of Clinical Onset of Type 1 Diabetes by Daily Administration of Metabolically Active Insulin in High Risk First Degree Relatives. |
Enrollment: | 112 |
Study Start Date: | February 2000 |
Study Completion Date: | November 2007 |
Primary Completion Date: | April 2004 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
1: Active Comparator
56 subjects will receive metabolically active insulin by subcutaneous injections for 36 months (twice daily)
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Drug: Actrapid HM
56 subjects will receive metabolically active insulin by subcutaneous injections for 36 months (twice daily)
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2: No Intervention |
Hypotheses:
Primary: Prophylactic administration of metabolically active insulin can prevent or delay clinical onset of diabetes in a high risk group of nondiabetic siblings as defined by positivity for autoantibodies against IA-2 (IA-2-A).
Secondary: 1) Untreated siblings with positivity for IA-2-A develop clinical diabetes significantly faster than untreated offspring with the same marker positivity. 2) Plasma proinsulin levels increase disproportionately before clinical onset of Type 1 diabetes both in siblings and offspring. 3) Prophylactic administration of metabolically active insulin reduces the plasma proinsulin/C-peptide ratio in non-diabetic antibody positive siblings and offspring. 4) Prophylactic administration of metabolically active insulin reduces the presence and/or levels of diabetes-associated autoantibodies directed against islet cell components.
Endpoints: Fasting glycemia; fasting and stimulated plasma C-peptide and proinsulin values; islet cell autoantibodies; incidence of hypoglycemia; body weight gain.
Ages Eligible for Study: | 5 Years to 39 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
fasting plasma glucose <126 mg/dL AND an OGTT that is non-diabetic by 1997 ADA criteria (33):
Normal glycemia:
Impaired Fasting Glucose (IFG):
Impaired Glucose Tolerance (IGT):
Exclusion Criteria:
diabetes by 1997 ADA criteria (33):
Belgium | |||||
Academisch Ziekenhuis and Diabetes Research Center - Brussels Free University-VUB | |||||
Brussels, Belgium, 1090 | |||||
Department of Endocrinology and Nephrology, UZ Gasthuisberg, Katholieke Universiteit Leuven -KUL | |||||
Leuven, Belgium, 3000 | |||||
Universitair Ziekenhuis Antwerpen | |||||
Antwerpen, Belgium |
AZ-VUB |
Novo Nordisk |
Principal Investigator: | Frans Gorus, MD,PhD | Universitair Ziekenhuis Brussel |
Principal Investigator: | Evy Vandemeulebroucke, MD | Universitair Ziekenhuis Brussel |
Responsible Party: | Free University Brussels ( Prof. F Gorus ) |
Study ID Numbers: | EVDM IT 001 |
First Received: | April 2, 2008 |
Last Updated: | April 4, 2008 |
ClinicalTrials.gov Identifier: | NCT00654121 |
Health Authority: | Belgium: Federal Agency for Medicinal Products and Health Products |
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