Prevention of Clinical Onset of Type 1 Diabetes in High Risk First Degree Relatives

NCT00654121 | Completed Phase 2

• 1 other identifier: EVDM IT 001
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 3

Brief Summary

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).

Conditions

Diabetes, Type I

Keywords

prevention

Outcome Measures

Primary Outcomes (4)

• Fasting glycemia;

  2004

• fasting and stimulated plasma C-peptide and proinsulin values;

  2004

• islet cell autoantibodies;

  2004

• body weight gain.

  2004

Study Arms (2)

1

ACTIVE COMPARATOR

56 subjects will receive metabolically active insulin by subcutaneous injections for 36 months (twice daily)

Drug: Actrapid HM

2

NO INTERVENTION

Interventions

Actrapid HM DRUG

56 subjects will receive metabolically active insulin by subcutaneous injections for 36 months (twice daily)

1

Eligibility Criteria

• Age: 5 Years - 39 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Sibling/offspring of a Type 1 diabetic patient
• in good general condition
• age 5-39 years
• fasting plasma glucose \<126 mg/dL AND an OGTT that is non-diabetic by 1997 ADA criteria (33):
• Normal glycemia:
• fasting plasma glucose \< 110 mg/dL and
• hour plasma glucose \< 140 mg/dL
• Impaired Fasting Glucose (IFG):
• fasting plasma glucose 110-125 mg/dL and
• hour plasma glucose \< 140 mg/dL
• Impaired Glucose Tolerance (IGT):
• fasting plasma glucose \<110 mg/dL and
• hour plasma glucose 140-199 mg/dL
• at least positive for IA-2-A
• absence of a protective DQ genotype: A4-B2/X or X/Y or X/X where X = A2-B3.3, A1-B1.9, A1-B1.2, A4-B3.1, A2-B2 or A4.23-B3.1 Y = A1-B1.1, A1-B2, A1-B1.AZH, A3-B2, A3-B3.1, A3-B3.3, A3-B4, A4-B4, A4.23-B4, A4-B3.2, A3-B1.1, A4-B3.3, A4-B1.1 or A4.23-B2 (32)

You may not qualify if:

• diabetes by 1997 ADA criteria (33):
• fasting plasma glucose ≥ 126 mg/dL, or
• hour plasma glucose ≥ 200 mg/dL
• donation of blood during the study or within one month prior to screening
• pregnancy or lactation in women
• use of inadequate anticonception by female patients of childbearing potential
• use of illicit drugs or overconsumption of alcohol (\> 3 beers/day) or history of drug or alcohol abuse
• being legally incapacitated, having significant emotional problems at the time of the study, or having a history of psychiatric disorders
• having received antidepressant medications during the last 6 months
• treatment with immune modulating or diabetogenic medication (such as corticosteroids)
• presently participating in another clinical study or having done so during the last 12 months
• history of any illness that, in the opinion of the investigator, might confound the results of the study or pose additional risks to the patient

Sponsors & Collaborators

• AZ-VUB: lead
• Novo Nordisk A/S: collaborator

Study Sites (3)

Universitair Ziekenhuis Antwerpen

Antwerp, Belgium

Location

Academisch Ziekenhuis and Diabetes Research Center - Brussels Free University-VUB

Brussels, 1090, Belgium

Location

Department of Endocrinology and Nephrology, UZ Gasthuisberg, Katholieke Universiteit Leuven -KUL

Leuven, 3000, Belgium

Location

Related Publications (4)

• Decochez K, Truyen I, van der Auwera B, Weets I, Vandemeulebroucke E, de Leeuw IH, Keymeulen B, Mathieu C, Rottiers R, Pipeleers DG, Gorus FK; Belgian Diabetes Registry. Combined positivity for HLA DQ2/DQ8 and IA-2 antibodies defines population at high risk of developing type 1 diabetes. Diabetologia. 2005 Apr;48(4):687-94. doi: 10.1007/s00125-005-1702-x. Epub 2005 Mar 9.

  PMID: 15756536 BACKGROUND

• Gorus FK, Weets I, Decochez K, van der Auwera BJ. [Preventative biology of type 1 diabetes: implications for clinical preventative studies]. Verh K Acad Geneeskd Belg. 2003;65(4):203-29; discussion 229-31. Dutch.

  PMID: 14534938 BACKGROUND

• Decochez K, De Leeuw IH, Keymeulen B, Mathieu C, Rottiers R, Weets I, Vandemeulebroucke E, Truyen I, Kaufman L, Schuit FC, Pipeleers DG, Gorus FK; Belgian Diabetes Registry. IA-2 autoantibodies predict impending type I diabetes in siblings of patients. Diabetologia. 2002 Dec;45(12):1658-66. doi: 10.1007/s00125-002-0949-8. Epub 2002 Nov 12.

  PMID: 12488955 BACKGROUND

• Vandemeulebroucke E, Keymeulen B, Decochez K, Weets I, De Block C, Fery F, Van de Velde U, Vermeulen I, De Pauw P, Mathieu C, Pipeleers DG, Gorus FK; Belgian Diabetes Registry. Hyperglycaemic clamp test for diabetes risk assessment in IA-2-antibody-positive relatives of type 1 diabetic patients. Diabetologia. 2010 Jan;53(1):36-44. doi: 10.1007/s00125-009-1569-3. Epub 2009 Nov 7.

  PMID: 19898832 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Frans Gorus, MD,PhD

  Universitair Ziekenhuis Brussel

  PRINCIPAL INVESTIGATOR

• Evy Vandemeulebroucke, MD

  Universitair Ziekenhuis Brussel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 2, 2008
• First Posted: April 7, 2008
• Study Start: February 1, 2000
• Primary Completion: April 1, 2004
• Study Completion: November 1, 2007
• Last Updated: April 7, 2008

Record last verified: 2008-04

Locations

BE (3)