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Diabetes, Type IPhase 2NCT00654121

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

A Phase 2 study testing Actrapid HM in people with Diabetes, Type I, run by Universitair Ziekenhuis Brussel at 3 sites in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 5 to 39 yearsHealthy volunteers can take part
Conditions the study is for
Diabetes, Type I
What is being tested?
Actrapid HM
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
112 participants
Where
3 sitesBelgium
Study dates
Feb 2000to Nov 2007
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 5 to 39 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • 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
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  • 2 hour plasma glucose < 140 mg/dL
  • Impaired Fasting Glucose (IFG):
  • fasting plasma glucose 110-125 mg/dL and
  • 2 hour plasma glucose < 140 mg/dL
  • Impaired Glucose Tolerance (IGT):
  • fasting plasma glucose <110 mg/dL and
  • 2 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)
  • cooperative and reliable subject (age ≥ 14 yrs) / parents (age < 14 yrs) giving informed consent by signature; the patient/parents should be informed in sufficient detail on the content and procedure of the protocol, indicating potential risks of insulin therapy; early intervention with metabolically active insulin treatment should be identified as a clinical trial. Both parents should sign and agree with the protocol procedure.

Who cannot join

  • diabetes by 1997 ADA criteria (33):
  • fasting plasma glucose ≥ 126 mg/dL, or
  • 2 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
Show all 12Show fewer
  • 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

Trial locations and contacts

3 sites in 1 country.

Belgium3 sites

  • Universitair Ziekenhuis Antwerpen

    Antwerp

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

    Brussels, 1090

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

    Leuven, 3000

Other trials in Belgium

About this study

Official title: Prevention of Clinical Onset of Type 1 Diabetes by Daily Administration of Metabolically Active Insulin in High Risk First Degree Relatives.

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).

Read the detailed description

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.

Being tested
Actrapid HM
Keywords
prevention
Medical subject headings
Diabetes Mellitus, Type 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Actrapid HMDrug

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

Study groups in NCT00654121
Study groupRoleWhat they receive
1Active comparator56 subjects will receive metabolically active insulin by subcutaneous injections for 36 months (twice daily)
Receives: Drug: Actrapid HM
2No interventionNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Fasting glycemia;

    Measured: 2004

  2. fasting and stimulated plasma C-peptide and proinsulin values;

    Measured: 2004

  3. islet cell autoantibodies;

    Measured: 2004

  4. body weight gain.

    Measured: 2004

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Apr 2008 (estimated)
  2. Study startFeb 2000
  3. Primary completionApr 2004
  4. Study completionNov 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
112 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00654121
Sponsor's protocol ID
EVDM IT 001
Status last verified
Apr 2008
First submitted
2 Apr 2008
Last updated
7 Apr 2008
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 15756536

  • 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.

    PubMed 14534938

  • 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.

    PubMed 12488955

  • 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.

    PubMed 19898832

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Actrapid HM in people with Diabetes, Type I, run by Universitair Ziekenhuis Brussel at 3 sites in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Apr 2008. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Fasting glycemia; (time frame: 2004). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00654121, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2008.

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