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ISRCTN
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ISRCTN55429664
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ClinicalTrials.gov identifier
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NCT00615264
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Public title
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A phase III, multinational, randomised, double-blind, placebo-controlled, parallel-group study to investigate the clinical efficacy and safety of Diapep277™ in newly diagnosed type one diabetes patients
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Scientific title
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Acronym
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DIA-AID
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Serial number at source
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901
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Study hypothesis
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To test the hypothesis that pancreatic beta-cell function with DiaPep277™ is superior to that with placebo after 24 months.
Please note that as of 22nd January 2008, this record has been updated. The anticipated end date of this trial has been extended to 31/08/2010 (as below). The previous end date of this trial was 30/07/2009. Please also note that the sponsor and funder of this trial has also been updated. The previous sponsor and funder of this trial was DeveloGen AG (Germany).
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Lay summary
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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Austria, Czech Republic, Finland, France, Germany, Greece, Israel, Italy, South Africa, Spain, United Kingdom
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Disease/condition/study domain
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Type one Diabetes
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Participants - inclusion criteria
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At screening:
1. The patient has a diagnosis of type one diabetes mellitus according to the American Diabetes Association (ADA)/World Health Organisation (WHO) for up to 3 months (changed from 6 months on 05/03/07)
2. Evidence of residual beta-cell function demonstrated by basal fasting C-peptide concentrations more than or equal to 0.22 nmol/l
3. Presence of one or more of the following criteria:
a. at least one diabetes-related autoantibody: IA-2, insulin or glutamic acid decarboxylase (GAD) at screening
and/or
b. age at diagnosis less than 20 years and ketonuria at diagnosis
4. The patient is on insulin treatment for diabetes since diagnosis
5. The patient is male or female, aged 16 to 45 years, inclusive
6. If a female of child-bearing potential, the patient is not pregnant or lactating, and will use oral hormonal contraception or other equally effective contraceptive methods throughout the study. The partners of male patients, who are of child-bearing potential, should also use adequate contraception in order to avoid pregnancies
Inclusion criteria removed on 05/03/07: the patient has HbA1c of less than or equal to 9% within seven days prior to baseline visit
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Participants - exclusion criteria
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1. The patient is treated with inhaled insulin (changed from 'has an insulin pump in situ or is treated with inhaled insulin' on 05/03/07)
2. The patient has clinical evidence of any diabetes-related complication that in the opinion of the Investigator would interfere with the patient's participation in and/or completion of the study
3. Patient has history of endogenous allergic reactivity
4. The patient has a known immune deficiency from any disease, or a condition associated with an immune deficiency
5. The patient is receiving immunosuppressive or immunomodulating agents or cytotoxic therapy, or any medication that, in the opinion of the Investigator, might interfere with the study
6. Patients with severe renal failure at the screening visit (as defined by glomerular filtration rate less than 30 ml/min/1.73 m^2 by Cockroft and Gault calculation), hyperlipidemia is allowed
7. The patient has liver disease such as cirrhosis or chronic active hepatitis
Exclusion criteria removed on 05/03/07: severe ketonuria (+++ on urine stix testing; ++ on repeated urine stix testing)
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Anticipated start date
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01/10/2005
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Anticipated end date
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31/08/2010
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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400
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Interventions
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1 mg DiaPep277™ or placebo will be administered subcutaneously at baseline (zero), one, three, six, nine, 12, 15, 18 and 21 months visits for a total of nine administrations.
Both treatment groups will be balanced for HbA1c values (HbA1c inferior to 7.0% and HbA1c superior or equal to 7.0%) and basal fasting C-peptide concentrations (C-peptide < 0.40 nmol/L and C-peptide ≥ 0.40 nmol/L). [Changed on 05/03/07 from ' Both treatment groups will be balanced for HbA1c values (stratum A: patients with HbA1c less than 7.0%, stratum B: patients with HbA1c equal to or more than 7.0%).'].
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Primary outcome measure(s)
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Investigate the effect of DiaPep277™ versus placebo in patients with Type one Diabetes Mellitus on pancreatic beta-cell function as measured by stimulated C-peptide secretion after 24 month
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Secondary outcome measure(s)
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1. Assess the effect of DiaPep277™ on insulin dose requirement after 24 months
2. Assess the effect of DiaPep277™ versus placebo on metabolic control as measured by % HbA1c after 24 months and by glucose profile during the study
3. Assess the safety and tolerability of DiaPep277™ during the study
4. Assess the effects of DiaPep277™ on the occurrence of hypo- and hyper-glycemic events during the study
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Sources of funding
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Andromeda Biotech Ltd (Israel)
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Trial website
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Publications
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Contact name
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Prof
Paolo
Pozzilli
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Address
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Universita' Campus Bio-Medico
Piano Facolta' di Medicina
via Emilio Longoni, 83
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City/town
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Rome
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Zip/Postcode
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00155
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Country
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Italy
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Sponsor
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Andromeda Biotech Ltd (Israel)
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Address
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PO Box 4145
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City/town
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Ness Ziona
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Zip/Postcode
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74140
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Country
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Israel
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Date applied
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28/09/2005
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Last edited
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15/10/2008
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Date ISRCTN assigned
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21/10/2005
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