Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT00615264
Protocol/serial number
901
Study information
Scientific title
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
Acronym
DIA-AID
Study hypothesis
To test the hypothesis that pancreatic beta-cell function with DiaPep277™ is superior to that with placebo after 24 months.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
Condition
Type one diabetes
Intervention
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%).'].
Intervention type
Drug
Phase
Phase III
Drug names
Diapep277™
Primary outcome measure
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 months
Secondary outcome measures
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
Overall trial start date
01/10/2005
Overall trial end date
31/08/2010
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
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 05/03/2007)
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:
3.1. At least one diabetes-related autoantibody: IA-2, insulin or glutamic acid decarboxylase (GAD) at screening
and/or
3.2. 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 05/03/2007: the patient has HbA1c of less than or equal to 9% within seven days prior to baseline visit
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
400
Participant exclusion criteria
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 05/03/2007: severe ketonuria (+++ on urine stix testing; ++ on repeated urine stix testing)
Recruitment start date
01/10/2005
Recruitment end date
31/08/2010
Locations
Countries of recruitment
Austria, Czech Republic, Finland, France, Germany, Greece, Israel, Italy, South Africa, Spain, United Kingdom
Trial participating centre
Universita' Campus Bio-Medico
Rome
00155
Italy
Funders
Funder type
Industry
Funder name
Andromeda Biotech Ltd (Israel)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
See https://clinicaltrials.gov/ct2/show/results/NCT00615264
Publication list
2014 results in: https://www.ncbi.nlm.nih.gov/pubmed/24757230
2014 results in: https://www.ncbi.nlm.nih.gov/pubmed/24408401