Condition category
Nutritional, Metabolic, Endocrine
Date applied
28/09/2005
Date assigned
21/10/2005
Last edited
13/06/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Paolo Pozzilli

ORCID ID

Contact details

Universita' Campus Bio-Medico
Piano Facolta' di Medicina
via Emilio Longoni
83
Rome
00155
Italy

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 measures

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

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

Sponsor information

Organisation

Andromeda Biotech Ltd (Israel)

Sponsor details

PO Box 4145
Ness Ziona
74140
Israel

Sponsor type

Industry

Website

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

Results - basic reporting

See https://clinicaltrials.gov/ct2/show/results/NCT00615264

Publication summary

2014 results in: https://www.ncbi.nlm.nih.gov/pubmed/24757230
2014 results in: https://www.ncbi.nlm.nih.gov/pubmed/24408401

Publication citations

Additional files

Editorial Notes

13/06/2016: Added publication references and link to results - basic reporting. 22/01/2008: the following changes were made to the trial record: 1. The overall trial end date was changed from 30/07/2009 to 31/08/2010. 2. The sponsor and funder of this trial were updated. The previous sponsor and funder of this trial was DeveloGen AG (Germany).