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
| ISRCTN | ISRCTN55429664 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN55429664 |
| ClinicalTrials.gov number | NCT00615264 |
| Secondary identifying numbers | 901 |
- Submission date
- 28/09/2005
- Registration date
- 21/10/2005
- Last edited
- 13/06/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Paolo Pozzilli
Scientific
Scientific
Universita' Campus Bio-Medico
Piano Facolta' di Medicina
via Emilio Longoni, 83
Rome
00155
Italy
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| 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 |
| Study acronym | DIA-AID |
| Study objectives | To test the hypothesis that pancreatic beta-cell function with DiaPep277™ is superior to that with placebo after 24 months. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Phase III |
| Drug / device / biological / vaccine name(s) | 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 study start date | 01/10/2005 |
| Completion date | 31/08/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 400 |
| Key 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 |
| Key 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) |
| Date of first enrolment | 01/10/2005 |
| Date of final enrolment | 31/08/2010 |
Locations
Countries of recruitment
- Austria
- Czech Republic
- Finland
- France
- Germany
- Greece
- Israel
- Italy
- South Africa
- Spain
- United Kingdom
Study participating centre
Universita' Campus Bio-Medico
Rome
00155
Italy
00155
Italy
Sponsor information
Andromeda Biotech Ltd (Israel)
Industry
Industry
PO Box 4145
Ness Ziona
74140
Israel
"ROR" |
https://ror.org/00kyj9h67 |
|---|
Funders
Funder type
Industry
Andromeda Biotech Ltd (Israel)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Basic results | No | No | |||
| Results article | results | 01/07/2014 | Yes | No | |
| Results article | results | 01/07/2014 | Yes | No |
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).
