Type 1 DiabetesPhase 3DIA-AIDNCT00615264
Efficacy Study of DiaPep277 in Newly Diagnosed Type 1 Diabetes Patients
A Phase 3 study testing DiaPep277 in people with Type 1 Diabetes, run by Andromeda Biotech Ltd. at 34 sites in 11 countries.
Trial summary
The purpose of this study is to determine if DiaPep277 can effectively protect the internal production of insulin in patients newly diagnosed with type 1 diabetes, by stopping the immune destruction of insulin-producing beta-cells in the pancreas. Read more about this study
- Who is it for?
- Ages 16 to 45 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- DiaPep277
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 457 participants
- Where
- 34 sitesin 11 countries
- Study dates
- Sep 2005to Jan 2012
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 16 to 45 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- A diagnosis of type 1 diabetes for up to 3 months at screening
- Insulin dependency
- Fasting C-peptide levels >= 0.22 nmol/L
- Presence of at least 1 of the diabetes-related autoantibodies (IA-2A, GAD or IA)
Who cannot join
- Pregnancy or intent to conceive in the next 2 years
- Significant diseases that could affect response to treatment, such as tumors, psychiatric disorders, substance abuse, severe allergies or diabetes-related complications.
- Patient has immune deficiency or receives immuno-suppressive or cytotoxic drugs.
Trial locations and contacts
34 sites in 11 countries.
34 sites in 11 countries
Italy5 sites
Universita' degli Studi di Bari
Bari, 70124
Ex Istituto di clinica medica
Palermo, 90127
University Campus Bio-Medico
Rome, 00155
Università "La Sapienza"
Rome, 00161
Istituto Clinico Humanitas
Rozzano, 20089
South Africa5 sites
Helderberg Clinical Trials Unit
Cape Town, 7129
New Groote Schuur Hospital
Cape Town, 7925
102 Parklands Medical Centre
Durban, 4091
Donald Gordon Medical Center
Johannesburg, 2193
Centre for Diabetes and Endocrinology
Johannesburg, 2198
France4 sites
CHU de Grenoble
Grenoble, 38043
Hopital Edouard Herriot
Lyon, 69003
Hopital La Timone
Marseille, 13005
CHU de Nîmes/ Hôpital Caremeau
Nîmes, 30029
Spain4 sites
Hospital de la Santa Creu
Barcelona, 08041
Hospital Universitari Arnau de Vilanova
Lleida, 5198
Hospital de Sabadell
Sabadell
Hospital Nuestra Señora de La Candelaria
Santa Cruz de Tenerife, 38010
Czechia3 sites
Faculty Hospital
Olomouc, 775 20
Faculty hospital Motol.
Prague, 150 06
IKEM/Diabetes Centre
Prague, 4 140 21
Finland3 sites
Pohjois-Karjala projektin tutkimussäätiö
Joensuu, 80100
Tutkimusyksikkö Oulu
Oulu, 90220
Diabetestutkimus
Vantaa, 01300
Germany3 sites
Universitätsklinikum
Giessen, 35392
Diabetes Centre for Children and Adolescents
Hanover, 30173
Institut für Diabetesforschung an der Klinik und Hochschulambulanz für Kinder- und Jugendmedizin
Munich, 80804
Israel3 sites
Wolfson Medical Centre
Holon, 58100
Hadassah University Hospital
Jerusalem, 91120
Schneider Children's Medical Centre
Petah Tikva, 49202
United Kingdom2 sites
St. Bartholomew's Hospital
London, EC1A 7BE
Royal Shrewsbury Hospital
Shrewsbury, SY3 8XQ
About this study
Official title: A Phase 3, Multinational, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study To Investigate The Clinical Efficacy And Safety of DiaPep277® in Newly Diagnosed Type 1 Diabetes Patients
The purpose of this study is to determine if DiaPep277 can effectively protect the internal production of insulin in patients newly diagnosed with type 1 diabetes, by stopping the immune destruction of insulin-producing beta-cells in the pancreas. DiaPep277 acts on the immune system and is expected to prevent further destruction of the beta-cells by stimulating regulatory responses, without causing immunological suppression.
- Conditions
- Type 1 Diabetes
- Being tested
- DiaPep277, Placebo
- 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.
DiaPep277Drug
1.0mg dose, administered as subcutaneous injection, on 0, 1, 3, 6, 9, 12, 15, 18 and 21 months
PlaceboDrug
Mannitol (excipient) 40 mg, administered as subcutaneous injection on 1, 3, 6, 9, 12, 15, 18 and 21 months.
| Study group | Role | What they receive |
|---|---|---|
| DiaPep277 | Experimental | DiaPep277 1.0 mg + 40 mg Mannitol in 0.5 mL lipid emulsion. Receives: Drug: DiaPep277 |
| Placebo | Placebo comparator | Mannitol 40 mg in 0.5 mL lipid emulsion. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Glucagon-stimulated C-peptide AUC at 24 Months
Beta-cell function, measured as change in stimulated C-peptide secretion measured 0, 2, 6, 10 and 20 minutes post administration [area under the curve (AUC), 0-20 minutes] at Baseline and 24 months, during a glucagon stimulation test (GST). The change in AUC was calculated per patient by subtracting the baseline AUC from the 24 month AUC.
Measured: Baseline and 24 months
Secondary outcomes (1)
Change From Baseline in Mixed-meal Stimulated C-peptide AUC at 24 Months
Beta cell function, measured as stimulated C-peptide secretion from 0 to 120 min post administration AUC, at baseline and 24 month measurements in a mixed-meal tolerance test (MMTT). The change in AUC was calculated per patient by subtracting the baseline AUC from the 24 month AUC.
Measured: Baseline and 24 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2008 (estimated)
- Study startSep 2005
- Primary completionSep 2011
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 457 participants (actual)
Sponsor and investigators
- Lead sponsor
- Andromeda Biotech Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Itamar Raz, MD, Principal investigator, Hadassah Medical Center, JerusalemPaolo Pozzilli, MD, Principal investigator, Universita Campus Bio-Medico, RomeFrancois Bonici, MD, Principal investigator, New Groote Schuur Hospital, Cape TownThomas Linn, MD, Principal investigator, Universitätsklinikum, Giessen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00615264
- Sponsor's protocol ID
- 901
- Other IDs
- ISRCTN55429664
- Acronym
- DIA-AID
- Status last verified
- May 2016
- First submitted
- 4 Feb 2008
- Last updated
- 6 Jun 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Raz I, Ziegler AG, Linn T, Schernthaner G, Bonnici F, Distiller LA, Giordano C, Giorgino F, de Vries L, Mauricio D, Prochazka V, Wainstein J, Elias D, Avron A, Tamir M, Eren R, Peled D, Dagan S, Cohen IR, Pozzilli P; DIA-AID 1 Writing Group. Treatment of recent-onset type 1 diabetic patients with DiaPep277: results of a double-blind, placebo-controlled, randomized phase 3 trial. Diabetes Care. 2014;37(5):1392-400. doi: 10.2337/dc13-1391.
PubMed 24757230Pozzilli P, Raz I, Peled D, Elias D, Avron A, Tamir M, Eren R, Dagan S, Cohen IR. Evaluation of long-term treatment effect in a type 1 diabetes intervention trial: differences after stimulation with glucagon or a mixed meal. Diabetes Care. 2014;37(5):1384-91. doi: 10.2337/dc13-1392. Epub 2014 Jan 9.
PubMed 24408401
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Multinational, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study To Investigate The Clinical Efficacy And Safety of DiaPep277® in Newly Diagnosed Type 1 Diabetes Patients
- ClinicalTrials.gov ID
- NCT00615264
- Acronym / sponsor ID
- DIA-AID / 901
- Conditions
- Type 1 Diabetes
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 457 participants (actual)
- Lead sponsor
- Andromeda Biotech Ltd.Industry (pharma, biotech, devices)
- Study start
- Sep 2005
- Primary completion
- Sep 2011 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 14 Feb 2008 (estimated)
- Results
- Posted 6 Jun 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine if DiaPep277 can effectively protect the internal production of insulin in patients newly diagnosed with type 1 diabetes, by stopping the immune destruction of insulin-producing beta-cells in the pancreas. DiaPep277 acts on the immune system and is expected to prevent further destruction of the beta-cells by stimulating regulatory responses, without causing immunological suppression.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DiaPep277 | Experimental | Drug: DiaPep277DiaPep277 1.0 mg + 40 mg Mannitol in 0.5 mL lipid emulsion. |
| Placebo | Placebo comparator | Drug: PlaceboMannitol 40 mg in 0.5 mL lipid emulsion. |
Who may qualify
- Ages
- 16 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- A diagnosis of type 1 diabetes for up to 3 months at screening
- Insulin dependency
- Fasting C-peptide levels >= 0.22 nmol/L
- Presence of at least 1 of the diabetes-related autoantibodies (IA-2A, GAD or IA)
Key exclusion criteria (3 listed)
- Pregnancy or intent to conceive in the next 2 years
- Significant diseases that could affect response to treatment, such as tumors, psychiatric disorders, substance abuse, severe allergies or diabetes-related complications.
- Patient has immune deficiency or receives immuno-suppressive or cytotoxic drugs.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DiaPep2771.0mg dose, administered as subcutaneous injection, on 0, 1, 3, 6, 9, 12, 15, 18 and 21 months | Drug | DiaPep277 |
| PlaceboMannitol (excipient) 40 mg, administered as subcutaneous injection on 1, 3, 6, 9, 12, 15, 18 and 21 months. | Drug | Placebo |
Primary outcome
Change From Baseline in Glucagon-stimulated C-peptide AUC at 24 Months
Time frame: Baseline and 24 months
Beta-cell function, measured as change in stimulated C-peptide secretion measured 0, 2, 6, 10 and 20 minutes post administration [area under the curve (AUC), 0-20 minutes] at Baseline and 24 months, during a glucagon stimulation test (GST). The change in AUC was calculated per patient by subtracting the baseline AUC from the 24 month AUC.
1 secondary outcome
Change From Baseline in Mixed-meal Stimulated C-peptide AUC at 24 Months
Time frame: Baseline and 24 Months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 24757230Raz I, Ziegler AG, Linn T, Schernthaner G, Bonnici F, Distiller LA, Giordano C, Giorgino F, de Vries L, Mauricio D, Prochazka V, Wainstein J, Elias D, Avron A, Tamir M, Eren R, Peled D, Dagan S, Cohen IR, Pozzilli P; DIA-AID 1 Writing Group. Treatment of recent-onset type 1 diabetic patients with DiaPep277: results of a double-blind, placebo-controlled, randomized phase 3 trial. Diabetes Care. 2014;37(5):1392-400. doi: 10.2337/dc13-1391.
- Derived from this study: PubMed 24408401Pozzilli P, Raz I, Peled D, Elias D, Avron A, Tamir M, Eren R, Dagan S, Cohen IR. Evaluation of long-term treatment effect in a type 1 diabetes intervention trial: differences after stimulation with glucagon or a mixed meal. Diabetes Care. 2014;37(5):1384-91. doi: 10.2337/dc13-1392. Epub 2014 Jan 9.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Itamar Raz, MD principal investigator
Hadassah Medical Center, Jerusalem
Paolo Pozzilli, MD principal investigator
Universita Campus Bio-Medico, Rome
Francois Bonici, MD principal investigator
New Groote Schuur Hospital, Cape Town
34 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing DiaPep277 in people with Type 1 Diabetes, run by Andromeda Biotech Ltd. at 34 sites in 11 countries.
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 4 inclusion and 3 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 6 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 34 sites in Italy, South Africa, France, Spain, Czechia and 6 more countries. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Jun 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change From Baseline in Glucagon-stimulated C-peptide AUC at 24 Months (time frame: Baseline and 24 months). 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 NCT00615264, which also lists 2 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 6 Jun 2016.