Type 1 DiabetesPhase 3DIA-AID 2NCT01898286
Open-Label Extension Study to Evaluate Long Term Safety and Treatment Effect of DiaPep277®
A Phase 3 study testing DiaPep277® in people with Type 1 Diabetes, run by Andromeda Biotech Ltd. at 3 sites in United States.
Trial summary
This is an extension study to evaluate the safety and tolerability of long-term treatment with DiaPep277® and to determine the long-term treatment effect of DiaPep277® on parameters of metabolic control and on preservation of beta-cell function in subjects who have long exposure to DiaPep277®. Read more about this study
- Who is it for?
- Ages 18 to 47 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?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 3 sitesUnited States
- Study dates
- Oct 2013to Dec 2014
- 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 18 to 47 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- patients with type 1 diabetes who participated in the 1001 study
- residual beta-cell function demonstrated by stimulated C-peptide ≥ 0.20 nmol/L.
Who cannot join
- The subject has any significant ongoing diseases or conditions that is likely to affect the subject's response to treatment
- The subject has a history of any kind of malignant tumor.
- The subject has clinical evidence of any diabetes-related complication
- Subject has history of endogenous allergic reactivity:
- The subject has a known immune deficiency
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Mountain Diabetes and Endocrine Center
Asheville, North Carolina, 28803
Atlanta Diabetes associates
Atlanta, Georgia, 30318
Henry Ford Medical Centers - New Center One
Detroit, Michigan, 48202
About this study
Official title: Open-Label Study to Evaluate Long Term Safety and Treatment Effect of DiaPep277® in Subjects Who Have Completed Study 1001 (NCT01103284)
This is an extension study to evaluate the safety and tolerability of long-term treatment with DiaPep277® and to determine the long-term treatment effect of DiaPep277® on parameters of metabolic control and on preservation of beta-cell function in subjects who have long exposure to DiaPep277®.
Read the detailed description
Treatment with DiaPep277® is expected to be long-term; stopping treatment may result in the eventual loss of the preserved beta-cell function. Indeed, extension of phase 2 studies has shown that patients who were initially treated with DiaPep277® and maintained their initial beta-cell function, required continuation of treatment, losing beta-cell function if switched to Placebo. These extension studies were too small for the outcome to be statistically significant, but they suggested that continuation of treatment is needed for long-term maintenance of efficacy.
Therefore, in this extension study, patients who complete the 1001 phase 3 study (NCT01103284) and maintain clinically significant beta-cell function are offered a 2-year continuation of active treatment, since they are likely to benefit from use of the medication. The participation in the extension study will be offered to all eligible subjects who complete the 1001 study, regardless of the treatment arm allocation in the initial study.
By achieving long-term preservation of beta-cell function, patients are expected to maintain good management of the disease, manifesting as better glycemic control and fewer hypoglycemic events.
- Conditions
- Type 1 Diabetes
- Being tested
- DiaPep277®
- Keywords
- C peptide, beta cell function, immune modulation of type 1 diabetes, immune intervention in type 1 diabetes
- 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.
DiaPep277®Drug
1 mg of DiaPep277® subcutaneously in the upper arm at 0, 3, 6, 9, 12, 15, 18, and 21 months, for a total of 8 administrations
| Study group | Role | What they receive |
|---|---|---|
| DiaPep277® | Experimental | Administration of DiaPep277® to patients previously enrolled in the Phase 3 Study 1001 (NCT01103284) Receives: Drug: DiaPep277® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hypoglycemic Events
The number of hypoglycemic events recorded by each patient over the course of the study.
Measured: At Early Termination Visit, Up to 25 Months
Secondary outcomes (1)
Change From Baseline in Glucagon-stimulated C-peptide AUC at Early Termination Visit
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 the early termination visit (up to 25 months), during a glucagon stimulation test (GST). Change was calculated for each patient by subtracting the baseline AUC value (defined as the last non-missing assessment prior to first dose in the 1010 study but after the end of study 1001) from the early termination visit AUC.
Measured: Baseline and Early Termination Visit, Up to 25 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2013 (estimated)
- Study startOct 2013
- Primary completionSep 2014
- Study completionDec 2014
Why it stopped: A corporate decision to suspend development of DiaPep277®
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.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 38 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, Jerusalem
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01898286
- Sponsor's protocol ID
- 1010
- Other IDs
- 2013-002775-17
- Acronym
- DIA-AID 2
- Status last verified
- Apr 2016
- First submitted
- 10 Jul 2013
- Last updated
- 26 May 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-Label Study to Evaluate Long Term Safety and Treatment Effect of DiaPep277® in Subjects Who Have Completed Study 1001 (NCT01103284)
- ClinicalTrials.gov ID
- NCT01898286
- Acronym / sponsor ID
- DIA-AID 2 / 1010
- Conditions
- Type 1 Diabetes
- Keywords
- C peptide, beta cell function, immune modulation of type 1 diabetes, immune intervention in type 1 diabetes
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: A corporate decision to suspend development of DiaPep277®
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Andromeda Biotech Ltd.Industry (pharma, biotech, devices)
- Study start
- Oct 2013
- Primary completion
- Sep 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 12 Jul 2013 (estimated)
- Results
- Posted 26 May 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an extension study to evaluate the safety and tolerability of long-term treatment with DiaPep277® and to determine the long-term treatment effect of DiaPep277® on parameters of metabolic control and on preservation of beta-cell function in subjects who have long exposure to DiaPep277®.
Detailed description
Treatment with DiaPep277® is expected to be long-term; stopping treatment may result in the eventual loss of the preserved beta-cell function. Indeed, extension of phase 2 studies has shown that patients who were initially treated with DiaPep277® and maintained their initial beta-cell function, required continuation of treatment, losing beta-cell function if switched to Placebo. These extension studies were too small for the outcome to be statistically significant, but they suggested that continuation of treatment is needed for long-term maintenance of efficacy.
Therefore, in this extension study, patients who complete the 1001 phase 3 study (NCT01103284) and maintain clinically significant beta-cell function are offered a 2-year continuation of active treatment, since they are likely to benefit from use of the medication. The participation in the extension study will be offered to all eligible subjects who complete the 1001 study, regardless of the treatment arm allocation in the initial study.
By achieving long-term preservation of beta-cell function, patients are expected to maintain good management of the disease, manifesting as better glycemic control and fewer hypoglycemic events.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DiaPep277® | Experimental | Drug: DiaPep277®Administration of DiaPep277® to patients previously enrolled in the Phase 3 Study 1001 (NCT01103284) |
Who may qualify
- Ages
- 18 to 47 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- patients with type 1 diabetes who participated in the 1001 study
- residual beta-cell function demonstrated by stimulated C-peptide ≥ 0.20 nmol/L.
Key exclusion criteria (5 listed)
- The subject has any significant ongoing diseases or conditions that is likely to affect the subject's response to treatment
- The subject has a history of any kind of malignant tumor.
- The subject has clinical evidence of any diabetes-related complication
- Subject has history of endogenous allergic reactivity:
- The subject has a known immune deficiency
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 |
|---|---|---|
| DiaPep277®1 mg of DiaPep277® subcutaneously in the upper arm at 0, 3, 6, 9, 12, 15, 18, and 21 months, for a total of 8 administrations | Drug | DiaPep277® |
Primary outcome
Hypoglycemic Events
Time frame: At Early Termination Visit, Up to 25 Months
The number of hypoglycemic events recorded by each patient over the course of the study.
1 secondary outcome
Change From Baseline in Glucagon-stimulated C-peptide AUC at Early Termination Visit
Time frame: Baseline and Early Termination Visit, Up to 25 Months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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
3 sites in 1 country: 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 3 sites in United States.
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 2 inclusion and 5 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: stopped early, as of the sponsor's last update on 26 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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. 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 26 May 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?
Hypoglycemic Events (time frame: At Early Termination Visit, Up to 25 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 May 2016.