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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-002775-17 | EudraCT Number |
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A corporate decision to suspend development of DiaPep277®
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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®.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DiaPep277® | Experimental | Administration of DiaPep277® to patients previously enrolled in the Phase 3 Study 1001 (NCT01103284) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Hypoglycemic Events | The number of hypoglycemic events recorded by each patient over the course of the study. | At Early Termination Visit, Up to 25 Months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Daily Insulin Dose, Per kg Body Weight, at Early Termination Visit | Baseline and Early Termination Visit, up to 25 months | |
| Glycemic Control (Change From Baseline in % HbA1c) | Baseline and Early Termination Visit, Up to 25 Months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Itamar Raz, MD | Hadassah Medical Center, Jerusalem | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Atlanta Diabetes associates | Atlanta | Georgia | 30318 | United States | ||
| Henry Ford Medical Centers - New Center One |
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Patients diagnosed with Type 1 diabetes mellitus up to six months before randomization to Study 1001 (NCT01103284), from medical sites in the EU, US, Russia, and Israel
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| ID | Title | Description |
|---|---|---|
| FG000 | Patients Treated With DiaPep (Originally Enrolled in Study1001 | All patients enrolled in the 1010 study (NCT01898286), whether previously treated with DiaPep277 or placebo in the 1001 study (NCT01103284). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Patients Treated With DiaPep (Originally Enrolled in Study1001 | All patients enrolled in the 1010 study (NCT01898286), whether previously treated with DiaPep277 or placebo in the 1001 study (NCT01103284). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Hypoglycemic Events | The number of hypoglycemic events recorded by each patient over the course of the study. | Patients with hypoglycemic event data at the time of their early termination visit. This population is smaller than the population numbers in the patient flow categories because not all patients were willing to provide information on hypoglycemic events at early termination. | Posted | Mean | Standard Deviation | hypoglycemic events | At Early Termination Visit, Up to 25 Months |
|
AE data were collected from the time of subject enrollment through each subject's early termination visit
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Patients Treated With DiaPep (Originally Enrolled in Study1001 | All patients enrolled in the 1010 study (NCT01898286), whether previously treated with DiaPep277 or placebo in the 1001 study (NCT01103284). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaphylaxic shock for glucagon | Immune system disorders | MedDRA (17.0) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
The objectives of this study were to evaluate the safety and tolerability of long term treatment with DiaPep277. The study was terminated by the Sponsor on 08Sep14; hence many of the protocol-specified objectives could not be adequately assessed
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jeanne Novak | CBR International | 7207461190 | jnovak@cbrintl.com |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Baseline and Early Termination Visit, Up to 25 Months |
| Detroit |
| Michigan |
| 48202 |
| United States |
| Mountain Diabetes and Endocrine Center | Asheville | North Carolina | 28803 | United States |
| years |
|
| Age, Customized | Median | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Units | Counts |
|---|
| Participants |
|
|
| Secondary | 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. | Only 9 patients had sufficient data for this analysis, as many patients declined to undergo the GST at the termination visit. | Posted | Mean | Standard Deviation | nmol*minute/L | Baseline and Early Termination Visit, Up to 25 Months |
|
|
|
| Other Pre-specified | Change From Baseline in Daily Insulin Dose, Per kg Body Weight, at Early Termination Visit | All patients with daily insulin dose data at baseline and their early termination visit. Only 11 patients could be included in this analysis, as not all patients provided insulin dose data at their early termination visit. | Posted | Mean | Standard Deviation | IU/kg | Baseline and Early Termination Visit, up to 25 months |
|
|
|
| Other Pre-specified | Glycemic Control (Change From Baseline in % HbA1c) | All patients with % HbA1c data at baseline and their early termination visit. Only 5 patients were available for this analysis, as not all patients agreed to complete HbA1c testing at the early termination visit. | Posted | Mean | Standard Deviation | % HbA1c | Baseline and Early Termination Visit, Up to 25 Months |
|
|
|
| 1 |
| 38 |
| 9 |
| 38 |
| Influenza | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
|
| Electrocardiogram QT prolonged | Investigations | MedDRA (17.0) | Non-systematic Assessment |
|
| Blood cholesterol increased | Investigations | MedDRA (17.0) | Non-systematic Assessment |
|
| Low density lipoprotein increased | Investigations | MedDRA (17.0) | Non-systematic Assessment |
|
| Urine albumin/creatinine ratio increased | Investigations | MedDRA (17.0) | Non-systematic Assessment |
|
| Injection site erythema | General disorders | MedDRA (17.0) | Non-systematic Assessment |
|
| Non-cardiac chest pain | General disorders | MedDRA (17.0) | Non-systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA (17.0) | Non-systematic Assessment |
|
| Social phobia | Psychiatric disorders | MedDRA (17.0) | Non-systematic Assessment |
|
| Pancytopenia | Blood and lymphatic system disorders | MedDRA (17.0) | Non-systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA (17.0) | Non-systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA (17.0) | Non-systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA (17.0) | Non-systematic Assessment |
|
Investigator shall submit any paper or presentation to the Sponsor for review and comments at least 60 days prior to submitting the same to a third party. Upon receiving any request from the Sponsor to delete any Confidential Information or request to delay in publication up to 90 days to allow the filing of any Sponsor application, the Investigator shall take the request action. Investigator shall not be restricted after 18 months from completion of their site's performance in the study.
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |