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| ID | Type | Description | Link |
|---|---|---|---|
| ISRCTN55429664 |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DiaPep277 | Experimental | DiaPep277 1.0 mg + 40 mg Mannitol in 0.5 mL lipid emulsion. |
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| Placebo | Placebo Comparator | Mannitol 40 mg in 0.5 mL lipid emulsion. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DiaPep277 | Drug | 1.0mg dose, administered as subcutaneous injection, on 0, 1, 3, 6, 9, 12, 15, 18 and 21 months |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and 24 Months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Itamar Raz, MD | Hadassah Medical Center, Jerusalem | Principal Investigator |
| Paolo Pozzilli, MD | Universita Campus Bio-Medico, Rome | Principal Investigator |
| Francois Bonici, MD | New Groote Schuur Hospital, Cape Town | Principal Investigator |
| Thomas Linn, MD | Universitätsklinikum, Giessen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rudolfstiftung Hospital | Vienna | 1030 | Austria | |||
| Faculty Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24757230 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | DiaPep277 | DiaPep277 1.0 mg + 40 mg Mannitol in 0.5 mL lipid emulsion. DiaPep277: 1.0 mg dose, administered as subcutaneous injection, on 0, 1, 3, 6, 9, 12, 15, 18 and 21 months |
| FG001 | Placebo |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Placebo | Drug | Mannitol (excipient) 40 mg, administered as subcutaneous injection on 1, 3, 6, 9, 12, 15, 18 and 21 months. |
|
| Olomouc |
| 775 20 |
| Czechia |
| Faculty hospital Motol. | Prague | 150 06 | Czechia |
| IKEM/Diabetes Centre | Prague | 4 140 21 | Czechia |
| Pohjois-Karjala projektin tutkimussäätiö | Joensuu | 80100 | Finland |
| Tutkimusyksikkö Oulu | Oulu | 90220 | Finland |
| Diabetestutkimus | Vantaa | 01300 | Finland |
| CHU de Grenoble | Grenoble | 38043 | France |
| Hopital Edouard Herriot | Lyon | 69003 | France |
| Hopital La Timone | Marseille | 13005 | France |
| CHU de Nîmes/ Hôpital Caremeau | Nîmes | 30029 | France |
| Universitätsklinikum | Giessen | 35392 | Germany |
| Diabetes Centre for Children and Adolescents | Hanover | 30173 | Germany |
| Institut für Diabetesforschung an der Klinik und Hochschulambulanz für Kinder- und Jugendmedizin | Munich | 80804 | Germany |
| Laiko hospital | Athens | 11572 | Greece |
| Wolfson Medical Centre | Holon | 58100 | Israel |
| Hadassah University Hospital | Jerusalem | 91120 | Israel |
| Schneider Children's Medical Centre | Petah Tikva | 49202 | Israel |
| Universita' degli Studi di Bari | Bari | 70124 | Italy |
| Ex Istituto di clinica medica | Palermo | 90127 | Italy |
| University Campus Bio-Medico | Rome | 00155 | Italy |
| Università "La Sapienza" | Rome | 00161 | Italy |
| Istituto Clinico Humanitas | Rozzano | 20089 | Italy |
| Helderberg Clinical Trials Unit | Cape Town | 7129 | South Africa |
| New Groote Schuur Hospital | Cape Town | 7925 | South Africa |
| 102 Parklands Medical Centre | Durban | 4091 | South Africa |
| Donald Gordon Medical Center | Johannesburg | 2193 | South Africa |
| Centre for Diabetes and Endocrinology | Johannesburg | 2198 | South Africa |
| Hospital de la Santa Creu | Barcelona | 08041 | Spain |
| Hospital Universitari Arnau de Vilanova | Lleida | 5198 | Spain |
| Hospital de Sabadell | Sabadell | Spain |
| Hospital Nuestra Señora de La Candelaria | Santa Cruz de Tenerife | 38010 | Spain |
| St. Bartholomew's Hospital | London | EC1A 7BE | United Kingdom |
| Royal Shrewsbury Hospital | Shrewsbury | SY3 8XQ | United Kingdom |
| 24408401 | Derived | Pozzilli 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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Mannitol 40 mg in 0.5 mL lipid emulsion.
Placebo: Mannitol (excipient) 40 mg, administered as subcutaneous injection on 1, 3, 6, 9, 12, 15, 18 and 21 months.
| Received at Least One Dose (ITT) |
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| ITT Patients Who Met Inc/Excl (MITT) |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | DiaPep277 | DiaPep277 1.0 mg + 40 mg Mannitol in 0.5mL Lipid emulsion. DiaPep277: 1.0 mg dose, administered as subcutaneous injection, on 0, 1, 3, 6, 9, 12, 15, 18 and 21 months |
| BG001 | Placebo | Mannitol 40 mg in 0.5 mL Lipid emulsion. Placebo: Mannitol (excipient) 40 mg, administered as subcutaneous injection on 1, 3, 6, 9, 12, 15, 18 and 21 months. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Age, Customized | Median | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | participants |
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| 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 | 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. | Modified Intent to Treat (MITT) Population - all randomized patients who received at least one dose of study medication and who entered the study according to the definition of the target population, as defined by the inclusion and exclusion criteria in the study protocol | Posted | Mean | Standard Error | nmol*minute/L | Baseline and 24 months |
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| Secondary | 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. | Modified Intent to Treat (MITT) Population | Posted | Mean | Standard Error | nmol*minute/L | Baseline and 24 Months |
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AE data were collected from the time of subject enrollment through three months after the final product administrations (Total of 24 months after first study product administration)
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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 | DiaPep277 | DiaPep277 1.0 mg + 40 mg Mannitol in 0.5 mL lipid emulsion. DiaPep277: 1.0 mg dose, administered as subcutaneous injection, on 0, 1, 3, 6, 9, 12, 15, 18 and 21 months | 26 | 225 | 173 | 225 | ||
| EG001 | Placebo | Mannitol 40 mg in 0.5 mL lipid emulsion. Placebo: Mannitol (excipient) 40 mg, administered as subcutaneous injection on 1, 3, 6, 9, 12, 15, 18 and 21 months. | 14 | 231 | 164 | 231 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diabetic Ketoacidosis | Metabolism and nutrition disorders | Non-systematic Assessment |
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| Hypoglycaemia | Metabolism and nutrition disorders | Non-systematic Assessment |
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| Accidental Overdose | Psychiatric disorders | Non-systematic Assessment |
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| Hypoglycemic Coma | Metabolism and nutrition disorders | Non-systematic Assessment |
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| Major Depression | Psychiatric disorders | Non-systematic Assessment |
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| Hyperglycemia | Metabolism and nutrition disorders | Non-systematic Assessment |
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| Type 1 Diabetes Mellitus | Metabolism and nutrition disorders | Non-systematic Assessment |
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| Alcohol Poisoning | Psychiatric disorders | Non-systematic Assessment |
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| Jaw Fracture | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Laceration | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Wrist Fracture | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Concussion | Nervous system disorders | Non-systematic Assessment |
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| Head Injury | Nervous system disorders | Non-systematic Assessment |
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| Ligament Rupture | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Bronchopneumomnia | Infections and infestations | Non-systematic Assessment |
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| Diverticulitis | Gastrointestinal disorders | Non-systematic Assessment |
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| Gastritis Viral | Gastrointestinal disorders | Non-systematic Assessment |
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| Infection | Infections and infestations | Non-systematic Assessment |
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| Influenza | Infections and infestations | Non-systematic Assessment |
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| Gastroenteritis | Gastrointestinal disorders | Non-systematic Assessment |
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| Urinary Tract Infection | Infections and infestations | Non-systematic Assessment |
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| Facial Paresis | Nervous system disorders | Non-systematic Assessment |
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| Loss of Consciousness | Nervous system disorders | Non-systematic Assessment |
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| Migraine | Nervous system disorders | Non-systematic Assessment |
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| Mental Disorder | Psychiatric disorders | Non-systematic Assessment |
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| Cholelithiasis | Hepatobiliary disorders | Non-systematic Assessment |
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| Hepatitis | Hepatobiliary disorders | Non-systematic Assessment |
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| Nephrolithiasis | Renal and urinary disorders | Non-systematic Assessment |
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| Renal Colic | Renal and urinary disorders | Non-systematic Assessment |
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| Bronchiectasis | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Nasal Septum Deviation | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Erythema Nodosum | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Henoch-Schonlein Purpura | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Urticaria Cholinergic | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Death | Social circumstances | Non-systematic Assessment | This patient had an unspecified event leading to their death. The Investigator confirmed that the death certificate and autopsy results were unobtainable. |
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| Neutropenia | Blood and lymphatic system disorders | Non-systematic Assessment |
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| Death | Social circumstances | Non-systematic Assessment | In the placebo group a male patient's wife became pregnant with twins. Both were live births, but one died shortly after due to an intracranial hemorrhage, which was reported in the database within the placebo group |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | Non-systematic Assessment |
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| Influenza | Infections and infestations | Non-systematic Assessment |
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| Upper respiratory Tract Infection | Infections and infestations | Non-systematic Assessment |
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| Gastroenteritis | Infections and infestations | Non-systematic Assessment |
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| Pharyngitis | Infections and infestations | Non-systematic Assessment |
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| Tonsillitis | Infections and infestations | Non-systematic Assessment |
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| Urinary Tract Infection | Infections and infestations | Non-systematic Assessment |
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| Bronchitis | Infections and infestations | Non-systematic Assessment |
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| Sinusitis | Infections and infestations | Non-systematic Assessment |
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| Cystitis | Infections and infestations | Non-systematic Assessment |
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| Respiratory Tract Infection | Infections and infestations | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
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| Gastritis | Gastrointestinal disorders | Non-systematic Assessment |
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| Toothache | Gastrointestinal disorders | Non-systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | Non-systematic Assessment |
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| Abdominal Pain Upper | Gastrointestinal disorders | Non-systematic Assessment |
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| Pyrexia | General disorders | Non-systematic Assessment |
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| Injection Site Erythema | General disorders | Non-systematic Assessment |
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| Injection Site Pain | General disorders | Non-systematic Assessment |
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| Injection Site Induration | General disorders | Non-systematic Assessment |
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| Injury, Poisoning and Procedural Complications | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Blood Creatine Phosphokinase Increased | Investigations | Non-systematic Assessment |
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| Alanine Aminotransferase Increased | Investigations | Non-systematic Assessment |
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| Glycosylated Haemoglobin Increased | Investigations | Non-systematic Assessment |
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| Skin and Subcutaneous Tissue Disorders | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Back Pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Headache | Nervous system disorders | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | Non-systematic Assessment |
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| Respiratory, Thoracic and Mediastinal Disorders | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Hypercholesterolemia | Metabolism and nutrition disorders | Non-systematic Assessment |
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| Renal and Urinary Disorders | Renal and urinary disorders | Non-systematic Assessment |
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| Reproductive System and Breast Disorders | Reproductive system and breast disorders | Non-systematic Assessment |
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| Psychiatric disorders | Psychiatric disorders | Non-systematic Assessment |
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| Endocrine Disorders | Endocrine disorders | Non-systematic Assessment |
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| Eye Disorders | Eye disorders | Non-systematic Assessment |
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| Anemia | Blood and lymphatic system disorders | Non-systematic Assessment |
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| Hypertension | Vascular disorders | Non-systematic Assessment |
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| Immune System Disorders | Immune system disorders | Non-systematic Assessment |
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| Cardiac Disorders | Cardiac disorders | Non-systematic Assessment |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jeanne Novak | CBR International | 7207461190 | jnovak@cbrintl.com |
| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| Male |
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| Black |
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| Oriental |
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| Asian |
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| Other |
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