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| Name | Class |
|---|---|
| Swedish Child Diabetes Foundation | OTHER |
| Ostergotland County Council, Sweden | OTHER |
| Diamyd Medical AB | INDUSTRY |
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The objectives of the main study is to:
The objective of the sub-study is to:
Eligible patients will be treated with 4 µg GAD-Alum into an inguinal lymph gland at three occasions, with one month intervals in combination with Vitamin D (14 000 IU/week) for 4 months, starting 1 month prior to first GAD-Alum injection.
A sub-study will include three adult patients from the main study and evaluate safety after a fourth injection with 4 μg GAD-Alum into an inguinal lymph gland in combination with oral vitamin D intake. The Prolonged Extension Study Period is 12 months and will start 30,5 months after baseline.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GAD-Alum+Vitamin D | Experimental | GAD-Alum (Diamyd) injected into Lymph Nodes Dosage and interval: One injection of 4 µg Diamyd will be administered into the lymph nodes at three occasions, with one month intervals Vitamin D (Calciferol) in oral solution. Dosage and interval: 2000 IU daily for 120 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GAD-Alum | Drug |
|
| |
| Vitamin D |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Injection Site Reactions Month 1 | Reactions of the injection site (Erythema, Oedema, Haematoma, Tenderness, Pain, Itching) | Month 1 |
| Number of Subjects With Injection Site Reactions Month 2 | Reactions of the injection site (Erythema, Oedema, Haematoma, Tenderness, Pain, Itching) | Month 2 |
| Number of Subjects With Injection Site Reactions Month 3 | Reactions of the injection site (Erythema, Oedema, Haematoma, Tenderness, Pain, Itching) | Month 3 |
| Number of Subjects With Injection Site Reactions Month 32 | Reactions of the injection site (Erythema, Oedema, Haematoma, Tenderness, Pain, Itching) | Month 32, extension period |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change in C-peptide AUC (Area Under the Curve) (Mean 120min) Value, Month 15 | Change from baseline to month 15 in C-peptide AUC (Area Under the Curve) (mean 120min) value AUC (mean 120min) (nmol/L) is the C-peptide AUC during an MMTT (nmol/L*minutes) divided by the duration of the MMTT (minutes) i.e. C-peptide weighted average concentration | Baseline to month 15 at 0, 30, 60, 90, 120 minutes post-dose |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Johnny Ludvigsson, Professor | Linkoeping University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Linköping University | Linköping | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33162978 | Derived | Casas R, Dietrich F, Barcenilla H, Tavira B, Wahlberg J, Achenbach P, Ludvigsson J. Glutamic Acid Decarboxylase Injection Into Lymph Nodes: Beta Cell Function and Immune Responses in Recent Onset Type 1 Diabetes Patients. Front Immunol. 2020 Oct 9;11:564921. doi: 10.3389/fimmu.2020.564921. eCollection 2020. | |
| 30009185 | Derived |
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| ID | Title | Description |
|---|---|---|
| FG000 | GAD-Alum+Vitamin D | GAD(Glutamic acid decarboxylase)-Alum (Diamyd) injected into Lymph Nodes Dosage and interval: One injection of 4 µg Diamyd will be administered into the lymph nodes at three occasions, with one month intervals Vitamin D (Calciferol) in oral solution. Dosage and interval: 2000 IU daily for 120 days GAD-Alum Vitamin D |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Main Study |
| |||||||||||||
| Extension |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | GAD-Alum+Vitamin D | GAD-Alum (Diamyd) injected into Lymph Nodes Dosage and interval: One injection of 4 µg Diamyd will be administered into the lymph nodes at three occasions, with one month intervals Vitamin D (Calciferol) in oral solution. Dosage and interval: 2000 IU daily for 120 days GAD-Alum Vitamin D |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Number of Subjects With Injection Site Reactions Month 1 | Reactions of the injection site (Erythema, Oedema, Haematoma, Tenderness, Pain, Itching) | Posted | Count of Participants | Participants | Month 1 |
|
|
During main study period (baseline to month 30) and extension (month 37 and 43)
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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 | GAD-Alum+Vitamin D | GAD-Alum (Diamyd) injected into Lymph Nodes Dosage and interval: One injection of 4 µg Diamyd will be administered into the lymph nodes at three occasions, with one month intervals Vitamin D (Calciferol) in oral solution. Dosage and interval: 2000 IU daily for 120 days GAD-Alum Vitamin D |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Retinopathy | Eye disorders | MedDRA (20.1) | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ã…sa Carlsheimer | 4Pharma AB | +4672244516 | asa.carlsheimer@4pharma.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 11, 2018 | Mar 19, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| ID | Term |
|---|---|
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D014807 | Vitamin D |
| D002762 | Cholecalciferol |
| ID | Term |
|---|---|
| D012632 | Secosteroids |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
Not provided
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| Drug |
|
|
| Mean Change in C-peptide AUC(Mean 120min) Value, Month 30 | Change from baseline to month 30 in C-peptide AUC(mean 120min) value AUC (mean 120min) (nmol/L) is the C-peptide AUC during an MMTT (nmol/L*minutes) divided by the duration of the MMTT (minutes) i.e. C-peptide weighted average concentration | Baseline to month 30 at 0, 30, 60, 90, 120 minutes post-dose |
| Mean Change in C-peptide AUC(Mean 120min) Value, Month 43 | Change from baseline to month 43 in C-peptide AUC(mean 120min) value AUC (mean 120min) (nmol/L) is the C-peptide AUC during an MMTT (nmol/L*minutes) divided by the duration of the MMTT (minutes) i.e. C-peptide weighted average concentration | Baseline to month 43, extension period at 0, 30, 60, 90, 120 minutes post-dose |
| Mean Change in C-peptide 90-minute Value, Month 15 | Change from baseline to month 15 in C-peptide 90-minute value | Baseline to month 15 |
| Mean Change in C-peptide 90-minute Value, Month 30 | Change from baseline to month 30 in C-peptide 90-minute value | Baseline to month 30 |
| Mean Change in C-peptide 90-minute Value, Month 43 | Change from baseline to month 43 in C-peptide 90-minute value | Baseline to month 43, extension period |
| Mean Change in Fasting C-peptide Value, Month 15 | Change from baseline to month 15 in fasting C-peptide value | Baseline to month 15 |
| Mean Change in Fasting C-peptide Value, Month 30 | Change from baseline to month 30 in fasting C-peptide value | Baseline to month 30 |
| Mean Change in Fasting C-peptide Value, Month 43 | Change from baseline to month 43 in fasting C-peptide value | Baseline to month 43, extension period |
| Mean Change in HbA1c, Month 15 | Change from baseline to month 15 in HbA1c | Baseline to month 15 |
| Mean Change in HbA1c, Month 30 | Change from baseline to month 30 in HbA1c | Baseline to month 30 |
| Mean Change in HbA1c, Month 43 | Change from baseline to month 43 in HbA1c | Baseline to month 43, extension period |
| External Insulin Dose, Baseline | External insulin dose at baseline | Baseline |
| External Insulin Dose, Month 15 | External insulin dose at month 15 | Month 15 |
| External Insulin Dose, Month 30 | External insulin dose at month 30 | Month 30 |
| External Insulin Dose, Month 43 | External insulin dose at month 43 | Month 43, extension period |
| Mean IDAA1c Values, Baseline | Insulin dose-adjusted HbA1c (IDAA1c) | Baseline |
| Mean IDAA1c Values, Month 15 | Insulin dose-adjusted HbA1c (IDAA1c) | Month 15 |
| Mean IDAA1c Values, Month 30 | Insulin dose-adjusted HbA1c (IDAA1c) | Month 30 |
| Mean IDAA1c Values, Month 43 | Insulin dose-adjusted HbA1c (IDAA1c) | Month 43, extension period |
| Tavira B, Barcenilla H, Wahlberg J, Achenbach P, Ludvigsson J, Casas R. Intralymphatic Glutamic Acid Decarboxylase-Alum Administration Induced Th2-Like-Specific Immunomodulation in Responder Patients: A Pilot Clinical Trial in Type 1 Diabetes. J Diabetes Res. 2018 May 24;2018:9391845. doi: 10.1155/2018/9391845. eCollection 2018. |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Weight | Mean | Standard Deviation | kg |
|
| BMI | Mean | Standard Deviation | kg/m^2 |
|
| Type 1 diabetes duration | Mean | Standard Deviation | days |
|
| GADA (Antibodies to GAD with molecular mass 65,000) | Mean | Standard Deviation | U/mL^2 |
|
| Weighted C-peptide | Mean | Standard Deviation | nmol/L |
|
| 90-minute C-peptide | Mean | Standard Deviation | nmol/L |
|
| Fasting C-peptide | Mean | Standard Deviation | nmol/L |
|
| HbA1c | Mean | Standard Deviation | mmol/mol |
|
| Average insulin dose/kg/24 h | Mean | Standard Deviation | IU |
|
| IDAA1c | Mean | Standard Deviation | IU/kg/day |
|
|
|
| Primary | Number of Subjects With Injection Site Reactions Month 2 | Reactions of the injection site (Erythema, Oedema, Haematoma, Tenderness, Pain, Itching) | Posted | Count of Participants | Participants | Month 2 |
|
|
|
| Primary | Number of Subjects With Injection Site Reactions Month 3 | Reactions of the injection site (Erythema, Oedema, Haematoma, Tenderness, Pain, Itching) | Posted | Count of Participants | Participants | Month 3 |
|
|
|
| Primary | Number of Subjects With Injection Site Reactions Month 32 | Reactions of the injection site (Erythema, Oedema, Haematoma, Tenderness, Pain, Itching) | Posted | Count of Participants | Participants | Month 32, extension period |
|
|
|
| Secondary | Mean Change in C-peptide AUC (Area Under the Curve) (Mean 120min) Value, Month 15 | Change from baseline to month 15 in C-peptide AUC (Area Under the Curve) (mean 120min) value AUC (mean 120min) (nmol/L) is the C-peptide AUC during an MMTT (nmol/L*minutes) divided by the duration of the MMTT (minutes) i.e. C-peptide weighted average concentration | Posted | Mean | Standard Deviation | nmol/L | Baseline to month 15 at 0, 30, 60, 90, 120 minutes post-dose |
|
|
|
| Secondary | Mean Change in C-peptide AUC(Mean 120min) Value, Month 30 | Change from baseline to month 30 in C-peptide AUC(mean 120min) value AUC (mean 120min) (nmol/L) is the C-peptide AUC during an MMTT (nmol/L*minutes) divided by the duration of the MMTT (minutes) i.e. C-peptide weighted average concentration | Posted | Mean | Standard Deviation | nmol/L | Baseline to month 30 at 0, 30, 60, 90, 120 minutes post-dose |
|
|
|
| Secondary | Mean Change in C-peptide AUC(Mean 120min) Value, Month 43 | Change from baseline to month 43 in C-peptide AUC(mean 120min) value AUC (mean 120min) (nmol/L) is the C-peptide AUC during an MMTT (nmol/L*minutes) divided by the duration of the MMTT (minutes) i.e. C-peptide weighted average concentration | Posted | Mean | Standard Deviation | nmol/L | Baseline to month 43, extension period at 0, 30, 60, 90, 120 minutes post-dose |
|
|
|
| Secondary | Mean Change in C-peptide 90-minute Value, Month 15 | Change from baseline to month 15 in C-peptide 90-minute value | Posted | Mean | Standard Deviation | nmol/L | Baseline to month 15 |
|
|
|
| Secondary | Mean Change in C-peptide 90-minute Value, Month 30 | Change from baseline to month 30 in C-peptide 90-minute value | Posted | Mean | Standard Deviation | nmol/L | Baseline to month 30 |
|
|
|
| Secondary | Mean Change in C-peptide 90-minute Value, Month 43 | Change from baseline to month 43 in C-peptide 90-minute value | Posted | Mean | Standard Deviation | nmol/L | Baseline to month 43, extension period |
|
|
|
| Secondary | Mean Change in Fasting C-peptide Value, Month 15 | Change from baseline to month 15 in fasting C-peptide value | Posted | Mean | Standard Deviation | nmol/L | Baseline to month 15 |
|
|
|
| Secondary | Mean Change in Fasting C-peptide Value, Month 30 | Change from baseline to month 30 in fasting C-peptide value | Posted | Mean | Standard Deviation | nmol/L | Baseline to month 30 |
|
|
|
| Secondary | Mean Change in Fasting C-peptide Value, Month 43 | Change from baseline to month 43 in fasting C-peptide value | Posted | Mean | Standard Deviation | nmol/L | Baseline to month 43, extension period |
|
|
|
| Secondary | Mean Change in HbA1c, Month 15 | Change from baseline to month 15 in HbA1c | Posted | Mean | Standard Deviation | mmol/mol | Baseline to month 15 |
|
|
|
| Secondary | Mean Change in HbA1c, Month 30 | Change from baseline to month 30 in HbA1c | Posted | Mean | Standard Deviation | mmol/mol | Baseline to month 30 |
|
|
|
| Secondary | Mean Change in HbA1c, Month 43 | Change from baseline to month 43 in HbA1c | Posted | Mean | Standard Deviation | mmol/mol | Baseline to month 43, extension period |
|
|
|
| Secondary | External Insulin Dose, Baseline | External insulin dose at baseline | Posted | Mean | Standard Deviation | IU/kg/day | Baseline |
|
|
|
| Secondary | External Insulin Dose, Month 15 | External insulin dose at month 15 | Posted | Mean | Standard Deviation | IU/kg/day | Month 15 |
|
|
|
| Secondary | External Insulin Dose, Month 30 | External insulin dose at month 30 | Posted | Mean | Standard Deviation | IU/kg/day | Month 30 |
|
|
|
| Secondary | External Insulin Dose, Month 43 | External insulin dose at month 43 | Posted | Mean | Standard Deviation | IU/kg/day | Month 43, extension period |
|
|
|
| Secondary | Mean IDAA1c Values, Baseline | Insulin dose-adjusted HbA1c (IDAA1c) | Posted | Mean | Standard Deviation | IU/kg/day | Baseline |
|
|
|
| Secondary | Mean IDAA1c Values, Month 15 | Insulin dose-adjusted HbA1c (IDAA1c) | Posted | Mean | Standard Deviation | IU/kg/day | Month 15 |
|
|
|
| Secondary | Mean IDAA1c Values, Month 30 | Insulin dose-adjusted HbA1c (IDAA1c) | Posted | Mean | Standard Deviation | IU/kg/day | Month 30 |
|
|
|
| Secondary | Mean IDAA1c Values, Month 43 | Insulin dose-adjusted HbA1c (IDAA1c) | Posted | Mean | Standard Deviation | IU/kg/day | Month 43, extension period |
|
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| 11 |
| 12 |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA (20.1) | Non-systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (20.1) | Non-systematic Assessment |
|
| Bowel movement irregularity | Gastrointestinal disorders | MedDRA (20.1) | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA (20.1) | Non-systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | MedDRA (20.1) | Non-systematic Assessment |
|
| Food poisoning | Gastrointestinal disorders | MedDRA (20.1) | Non-systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA (20.1) | Non-systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA (20.1) | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (20.1) | Non-systematic Assessment |
|
| Fatigue | General disorders | MedDRA (20.1) | Non-systematic Assessment |
|
| Injection site pain | General disorders | MedDRA (20.1) | Non-systematic Assessment |
|
| Injection site reaction | General disorders | MedDRA (20.1) | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA (20.1) | Non-systematic Assessment |
|
| Seasonal allergy | Immune system disorders | MedDRA (20.1) | Non-systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA (20.1) | Non-systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA (20.1) | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA (20.1) | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA (20.1) | Non-systematic Assessment |
|
| Rhinitis | Infections and infestations | MedDRA (20.1) | Non-systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA (20.1) | Non-systematic Assessment |
|
| Tooth infection | Infections and infestations | MedDRA (20.1) | Non-systematic Assessment |
|
| Viral infection | Infections and infestations | MedDRA (20.1) | Non-systematic Assessment |
|
| Concussion | Injury, poisoning and procedural complications | MedDRA (20.1) | Non-systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA (20.1) | Non-systematic Assessment |
|
| Fibula fracture | Injury, poisoning and procedural complications | MedDRA (20.1) | Non-systematic Assessment |
|
| Joint dislocation | Injury, poisoning and procedural complications | MedDRA (20.1) | Non-systematic Assessment |
|
| Skin injury | Injury, poisoning and procedural complications | MedDRA (20.1) | Non-systematic Assessment |
|
| Hepatic enzyme increased | Investigations | MedDRA (20.1) | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Non-systematic Assessment |
|
| Plantar fascilitis | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Non-systematic Assessment |
|
| Lipoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.1) | Non-systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA (20.1) | Non-systematic Assessment |
|
| Attention deficit/hyperactivity disorder | Psychiatric disorders | MedDRA (20.1) | Non-systematic Assessment |
|
| Autism spectrum disorder | Psychiatric disorders | MedDRA (20.1) | Non-systematic Assessment |
|
| Panic disorder | Psychiatric disorders | MedDRA (20.1) | Non-systematic Assessment |
|
| Sleep disorder | Psychiatric disorders | MedDRA (20.1) | Non-systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Non-systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA (20.1) | Non-systematic Assessment |
|
| Ingrowing nail | Skin and subcutaneous tissue disorders | MedDRA (20.1) | Non-systematic Assessment |
|
| Skin irritation | Skin and subcutaneous tissue disorders | MedDRA (20.1) | Non-systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA (20.1) | Non-systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA (20.1) | Non-systematic Assessment |
|
Not provided
Not provided
| D002782 |
| Cholestenes |
| D002776 | Cholestanes |
| D013261 | Sterols |
| D008563 | Membrane Lipids |
| D008055 | Lipids |
| Title |
|---|
| Measurements |
|---|
|
| Tenderness |
|
| Pain |
|
| Itching |
|
| Other |
|
| Title |
|---|
| Measurements |
|---|
|
| Tenderness |
|
| Pain |
|
| Itching |
|
| Other |
|
| Title | Measurements |
|---|
|
| Tenderness |
|
| Pain |
|
| Itching |
|
| Other |
|