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| ID | Type | Description | Link |
|---|---|---|---|
| EUDRACT 2004-001998-25 |
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This is a study to investigate the safety of 20ug Diamyd® (rhGAD65 formulated in Alhydrogel®), administered subcutaneously four weeks apart in patients with Latent Autoimmune Diabetes in Adult (LADA).
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rhGAD65 formulated in Alhydrogel® (Diamyd®) | Drug | 20 micrograms of rhGAD65 formulated in Alhydrogel® administered subcutaneously twice 4 weeks apart |
| Measure | Description | Time Frame |
|---|---|---|
| The development over time of safety variables, i.e. injection site discomfort, vital signs, laboratory values and AEs/SAEs as well as development of diabetes status, i.e. HbA1c, C-peptide, blood glucose and insulin requirement. | 30 months |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carl-David Agardh, MD, phD | University Hospital MAS, Malmö, Sweden | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alingsås Hospital | Alingsås | Sweden | ||||
| Falu Hospital |
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| Falun |
| Sweden |
| Capio Lundby Hospital | Gothenburg | Sweden |
| Härnösand Hospital | Härnösand | Sweden |
| Helsingborg Hospital | Helsingborg | Sweden |
| Karlstad Central Hospital | Karlstad | Sweden |
| Central Hospital, Kristianstad | Kristianstad | Sweden |
| Sunderby Hospital | Luleå | Sweden |
| University Hospital MAS | Malmö | Sweden |
| Vrinnevi Hospital | Norrköping | Sweden |
| Odensala Health Clinic | Östersund | Sweden |
| Skellefteå Hospital | Skellefteå | Sweden |
| S:t Göran Hospital | Stockholm | Sweden |
| Stockholm South General Hospital | Stockholm | Sweden |
| Norrlands University Hospital | Umeå | Sweden |
| Uppsala University Hospital | Uppsala | Sweden |
| Växjö Central Hospital | Vaxjo | Sweden |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D001327 | Autoimmune Diseases |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D000536 | Aluminum Hydroxide |
| ID | Term |
|---|---|
| D006878 | Hydroxides |
| D000468 | Alkalies |
| D007287 | Inorganic Chemicals |
| D017607 | Aluminum Compounds |
| D000838 | Anions |
| D007477 | Ions |
| D004573 | Electrolytes |
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