GAD-Alum (Diamyd) Administered Into Lymph Nodes in Combination With Vitamin D in Type 1 Diabetes (DIAGNODE-1)
Status:
Completed
Trial end date:
2019-10-01
Target enrollment:
Participant gender:
Summary
The objectives of the main study is to:
- Evaluate the safety of giving GAD-Alum (Glutamic acid decarboxylase) (Diamyd) directly
into lymph glands in combination with an oral vitamin D regimen
- Evaluate how the above mentioned treatments influence the immune system and endogenous
insulin secretion.
The objective of the sub-study is to:
- Evaluate safety after a fourth injection with 4 μg GAD-Alum direct into an inguinal
lymph gland in 3 adult patients from the main study
- Evaluate how the above mentioned treatment influences the immune system and endogenous
insulin secretion.
Phase:
Phase 1
Details
Lead Sponsor:
Johnny Ludvigsson
Collaborators:
Diamyd Medical AB Ostergotland County Council, Sweden Sahlgrenska University Hospital, Sweden Swedish Child Diabetes Foundation