NCT02352974

GAD-Alum (Diamyd) Administered Into Lymph Nodes in Combination With Vitamin D in Type 1 Diabetes (DIAGNODE-1)

Open Label Pilot Trial in Adults With Recent-onset T1D to Evaluate the Safety, Diabetes Status and Immune Response of GAD-antigen (Diamyd®) Therapy Administered Into Lymph Nodes in Combination With an Oral Vitamin D Regimen

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Johnny Ludvigsson · Other Government
• Sex: All
• Age: 12 Years – 30 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Diabetes Mellitus, Type 1

Interventions

Type	Name	Description
DRUG	GAD-Alum
DRUG	Vitamin D

Timeline

• Start date: 2015-01-01
• Primary completion: 2019-10-01
• Completion: 2019-10-01
• First posted: 2015-02-02
• Last updated: 2020-04-27
• Results posted: 2020-04-27

Locations

1 site across 1 country: Sweden