NCT01785108

DIABGAD - Trial to Preserve Insulin Secretion in Type 1 Diabetes Using GAD-Alum (Diamyd) in Combination With Vitamin D and Ibuprofen

Pilot Trial to Preserve Residual Insulin Secretion in Children and Adolescents With Recent Onset Type 1 Diabetes by Using GAD-antigen (Diamyd) Therapy in Combination With Vitamin D and Ibuprofen

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Johnny Ludvigsson · Other Government
• Sex: All
• Age: 10 Years – 18 Years
• Healthy volunteers: Not accepted

Summary

The objectives of this study is to * evaluate the safety and influence of treatment with GAD-Alum (Diamyd) combined with Vitamin D and Ibuprofen on preservation of residual insulin secretion in recently diagnosed Type 1 Diabetes * evaluate how the above mentioned treatments influence the immune system of the subjects and interact with any viral infections * evaluate the safety and influence of treatment with double dose of GAD-Alum (Diamyd) plus Vitamin D on the immune system, viral infections, and on preservation of residual insulin secretion in recently diagnosed Type 1 Diabetes

Conditions

• Diabetes Mellitus, Type 1

Interventions

Type	Name	Description
BIOLOGICAL	GAD-Alum (Diamyd) 20 µg
BIOLOGICAL	GAD-Alum (Diamyd) 20 µg X 2
DRUG	Vitamin D
DRUG	Ibuprofen

Timeline

• Start date: 2013-02-01
• Primary completion: 2017-03-01
• Completion: 2017-03-01
• First posted: 2013-02-07
• Last updated: 2017-08-23

Locations

10 sites across 1 country: Sweden