Trial | NCT01785108  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    vitamin d3 ibuprofen diamyd ...

  • Study Participants

    60
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
Study Started
Feb 28
2013
Primary Completion
Mar 31
2017
Study Completion
Mar 31
2017
Last Update
Aug 23
2017

Biological GAD-Alum (Diamyd) 20 µg

Biological GAD-Alum (Diamyd) 20 µg X 2

Drug Vitamin D

Drug Ibuprofen

GAD-Alum (Diamyd) 20µg, Vitamin D and Ibuprofen Active Comparator

GAD-Alum (Diamyd) 20 µg given twice with one month interval Vitamin D oral drops, 2000 IU/day, from Day 1 to Day 450 Ibuprofen, 400 mg/day, from Day 1 to Day 90

GAD-Alum (Diamyd) 20µg and Vitamin D Active Comparator

GAD-Alum (Diamyd) 20 µg given twice with one month interval Vitamin D oral drops, 2000 IU/day, from Day 1 to Day 450

GAD-Alum (Diamyd) 20 µg x 2 and Vitamin D Active Comparator

GAD-Alum (Diamyd) 20 µg X 2 given twice with one month interval Vitamin D oral drops, 2000 IU/day, from Day 1 to Day 450

Placebo Placebo Comparator

Criteria 

Main Inclusion Criteria:

Male and female patients between 10 and 18 years of age
Insulin dependent Type 1 Diabetes mellitus diagnosed within the previous 4 months at time of screening
Fasting C-peptide level at time of screening above or equal to 0.12 nmol/L
Elevated GAD65 antibodies (GADA) at time of screening

Main Exclusion Criteria:

Treatment with immunosuppressants, continuous anti-inflammatory drug, Vitamin D or any anti-diabetic medications other than insulin
A history of certain diseases or conditions (e.g. anemia, HIV, epilepsy, head trauma, neurological diseases or cerebrovascular accident, alcohol or drug abuse etc)
Treatment with any vaccine within 4 months prior to first planned administration of GAD-Alum/placebo or planned treatment with vaccine up to 4 months after the last injections with GAD-Alum/Placebo, including influenza vaccines
Participation in other clinical trials with a new chemical entity within the previous 3 months
Pregnancy or planned pregnancy within 1 year after the last GAD-Alum/placebo dose
Presence of associated serious disease or condition which in the opinion of the investigator makes the patient non-eligible for the study
No Results Posted