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

Johnny Ludvigsson

Status and phase: Completed; Phase 2

Conditions: Diabetes Mellitus, Type 1

Treatments: Biological: GAD-Alum (Diamyd) 20 µg; Drug: Ibuprofen; Drug: Vitamin D; Biological: GAD-Alum (Diamyd) 20 µg X 2

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01785108

DIABGAD-1

Details and patient eligibility

About

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

Enrollment: 60 patients

Sex: All

Ages: 10 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 4 patient groups, including a placebo group

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

Active Comparator group

Description:

* 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

Treatment:

Biological: GAD-Alum (Diamyd) 20 µg

Drug: Vitamin D

Drug: Ibuprofen

GAD-Alum (Diamyd) 20µg and Vitamin D

Active Comparator group

Description:

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

Treatment:

Biological: GAD-Alum (Diamyd) 20 µg

Drug: Vitamin D

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

Active Comparator group

Description:

* 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

Treatment:

Drug: Vitamin D

Biological: GAD-Alum (Diamyd) 20 µg X 2

Placebo

Placebo Comparator group

Treatment:

Drug: Vitamin D

Biological: GAD-Alum (Diamyd) 20 µg X 2

Drug: Ibuprofen