A Phase III Study to Investigate the Impact of Diamyd in Patients Newly Diagnosed With Type 1 Diabetes (EU)

Diamyd Therapeutics

Status and phase: Terminated; Phase 3

Conditions: Type 1 Diabetes Mellitus

Treatments: Drug: Placebo; Drug: rhGAD65

Study type: Interventional

Funder types: Industry

Identifiers

NCT00723411

D/P3/07/4

Details and patient eligibility

About

The purpose of this study is to determine whether Diamyd (rhGAD65 formulated in alum) is effective in preserving the body's own insulin producing capacity in patients recently diagnosed with type 1 diabetes.

Enrollment: 334 patients

Sex: All

Ages: 10 to 20 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Main Inclusion Criteria:

• Male and female patients between 10 and 20 years of age
• Insulin dependent type 1 diabetes mellitus diagnosed within the previous 3 months at time of screening
• Fasting C-peptide level at time of screening above 0.1 nmol/L
• Elevated GAD65 antibodies (GADA) at time of screening

Main Exclusion Criteria:

• Treatment with immunosuppressants or any anti-diabetic medications other than insulin
• A history of certain diseases or conditions (e.g. anemia, HIV, hepatitis, epilepsy, head trauma, neurological diseases or cerebrovascular accident, alcohol or drug abuse etc)
• Treatment with any vaccine within 1 month prior to planned first Diamyd dose or planned treatment with vaccine up to 2 months after the last injection with Diamyd, excluding the influenza vaccine
• 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 Diamyd 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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334 participants in 3 patient groups, including a placebo group

A

Active Comparator group

Description:

This arm will receive 2 subcutaneous injections with 20 µg Diamyd on Days 1 and 30, i.e., 1 prime and 1 booster dose, followed by 2 additional single doses with Diamyd 20 µg on Days 90 and 270.

Treatment:

Drug: rhGAD65

Drug: rhGAD65

B

Active Comparator group

Description:

This arm will receive 2 subcutaneous injections with 20 µg Diamyd on Days 1 and 30, i.e., 1 prime and 1 booster dose, followed by 2 additional single doses with placebo on Days 90 and 270.

Treatment:

Drug: rhGAD65

Drug: rhGAD65

C

Placebo Comparator group

Description:

This arm will receive 4 injections of placebo, 1 each on Days 1, 30, 90, and 270.

Treatment:

Drug: Placebo