Efficacy Study of DiaPep277 in Newly Diagnosed Type 1 Diabetes Patients (DIA-AID)

Andromeda Biotech

Status and phase: Completed; Phase 3

Conditions: Type 1 Diabetes

Treatments: Drug: DiaPep277; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00615264

ISRCTN55429664

901

Details and patient eligibility

About

The purpose of this study is to determine if DiaPep277 can effectively protect the internal production of insulin in patients newly diagnosed with type 1 diabetes, by stopping the immune destruction of insulin-producing beta-cells in the pancreas. DiaPep277 acts on the immune system and is expected to prevent further destruction of the beta-cells by stimulating regulatory responses, without causing immunological suppression.

Enrollment: 457 patients

Sex: All

Ages: 16 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• A diagnosis of type 1 diabetes for up to 3 months at screening
• Insulin dependency
• Fasting C-peptide levels >= 0.22 nmol/L
• Presence of at least 1 of the diabetes-related autoantibodies (IA-2A, GAD or IA)

Exclusion criteria

• Pregnancy or intent to conceive in the next 2 years
• Significant diseases that could affect response to treatment, such as tumors, psychiatric disorders, substance abuse, severe allergies or diabetes-related complications.
• Patient has immune deficiency or receives immuno-suppressive or cytotoxic drugs.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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457 participants in 2 patient groups, including a placebo group

DiaPep277

Experimental group

Description:

DiaPep277 1.0 mg + 40 mg Mannitol in 0.5 mL lipid emulsion.

Treatment:

Drug: DiaPep277

Placebo

Placebo Comparator group

Description:

Mannitol 40 mg in 0.5 mL lipid emulsion.

Treatment:

Drug: Placebo