Conditions: Type 1 Diabetes
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 457
Healthy volunteers: no

Brief summary:
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.

Detailed description:

Arms:
arm 1: DiaPep277 1.0 mg + 40 mg Mannitol in 0.5 mL lipid emulsion. arm 2: Mannitol 40 mg in 0.5 mL lipid emulsion.

Interventions: intervention 1: DiaPep277 intervention 2: Placebo
Intervention descriptions: intervention 1: 1.0mg dose, administered as subcutaneous injection, on 0, 1, 3, 6, 9, 12, 15, 18 and 21 months intervention 2: Mannitol (excipient) 40 mg, administered as subcutaneous injection on 1, 3, 6, 9, 12, 15, 18 and 21 months.

Protocol document: