Conditions: Type 1 Diabetes Mellitus
Keywords: beta-cells autoimmune Diabetes immunomodulation
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 475
Healthy volunteers: no

Brief summary:
This study will look at the treatment effect of DiaPep277 on preservation of beta-cell function, as defined by meal-stimulated secretion of insulin. DiaPep277 is a peptide that changes the way the immune system behaves, stopping its attack on the beta-cells.

Adults (\>20 years) with newly diagnosed (\<6 months) type 1 diabetes will be treated with 10 injections of DiaPep277 or Placebo over a 2-year treatment and follow-up period.

Detailed description:

Arms:
arm 1: Administration of 1 mg DiaPep277®, subcutaneously (s.c.) in the upper arm at 0, 1, 3, 6, 9, 12, 15, 18, 21, and 24 months, for a total of 10 administrations. arm 2: Administration of placebo, subcutaneously (s.c.) in the upper arm at 0, 1, 3, 6, 9, 12, 15, 18, 21, and 24 months, for a total of 10 administrations.

Interventions: intervention 1: DiaPep277 intervention 2: Placebo
Intervention descriptions: intervention 1: 1.0 mg dose in 0.5 mL of solution intervention 2: 40 mg mannitol in 0.5 mL of solution.

Dosing: 0, 1, 3, 6, 9, 12, 15, 18, 21, 24 months

Protocol document: