Efficacy and Safety Study of DiaPep277 in Newly Diagnosed Type 1 Diabetes Adults (DIA-AID2)

Andromeda Biotech

Status and phase: Completed; Phase 3

Conditions: Type 1 Diabetes Mellitus

Treatments: Drug: Placebo; Drug: DiaPep277

Study type: Interventional

Funder types: Industry

Identifiers

NCT01103284

DiaPep277-1001

Details and patient eligibility

About

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.

Enrollment: 475 patients

Sex: All

Ages: 20 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• clinical diagnosis of type 1 diabetes within last 6 months
• Age 20-45 years
• fasting basal C-peptide equal or greater than 0.22 nmol/L, lower than 0.8 nmol/L
• BMI between 17 and 30 at screening

Exclusion criteria

• Significant disease or condition other than type 1 diabetes
• Diabetes-related complications
• Ongoing treatment with immunosuppressive or immunomodulating agents including chronic corticosteroids

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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475 participants in 2 patient groups, including a placebo group

DiaPep277

Experimental group

Description:

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.

Treatment:

Drug: DiaPep277

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo