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

A

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

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

Trial contacts and locations

75

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Data sourced from clinicaltrials.gov

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