Open-Label Extension Study to Evaluate Long Term Safety and Treatment Effect of DiaPep277® (DIA-AID 2)

Andromeda Biotech

Status and phase

Terminated

Phase 3

Conditions

Type 1 Diabetes

Treatments

Drug: DiaPep277®

Study type

Interventional

Funder types

Industry

Identifiers

NCT01898286

1010

2013-002775-17 (EudraCT Number)

Details and patient eligibility

About

This is an extension study to evaluate the safety and tolerability of long-term treatment with DiaPep277® and to determine the long-term treatment effect of DiaPep277® on parameters of metabolic control and on preservation of beta-cell function in subjects who have long exposure to DiaPep277®.

Full description

Treatment with DiaPep277® is expected to be long-term; stopping treatment may result in the eventual loss of the preserved beta-cell function. Indeed, extension of phase 2 studies has shown that patients who were initially treated with DiaPep277® and maintained their initial beta-cell function, required continuation of treatment, losing beta-cell function if switched to Placebo. These extension studies were too small for the outcome to be statistically significant, but they suggested that continuation of treatment is needed for long-term maintenance of efficacy.

Therefore, in this extension study, patients who complete the 1001 phase 3 study (NCT01103284) and maintain clinically significant beta-cell function are offered a 2-year continuation of active treatment, since they are likely to benefit from use of the medication. The participation in the extension study will be offered to all eligible subjects who complete the 1001 study, regardless of the treatment arm allocation in the initial study.

By achieving long-term preservation of beta-cell function, patients are expected to maintain good management of the disease, manifesting as better glycemic control and fewer hypoglycemic events.

Enrollment

38 patients

Sex

All

Ages

18 to 47 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

patients with type 1 diabetes who participated in the 1001 study
residual beta-cell function demonstrated by stimulated C-peptide ≥ 0.20 nmol/L.

Exclusion criteria

The subject has any significant ongoing diseases or conditions that is likely to affect the subject's response to treatment
The subject has a history of any kind of malignant tumor.
The subject has clinical evidence of any diabetes-related complication
Subject has history of endogenous allergic reactivity:
The subject has a known immune deficiency