A PHASE III, MULTINATIONAL, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO INVESTIGATE THE CLINICAL EFFICACY AND SAFETY OF DIAPEP277 IN NEWLY DIAGNOSED TYPE 1 DIABETES SUBJECTS - DIA-AID 2

Active, not recruiting

• Conditions: Subjects newly diagnosed with type 1 diabetes; MedDRA version: 12.1Level: LLTClassification code 10045228Term: Type I diabetes mellitus

• Registration Number: EUCTR2009-015929-37-IT
• Lead Sponsor: ANDROMEDA BIOTECH LTD.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-07-06
• Last Update Posted: 2015-09-14

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: 450

Inclusion Criteria

• Male or female subjects between the ages of 20 and 45 years (inclusive) at screening. • A diagnosis of T1D according to the American Diabetes Association and World Health Organization (ADA/WHO) criteria for up to 5 months at screening • A diagnosis of T1D for up to 6 months at randomization (baseline) • Subject has been on insulin since diagnosis of T1D. • Fasting C-peptide levels ? 0.22 nmol/L and <0.8 nmol/L. • Presence of at least 1 of the diabetes-related autoantibodies (IA-2A, GADA, or IAA) • Body mass index (BMI) =17 kg/m2 and < 30 kg/m2 at screening
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1 The subject has any significant diseases or conditions, including psychiatric disorders and substance abuse that, in the opinion of the Investigator, are likely to affect the subject`s response to treatment or the ability to complete the study. 2 The subject has a history of any kind of malignant tumor. 3 The subject has clinical evidence of any diabetes-related complication that in the opinion of the Investigator would interfere with the subject`s participation in and/or completion of the study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified