A phase III, multinational, randomised, double-blind, placebo-controlled, parallel-group study to investigate the clinical efficacy and safety of Diapep277 in newly diagnosed type I Diabetes patients.Ensayo Fase III, multinacional, aleatorizado, doble ciego, controlado con placebo y en grupos paralelos para estudiar la eficacia y la seguridad clínicas de diapep277 TM en pacientes con diabetes tipo 1 recien diagnosticados

Phase 1

• Conditions: Type I Diabetes; Level: LLTClassification code 10045228

• Registration Number: EUCTR2005-002590-73-ES
• Lead Sponsor: DeveloGen Autoimmune GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-10-14
• Study Completion: 2011-08-31
• Last Update Posted: 8 October 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

- Patients will be male or female between the ages of 16 and 45 years (inclusive)
- A diagnosis of T1D for up to 6 months at screening
- A diagnosis of T1D for up to 7 months at randomization
- HBA1c lower 9 at randomization
- Insulin dependency
- Fasting C-peptide levels more than 0.22 nmol/L
- Presence of at least 1 of the diabetes-related autoantibodies (IA-2, GAD or IA)
Are the trial subjects under 18? yes
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

- The patient has an insulin pump in situ or is treated with inhaled insulin.
- The patient has any significant diseases or conditions, including psychiatric
disorders and substance abuse that, in the opinion of the Investigator, are likely to
affect the patient's response to treatment or the ability to complete the study.
- The patient has a history of any kind of malignant tumor (not including basal cell
skin cancer).
- The patient has clinical evidence of any diabetes-related complication that in the
opinion of the Investigator would interfere with the patient's participation in and/or
completion of the study.
- Patient has history of allergic reactivity
- Severe allergic reaction or severe exacerbation of allergic asthma within 12 months prior to screening visit.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: To measure the effect of DiaPep 277 versus placebo in patients with Type I Diabetes Mellitus (T1D) on pancreatic beta-cell function;Primary end point(s): To demonstrate the efficacy of add-on therapy with DiaPep 277™ in patients with newly diagnosed Type I Diabetes;Secondary Objective: To assess the effect of DiaPep 277™ on insulin-dose requirement.<br>To assess the effect of DiaPep 277™ versus placebo on metabolic control.<br>To assess the safety and tolerability of DiaPep 277™. <br>To assess the effects of DiaPep 277™ on the occurrence of hypo-and hyperglycemic events.