CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 475 enrolled
Drug / intervention
DiaPep277 +1 moredrug
Likely dose
DiaPep277 1.0 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01103284
NCT01103284Phase 3Completed
CompareCT.gov

A Phase 3, 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

Andromeda Biotech Ltd.·interventional·Posted Apr 14, 2010·Updated May 26, 2016

In Brief

A Phase 3 clinical trial evaluating DiaPep277 and Placebo for Type 1 Diabetes Mellitus. Completed, enrolled 475 participants across 75 sites in 14 countries.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 1 Diabetes Mellitus
CountriesAustria, Belarus, Canada, Czechia, Finland, Germany, Hungary, Israel, Italy, Lithuania, Poland, Russia, Spain, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedApr 14, 2010
Enrollment StartApr 1, 2010
Primary CompletionOct 1, 2014
TodayJul 2, 2026
Enrollment to primary: 4.5 yearsPosted 16.2 years ago

Interventions

DiaPep277drug

1.0 mg dose in 0.5 mL of solution

Placebodrug

40 mg mannitol in 0.5 mL of solution. Dosing: 0, 1, 3, 6, 9, 12, 15, 18, 21, 24 months